[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100409417":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":64,"collaborators":24,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":24,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Missouri-Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High Fiber diet","EXPERIMENTAL","Group receiving a high fiber diet",[13],"Other: Dietary fiber: 10-25g",{"label":15,"type":6,"description":16,"interventionNames":17},"Low Fiber diet","Control group receiving a low fiber diet",[18],"Other: Dietary fiber: 5g",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Dietary fiber: 10-25g","10-25 g\u002Fday of fiber",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Dietary fiber: 5g","5 g\u002Fday of fiber",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Katherene OB Anguah, PhD","CONTACT","(573)-882-8966","anguahk@missouri.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Columbia","Missouri","65212","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-92.33407,38.95171,{"lat":47,"lon":46},[50,54,56,59,62],{"name":51,"role":32,"phone":52,"phoneExt":53,"email":34},"Katherene O Anguah, Ph.D","573-882-8966","5738828966",{"name":55,"role":32,"phone":53,"phoneExt":53,"email":34},"Katherene O Anguah",{"name":57,"role":58,"phone":24,"phoneExt":24,"email":24},"Katherene O Anguah, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":60,"role":61,"phone":24,"phoneExt":24,"email":24},"Elizabeth J Parks, Ph.D.","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":24,"phoneExt":24,"email":24},"Shawn Christ, Ph.D.",{"type":58,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Katherene Anguah","Assistant Professor, Nutrition & Exercise Phys-HES","100409417","dietary-fiber-effects-on-the-microbiome-and-satiety-100409417",false,"NCT04611217","Dietary Fiber Effects on the Microbiome and Satiety","Mechanisms Linking Dietary Fiber, the Microbiome and Satiety","FEMS","Inclusion Criteria:\n\n* Men and women (premenopausal only)\n* Age 20-55y (Aim 1); 45-55y (Aim 2)\n* BMI ≥25 or ≤35 kg\u002Fm2 (Aim 1); ≥25 or ≤40 (Aim 2)\n* Weight stable (no fluctuations in body weight of greater than 4 kg in the last 3 months)\n* Willing to consume a research diet\n* Willing to provide blood and fecal samples\n* At least one characteristic of the metabolic syndrome (but not diabetic)\n\n  1\\. A large waistline: 35 inches or more for women 40 inches or more for men 2. High triglycerides: 150 mg\u002FdL or higher 3. Low HDLc level: \\\u003C50 mg\u002FdL for women \\\u003C40 mg\u002FdL for men 4. High blood pressure ≥130\u002F85 mmHg 5. Fasting blood sugar ≥100 mg\u002FdL\n* Pre-diabetes acceptable (glucose \\\u003C125 mg\u002FdL or HbA1c \\\u003C6.5%)\n* Stably treated with statin drugs, anti-hypertensives, and anti-depressants. These are acceptable as long as the drug category does not alter appetite, body weight, or the microbiome (if known)\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Postmenopausal (evidence suggests an interplay between the gut microbiome)\n* BMI of \\\u003C25 or \\>35 kg\u002Fm2 (Aim 1); \\\u003C25 or \\>40 kg\u002Fm2 (Aim 2)\n* Use of medications that affect the gut microbiome (e.g. antibiotics)\n* Taking medications known to affect appetite (e.g., phentermine) or gastrointestinal function (e.g., metformin)\n* On a special diet or undergoing weight loss, vegetarian, or other restricted dietary patterns\n* Ad libitum intake of fiber above 25g\u002Fday (mean intake in the US population is 17g\u002Fday) and \\\u003C 10g\u002Fd\n* Ad libitum alcohol intake of greater than 1 drink\u002Fd for women and 2 drinks\u002Fd for men\n* History of disease (example colon cancer, HIV, cardiovascular disease, psychiatric disorders, etc.)\n* Use of tobacco products\n* Having metal or implants in the body that are not MRI compatible (Aim 1 only)",true,"ALL","20 Years","55 Years",{"count":80,"type":81},88,"ESTIMATED","INTERVENTIONAL",[84],"NA","Strong evidence supports the association between high fiber (HiFi) diets (e.g. legumes, nuts, vegetables) and a reduced risk for chronic conditions such as cardiovascular disease (CVD), type 2 diabetes and some forms of cancer. However, the current U.S. average consumption of dietary fiber of 17g\u002Fday is significantly below the recommendation level of 25g\u002Fd for women and 38g\u002Fd for men. Furthermore, fiber fermentation to produce short chain fatty acid (SCFA) products and alterations in microbial composition and activity may be mechanisms linking a HiFi diet to improved health. Importantly, much of the data, including findings supporting a beneficial role of SCFA have been derived from animal studies. Human studies are now needed to advance the understanding of the translational significance of rodent studies and the potential benefit of fiber on microbial metabolites and cardiometabolic health, glucose regulation, appetite and satiety. The central hypothesis is that that the mechanisms by which dietary fiber provides metabolic benefit include direct physical effects in the upper gastrointestinal tract to slow nutrient absorption, and indirect effects to reduce food intake mediated by SCFA-induced secretion of intestinal hormones resulting in increased satiety. Design: Using fiber derived from peas, Aim 1 will test the effect of a HiFi diet on appetite, satiety, and cardiometabolic health and whether elevated SCFA concentration mediates improved satiety in 44 overweight\u002Fobese subjects randomly assigned to receive either a high fiber or a low fiber dietary intervention for four weeks in a parallel arm-repeated measures design. Aim 2 will quantitate the changes in microbial composition and colonic SCFA production rate during HiFi feeding and whether any changes are potential mediators of observed benefits on satiety and cardiometabolic risk factors in 26 subjects assigned to receive a high fiber intervention for 3 weeks in a repeated measures design. Relevance: These studies will significantly expand the understanding of mechanisms by which dietary fiber improves satiety and cardiometabolic health in humans.",[87],"Dietary Fiber",[89,90,91,92,93,94],"dietary fiber","satiety","microbiome","short chain fatty acids","functional magnetic resonance imaging","cardiometabolic risk","2025-06-20",{"date":97,