The Effect of the Addition of Oligofructose to the Usual Diets of Adults on Marginal Nutrient Intake Brandee Monarch Food Science and Human Nutrition Department College of Agricultural and Life Sciences Faculty Advisor Dr. Wendy Dahl
Ab stract F iber, calcium, potassium and vitamin D are nutrients of public health concern because Americans do not consume the recommended dietary allowance (RDA) or Average Intake (AI) for these nutrients Sodium is a nutrient of concern due to population wid e intakes above the safe upper limit (UL). Consumption of foods with added fiber has been suggested as a way of meeting fiber recommendations. Oligofructose a fiber, has been added to foods because of its beneficial physiological effects in humans. The pu rpose of this study was to determine if encouraging adults to meet their fiber intake through foods with added fiber would impact the intake of not only fiber, but also calcium potassium, vitamin D and sodium. To evaluate this, ninety eight participants w ere enrolled i n an 8 week study where they were randomly assigned to a treatment or control group. The treatment group consumed a snack bar and yogurt containing a total of 16 g of oligofructose every day while the control group consumed simila r snack foods without the added fiber. Participants completed online 24 hour dietary recalls (ASA 24) during baseline and during weeks 4, 6, and 8. Total fiber intake was significantly higher for the group consuming oligofructose compared to baseline and t o the control group. C alcium and potassium intake increased from baseline to treatment for both the trea tment and control groups. E ating yogurt and snack bars that have added fiber can help increase calcium and potassium intake and can help individuals mee t th e recommended intake of fiber.
Section 1: Introduction 1.1 Nutrients of Concern According to the Dietary Guidelin es for Americans ( 2010 ) fiber cal cium, potassium vitamin D, and sodium are nutrients of public health concern. Americans consume sodi um in excess of the recommended amount. The average sodium intake of Americans ages 2 years and older is 3,400 mg per day although t he recommended sodium intake is less than 2,300 mg per day (D ietary Guidelines for Americans 2010). Increased sodium intake can lead to the development of hypertension. Americans cons ume potassium, calcium, fiber, and vitamin D in amounts less than the recommended intake for these nutrients. This is because consumption of fruits, vegetables, whole grains, and milk is lower tha n recommended. Adequate potassium intake can result in a decrease in blood pressure, decreased bone loss, and decreased risk of developing kidney stones (Dietary Guidelines for Americ ans 2010). Adequate calcium intake is important for optimal bone health and the prevention of osteoporosis. Adequate vitamin D intake can reduce the risk of bone fractures. Most dietary vitamin D is obtained from fortified foods (Dietary Guidelines for Am ericans 2010). 1.2 Dietary Fiber vs. Added Fiber According to the Institut e of Medicine (2005) dietary fiber consists of nondigestible carbohydrates and lignin that are intrinsic and intact in plants. Added fiber consists of isolated, nondigestible carbohydrates that have beneficial physiological effects in humans. Total fiber is the sum of dietary fiber and add ed fiber (Institute of Medicine 2005 ). Dietary fiber is found naturally in foods such as fruits, vegetables, whole grains,
and beans. Dietary fiber may reduce the risk of coronary heart disease and some types of cancer ( Institute of Medicine, 2005) Added fiber may be isolated or extracted using chemical or enzymatic means (Institute of Medicine 2005 ) Added fiber includes synthetically manufactured and naturally occurring isolated oligosac charides (Institute of Medicine 2005 ). 1.3 Fiber Intake According to the 2007 2008 National Health and Nutrition Examination Survey (NHANES), the average dietary fiber intake of American m ales 20 years old and over is 17.7 g/day and the corresponding value for American females is 14.3 g /day. H owever, t he Dietary Reference Intake (DRI) for total fiber for 19 50 year old males is 38 g/day and is 25 g/day for females (Institute of Medicine 2005 ). Thus, American adults are only consuming about half of the recommended daily fiber intake. How ever, the average fiber intake may be slightly underestimated because added fibers such as inulin and oligofructose were not included in NHANES (International Food Information Council Foundation 2008). Foods in the U.S. food supply that have added fiber i nclude milk drinks, desserts, bakery products, meal replacers, bars, cereal, and ice cream (International Food Information Council Foundation 2008). Between the years 1995 and 2005, the available dietary fiber in the food supply was betwe en 24 and 25 g pe r capita (Fungwe et al. 2007). This might be enough to meet the DRI for adult females but is not enough to meet the DRI for adult m ales; therefore, additional added fiber may be needed in the food supply in order to help all adults meet the RDA
1.4 Inulin t ype Fructans Inulin, fructooligosaccharides, and oligofructose (collectively called inulin type fructans) are types of added fiber. Inulin generally has a degree of polymeri zation from 2 to 60 (Roberfroid 1999). Fructooligosaccharides and oligofructose ar e produced by partial enzymatic hydrolysis of inulin and have a degree of polymeri zation less than 10 (Roberfroid 1999). Oligofructose ty pically contains between 2 and 10 fructose units, while fructooligosaccharides usually have a degree of polymerization up to 5 ( Meyer and Stasse Wolthius 2009 ). The fructose units of inulin, fructooligosaccharides, and oligofructose are joined by (1,2) linkages (Stewart et al. 2008). This type of linkage is not hydrolyzed in the upper gastrointe stinal tract (Stewart et al. 2008). These fructans are, however, completely hydrolyzed and fermented in the colon by beneficial bacteria (Roberfroid 1999 ). This colonic fermentation produces short chain fatty acids (Nyman 2002). The short chain fatty acids that are mainly prod uced are acetic acid, propioni c acid, and butyric acid (Nyman 2002). Because inulin type fructans resist digestion in the upper part of the human gastrointestinal tract, they have a low calori c value for humans (Genta et al. 2009). Concentrated sources o f inulin type fructans include Jerusalem artichoke and chicory root (Stewart et al. 2008). Other sources include wheat, bananas, on ions, and garlic (Stewart et al. 2008). 1.5 Role of Fructans in Health 1.5.1 Prebiotic Effect Prebiotics are nondigestible oligosac charides that act as an energy source for beneficial bacteria in the colon, thus promoting their growth (Gibson et al. 2004)
Prebiotics are also considered to be fermentable fibers. Inulin type fructans have been shown to be effective prebiotics (Meyer a nd Stasse Wolthuis 2009) Lactobacilli and Bifidobacteria are beneficial bacteria in the colon (Meyer and Stasse Wolthuis 2009) A study done by Meyer and Stasse Wolthuis ( 2009 ) showed an increase in Bifidobacteria in adult participants after consumption of inulin or oligofructose from chicory. An i ncrease in Bifidobacteria improves the working of the intestine by producing short chain fatty acids, maintaining colonization resistance through competition with harmful bacteria for nutrients, and stimulatin g bowel motility (Meyer and Stasse Wolthuis, 2009) 1.5.2 Satiety and Decreased Energy Intake The fermentation of oligofructose into short chain fatty acids in the colon promotes the expression of the proglucagon gene in endocrine L cells that are locat ed in th e colon (Delzenne et al. 2007). This in turn stimulates the release of gastrointestinal peptides, including glucagon like peptide 1 (GLP 1), because they are derived from the expression of the p roglucagon gene (Delzenne et al. 2005). Release of GLP 1 enh ances satiety and decreases energy intake (Delzenne et al. 2007) A study done by Cani, Joly, Horsmans, and Delzenne ( 2006 ) found that feeding 16 grams of oligofructose per day for two weeks increases satiety following breakfast and dinner and reduces hun ger and prospective food consumption following dinner. This resulted in a 10% reduction in total energy intake. Inulin is not able to produce the same effects as oligofructose in terms of proglucagon gene expression and GLP 1 because inulin is fermented m ore distally in the colon, whereas oligofructose is fermented in the proximal colon (Cani et al. 2006).
Unlike oligofructose, inulin had no effect on satiety at breakfast in the study done by Cani et al. (2006). H owever, it was still able to induce a lowe r energy intake during the test day suggesting late post absorptive satiety triggers related to the absorption and metabolism of the short chain fatty acids produced when inulin is fermented in the colon. A stu dy done by Archer et al. ( 2004 ) demonstrated t hat inulin added to sausage patties as a fat replacer was able to lower energy intake during a test day. These studies demonstrate that consumption of foods with added inulin type fructans may increase satiety and, therefore, decrease energy intake. 1.5.3 Trea tment of Obesity In obesity, concentrations of GLP 1 and another gastrointestinal peptide, peptide YY, are reduced (Parnell and Reimer 2009) Peptide YY has effects similar to GLP 1. The low concentrations of these gastrointestinal peptides may promote fu rther development of obesity by making weight loss difficult (Parnell and Reimer 2009) Because oligofructose stimulates the release of GLP 1 and enhances satiety, oligofructose could be beneficial in preventing obesity or at least stopping further weight gain in obese individuals. In a study conducted by Parnell and Reimer ( 2009 ) overweight or obese subjects were given a daily supplement of 21 g oligofructose for three months. Due to the effect of oligofructose on satiety, there was a significant decreas e in energy intake in the oligofructose group compared to the placebo group. The results demonstrated that the oligofructose supplementation reduced body fat in the overweight and obese individuals. Therefore, oligofructose supplementation seems to be help ful in combatting obesity.
1.5.4 Increased Mineral Absorption A study conducted by Holloway et al. ( 2007 ) found that six weeks of treatment with 10 g/day of a product containing oligofructose from chicory root plus long chain inulin enriched with oligofructose in postmenopausal women resulted in a significant increase in both calcium and magnesium absorption relative to the placebo treatment. The increase in calcium absorption is due to the production of short chain fatty acids by inulin type fructans. Short ch ain fatty acids may increase transcellular transport of calcium by decreasing pH, which all ows for additional exchange of hydrogen ions for calcium ions (Holloway et al. 2007). Another study determined that young adults supplemented with 8 g/day of an inu lin type fructan had an additional 30 mg of daily calcium accretion to the skeleton compared to the placebo g roup (Abrams et al. 2007). This illustrates that consumption of inulin type fructans may help prevent osteoporosis. 1.5 Study Objective and Hyp othesis Although studies have demonstrated that consumption of foods with adde d inulin type fructans may increase satiety, there have been no long term studies of the effect of inulin type fructans on nutrient intake in humans. Specifically there have bee n no studies that have examined how incorporating foods with these added fibers into a regular diet alters the micronutrient content within the diet. Therefore, the objective of this study was to examine the effect of daily consumption of a snack bar and y ogurt containing a total of 16 g o f oligorfructose versus control on the micronutrient content within the diet. Specifically, what is the effect of the consumption of the added fiber oligofructose on the intake of the nutrients of concern ( fiber, potassium calcium, vitamin D, and sodium)?
Do es consuming foods with added oligofructose help individ uals meet the recommended intakes for these nutrients? Section 2: Materials and Methods 2.1 Participants Eligible participants were healthy adults between the ag es of eighteen and fifty years old with a BMI of 23.0 to < 30 kg/m 2 and a usual fiber intake of < 20 g/day as determined by the Fruit/Vegetable/Fiber Screener (Appendix 1 ). A ddi tionally, participants were required to have internet access for the duration o f the study have normal eating behaviors as determined by the Eating Inventory (Appendix 2 ), be weight stable ( 5 lbs. for the past 3 months), be willing to eat yogurt and a granola like snack bar daily for 8 weeks, be willing to complete daily questionn aires (Appendix 3) and 28 dietary recalls over approximately 10 weeks, and be a habitual breakfast consumer (defined as eating any food within 2 hours of waking, 5 or more days a week) in order to be included in the study. Participants who were post menop ausal (no mens trual period for one year), were lactating or pregnant, were curren t smokers or tobacco users, use d antibiotics withi n two months of study start, had known food allergies, had disordered eating behaviors as determ ined by the Eating Inventory, were unwilling to discontinue any prebiotic and fiber suppleme n ts or probiotic supplement, had a physician diagnosed gastrointestinal disease or condition (other than GERD, constipation or diverticular disease), took prescribed medications (other than or al contraceptives, seasonal allergy medications, cholesterol or blood pressure lowering medications, vitamins or mine rals, or baby aspirin), consume d
greater than two alcoholic drinks per day on average or exercise d more than three hundred minutes per week on average were excluded from the study. Based on the Automated Self Administered Diet History (ASA24) (Appendix 4), participant s who ate less than 1200 kcal/day if female or less than 1500 kcal/day if male or who ate more th an 4000 kcal/day or who cons ume d greater than 1 0 g dietary fiber/1000 kcal were also excluded from the study. 2.2 Consent and Pre baseline Data Partic ipants were recruited for the study th r ough flyers (Appendix 5) that were handed out around the University of Florida campus and by announcements made about the stu dy. Interested participants were instructed to contact the study coordinators. A total of 207 participants consented for the study Pre baseline data was collected from the participants after consent. The anthropometric d ata collected was height (cm), weight (kg), and Body Mass Index (BMI). Additionally, the participants complete d 24 hour dietary recalls for 7 days over 1 week using the ASA24 sys tem. Participants also complete d the Eating Inventory questionnaire and the Gl obal Physical Activity Questionnaire (GPAQ) (Appendix 6 ). Ninety eight of the 207 participants who consented met the inclusion/exclusion criteria and were randomized. 2.3 Randomization The study was a randomized, double blind, paral lel arm study. Particip ants were randomized in blocks with blocks being three different calorie ranges for males and
females (i.e., six different blocks) based on pre baseline energy in take. The calorie ranges were determined prior to rando mization. Participants wer e then either assigned to the treatment group and incorporate d yogurt and snack bars containing 16 g of oligofructose into their usual diet or th e control group and incorporate d similar snack foods without the added fiber into the ir usual diet. General Mills, Inc. and Sensus America, Inc. provided the snack bars and yogurt. The yogurt containing 8 g of oligofructose was six ounces and had 109.5 calories, 0.19 g fat, 12.14 g sugar, 8.45 g fiber, and 6.86 g protein. The placebo yogurt was six ounces and had 106.7 calories 0.19 g fat, 14.86 g sugar, 0.048 g fiber, and 6.78 g protein The snack bar containing 8 g of oligofructose contained 148 calories, 1.4 g fat, 8.8 g fiber, and 1.51 g protein. The placebo snack bar contained 143 calories, 1.0 g fat, 0.5 g fiber, and 1.5 g protein (Appendix 7). Participants were randomized over a 7 day period 2.4 Study Protocol Participants were informed of the study protocol at the beginning of the stu dy. Each participant was counseled on how to substitute study foods into their usual diet and instructed on portion sizes using f o od models. Each participant was also counseled on the importance of maintenance of activity and completion of daily food recor ds. Participants were then provided with a schedule for diet recalls, appetite reco rds, food pick up, etc. Particip ants in the treatment group were given about 8 g/d of oligofructose incorporated into granola type sna ck bars or yogurt that they were asked to consume along with their usual diet for the firs t week. For weeks 2 8, they wer e given two servin gs per day (16 g) and asked to consume them along with their usual diet. Partic ipant s in the
control group were given a similar snack bar or yogurt withou t the added fiber and the same instructions. Participants were required to complete a daily questionnaire recording study food intake. Onl ine 24 hour dietary recalls were required for seven days in a row at weeks 4, 6, and 8 via the ASA24 system. Participants who completed less than 3 ASA24 dietary recalls on weeks 4, 6, or 8 were exclud ed from the study. Participants who started antibiotics during the study were also excluded from the study and all of their ASA24 data post antibiotic therapy was deleted. Participants were contacted on a regular basis in order to check on their progress a nd to remind them of upcoming study procedures. Complian ce t o eating the study foods was determined by the daily ques tio nnaire that participants were required to fill out each day. Ninety three of the 98 participants who were randomized were compliant and completed the study. At the completion of the study, par ticipants were asked to return for a final clinical visit. End o f st udy anthropometrics data was collected including weight and waist circumferenc e Participants also complete d the Eating Inventory q uestionnaire, the Global Physical Activity Questionnaire, and a five question final questionnaire (Appendix 8 ) at their final visit. Addit io nally, participants were asked to return unused study foods and to indicate whether they thought they were in the tr eatment group or control group. The 24 hour dietary recalls taken at weeks 4, 6, and 8 from the treatment group were compared to the 24 hour dietary recalls of the control group in order to determine how fiber, potassium, calcium, and sodium intake (ASA24 system d id not give vitamin D intake) within the diet was affected by the addition of 16 g of oligofructose into the usual
diet. Additionally, the 24 hour dietary recalls taken at weeks 4, 6 and 8 were compared to the baseline 24 hour dietary recalls in o rder to examine any differences in fiber, potassium, calcium, and sodium intake. Study data was analyzed as intent to treat and as greater than or equal to 75% compliance of study foods (1.5 servings of study food each day ). Section 3: Results 3.1 Statis tical Analysis The fiber intake s from all the ASA24 s completed by a participant during baseline were averaged. An average was found for each nutrient of concern for each participant based off of the ASA24s that they completed during baseline. The baseline averages recorded for each nutrient in Table 2 and Table 3 were found by averaging all the participants' ( in the treatment group or control group ) individual baseline nutrient averages. The averages for the treatment period (weeks 4, 6, and 8) were d et ermi ned by averaging the fiber intakes recorded by the ASA24s completed by a participant during the treatment period and then taking the average of all the participants' ( in the treatment group or control group ) individual treatment averages. The averages for total fiber were found by adding the fiber content of the study foods to the fiber intakes reported by the ASA24. The ASA24 does not have an option to record that the study food was eaten; therefore, the fiber intake reported by the ASA24 does not reflect the added fiber from the study food. The daily questionnaire was used to determine how much of the study food each participant ate each day and, therefore, how much added fiber they consumed.
A T test was performed using Excel in order to find the p value s and determine statistical differences. 3.2 Comparison of Treatment Group and Control Group F iber intake as reported by the ASA24 calcium intake, potassium intake, and sodium intake were not significantly different between the treat ment group consuming 16 g oligofructose /day and the control group (Table 1 ). When looking at total fiber intake, the group consuming oligofructose had a significantly higher intake than the control group (24.3 g compared to 9.4 g per day ). 3.3 Comparison of Baseline and Tr eatment Period for the Treatment Group F iber intake as reported by the ASA24 was not significantly different between baseline and the treatmen t period for the group consuming oligofructose (Table 2). When looking at total fiber intake, fiber intake increas ed sign ificantly from baseline upon oligofructose supplementation ( 12.1 g to 24.3 g). Calcium (P = 3.5 5 x 10 7 ) and potassium (P = 0.001 ) intakes significantly increased. Sodium intake significantly decreased upon treatment with oligofructose (P = 0.04 1 ). 3.4 Comparison of Baseline and Treatment Period for the Control Group F iber intake as reported by the ASA24 decreased from baseline to the treatment period for the control group (P = 0.028) (Table 3). Total fiber also decreased from baseline to treatment (13 g to 9.4 g). Calcium (P = 1.95 x 10 5 ) and potassium (P = 0.007) intakes significantly increased Sodium intake was not significantly different.
Section 4: Discussion Base d on the results of this study, individuals who consume foods such as granola bars and yogurt, with added oligofructose are more likel y to meet the recommended intake for fiber Consuming 16 g oligofructose resulted in an average total fiber intake of 24.3 g. This is close to the recommended intake of 25 g for females. If individu als consume healthy foods, such as yogurt, that have added fiber, they can significantly increase their potassium and calcium intake. It is not the oligofructose itself that causes potassium and calcium intake to increase, but the yogurt that the oligofruc tose is added to. The results indicate that eating healthy foods with added fiber that contain potassium and calcium will help individuals meet the RDA for them. ASA24 does not provide data for vitamin D, but it can be speculated that with vitamin D fortif ied yogurt vitamin D intake will increase as well. T he only other effect the oligofructose seemed to have besides increasing fiber intake was slightly decreasing the sodium intake compared to the baseline sodium intake in the i ndividuals consuming 16 g ol igofructose a day The results of this study as far as fiber intake is concerned are consistent with the findings of a study done by Cani, Joly, Horsmans, and Delzenne (2006) that found that daily supplementation of 16 g of oligofructose increased daily total fiber intake by an average of 16 g. Based on the research, i t can be concluded that added fiber does help individuals meet the daily recommended intake for fibe r. There have not been any other studies done that have examined the relationship between added fiber and the other nutrients of concern. Another study should be done before concluding that sodium intake will decrease in individuals that start consuming foo ds with added oligofructose.
Literature Cited Abrams SA, Griffin IJ, Hawthorne KM. 2007. Young adolescents who respond to an inulin type fructan substantially increase total absorbed calcium and daily calcium accretion to the skeleton. J Nut r 137(11 Suppl):2524S 2526S. Archer BJ, Johnson SK, Devereux HM, Baxter AL. 2004. Effect of fat replacement by inulin or lupin kernel fibre on sausage patty acceptability, post meal perceptions of satiety and food intake in men. Br J Nutr 91(4):591 9. Ca ni PD, Joly E, Horsmans Y, Delzenne NM. 2006. Oligofructose promotes satiety in healthy human: a pilot study. Eur J Clin Nutr 60(5):567 72. Delzenne NM, Cani PD, Daubioul C, Neyrinck AM. 2005. Impact of inulin and oligofructose on gastrointestinal peptide s. Br J Nutr 93 Suppl 1:S157 61. Delzenne NM, Cani PD, Neyrinck AM. 2007. Modulation of glucagon like peptide 1 and energy metabolism by inulin and oligofructose: experimental data. J Nutr 137(11 Suppl):2547S 2551S. Fungwe TV, Bente L, Hiza H 2007. The food supply and dietary fiber: its availability and effect on health. USDA Center for Nutrition Policy and Promotion. Genta S, Cabrera W, Habib N, Pons J, Carillo IM, Grau A, S nchez S. 2009. Yacon syrup: beneficial effects on obesity and insulin resista nce in humans. Clin Nutr 28(2):182 7. Gibson GR, Probert HM, Loo JV, Rastall RA, Roberfroid MB. 2004. Dietary modulation of the human colonic microbiota: updating the concept of prebiotics. Nutr Res Rev 17(2):259 75. Holloway L, Moynihan S, Abrams SA, Ke nt K, Hsu AR, Friedlander AL. 2007. Effects of oligofructose enriched inulin on intestinal absorption of calcium and magnesium and bone turnover markers in postmenopausal women. Br J Nutr 97(2):365 72. International Food Information Council Foundation. 20 08. Fiber fact sheet. Institute of Medicine, Food and Nutrition Board. 2005. Dietary Reference Intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein, and amino acids, pp. 339 421. The National Academies Press, Washington, D.C. M eyer D, Stasse Wolthuis M. 2009. The bifidogenic effect of inulin and oligofructose and its consequences for gut health. Eur J Clin Nutr 63(11):1277 89. National Center for Health Statistics. 2007 2008. National Health and Nutrition Examination Survey (NH ANES).
Nyman M. 2002. Fermentation and bulking capacity of indigestible carbohydrates: the case of inulin and oligofructose. Br J Nutr 87 Suppl 2:S163 8. Parnell JA, Reimer RA. 2009. Weight loss during oligofructose supplementation is associated with dec reased ghrelin and increased peptide YY in overweight and obese adults. Am J Clin Nutr 89(6):1751 9. Roberfroid MB. 1999. Caloric value of inulin and oligofructose. J Nutr 129(7 Suppl):1436S 7S. Stewart ML, Timm DA, Slavin JL. 2008. Fructooligosaccharide s exhibit more rapid fermentation than long chain inulin in an in vitro fermentation system. Nutr Res 28(5):329 34. U.S. Department of Agriculture and U.S. Department of Health and Human Services. December 2010. Dietary Guidelines for Americans, 2010 7 th Edition. U.S. Government Printing Office, Washington, D.C.
Tables Table 1. Average nutrient intakes collected using the ASA24 system during weeks 4, 6, and 8 for the treatment group and control group. Oligofructose n = 48 Control n = 45 P value Total Fiber (g) 24.3 0.5 9.4 0.6 P < 0.001 Fiber (g) 11.5 0.5 11.6 0. 5 NS Calcium (mg) 997 37 1057 50 NS Potassium (mg) 2315 8 0 2428 92 NS Sodium (mg) 3068 108 3282 142 NS Results are mean standard error; statis tical analysi s performed through an unpaired two tailed t test. Table 2. Nutrient intakes for the treatment group collected using the ASA24 system during baseline and the treatment period (weeks 4, 6, and 8). Baseline n = 48 Treatment Period n = 48 P value Total Fiber (g) 12.1 0.5 24.3 0.5 P < 0.001 Fiber (g) 12 .1 0.5 11.5 0.5 NS Calcium (mg) 800 41 997 37 P < 0.001 Potassium (mg) 2065 84 2315 8 0 P < 0.001 Sodium (mg) 3266 130 3068 108 P < 0.05 Results are mean standa rd error; statistical analysi s performed through a paired two tailed t test. Table 3. Nutrient intakes for the control group collected using the ASA24 system during baseline and the treatment period (weeks 4, 6, and 8). Baseline n = 45 Treatment Period n = 45 P value Total Fiber (g) 13 .0 0.5 9.4 0.6 P < 0.001 Fiber (g) 12.7 0.5 11.6 0. 5 P < 0.05 Calcium (mg) 863 49 1057 50 P < 0.001 Potassium (mg) 2221 110 242 8 92 P < 0.01 Sodium (mg) 3308 150 3282 142 NS Results are mean s tandard error; statistical analysi s performed through a paired two tailed t test.
Appendix 1 Fruit/Vegetable/Fiber Screener Your Name (optional): Age: Sex: Male Female Think about your eating habits over the past year or so. About how often do you eat each of the following foods? Remember breakfast, lunch, dinner, snacks and eating out. Check one radio button for each food. Fruits, Vegetables, and Grains Less than 1/WEEK Once a WEEK 2 3 times a WEEK 4 6 times a WEEK Once a DAY 2+ a DAY Fruit juice, like orange, apple, grape, fresh, frozen or canned. (Not sodas or other drinks) How often do you eat any fruit, fresh or canned (not counting juice?) Vegetable juice, like tomato juice, V 8, carrot Green salad Potatoes, any kind, including baked, mashed or french fried Vegetable soup, or stew with vegetables Any other vegetables, including string beans, peas, corn, broccoli or any other kind Fiber cereals like Raisin Bran, Shredded Wheat or Fruit n Fiber Beans such as baked beans, pinto, kidney, or lentils (not green beans) Dark bread such as whole wheat or rye
Appendix 3 Daily Questionnaire Did you experience any of the following gastrointestinal side effects in the last 24 hours since you consumed the test product? Please circle one choice 0 10, 0= none, 5= mild, 10= very severe. Note: If you are a female, please do not rate menstrual crampin g and bloating. Bloating Please rate the severity by circling the appropriate number below 0 1 2 3 4 5 6 7 8 9 10 None mild very severe Flatulence Please rate the severity by circling the appropriate numb er below 0 1 2 3 4 5 6 7 8 9 10 None mild very severe Abdominal Cramping Please rate the severity by circling the appropriate number below 0 1 2 3 4 5 6 7 8 9 10 None mild very severe Stomach Noises Please rate the severity by circling the appropriate number below 0 1 2 3 4 5 6 7 8 9 10 None mild very severe How many stools (bowel movements) did you have today? ___ ___________ 0 1 2 3 4 5 6 7 8 9 10 >10 How many hours did you sleep last night? Do not include the time it took you to fall asleep or anytime you were awakened during the night. Circle the time that most closely matches your sleep. <5 hours 5 6 ho urs 6 7 hours 7 8 hours 8 9 hours >9 hours
How many study yogurts did you eat today? 0 # 1 1 # 2 How many study snack bars did you eat today? 0 # 1 1 # 2 Did you visit a doctor today? Yes No Did you take an antibiotic today? Yes No !
Appendix 4 Dietary intake will be assessed using the ASA24. The ASA24 is a web based 24 hour dietary recall hosted by the National Cancer Institute. The investigators will provide subject study numbers (i.e., not names or other identifying information ) to the ASA24 developers. The developers will then assign a password for each study number. Subjects will access the ASA24 using their study number and password. The investigators can monitor subject progress and download nutrient intake estimates. Qu estions on the ASA24 include when did you eat, what did you eat, and how much did you eat. !
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Appendix 7 Yogurt Active (8 g oligofructose) Placebo Serving size 6 oz 6 oz Calories 109.5 106.7 Fat 0.19 g 0.19 g Carbohydrates 24.23 g 19.49 g Sugar 12.14 g 14.86 g Fiber 8.45 g 0.048 g Protein 6.86 g 6.78 g Snack Bar Fiber (8 g oligofructose) Placebo Calories 148 143 Fat 1.4 g 1.0 g Carbohydrates 32.6 g 31.8 g Fiber 8.8 g 0.5 g Protein 1.51 g 1.5 g
Appendix 8 Final Data Collection Sheet Subject Number: ________ Date: __________ Height ________cm Weight ________kg BMI ___________ Waist Circumference_______________ For the participant to fill out: Which study group do you thi nk you were in? Fiber supplemented group Non fiber supplemented group Why? Where you recently diagnosed with any gastrointestinal diseases or conditions? Yes No If so, what? Did you begin taking any medications or dietary supplements over the course of t he study? Yes No If so, what? Did your alcohol intake change over the study? Yes No If so, how? Women: Are you pregnant? Yes No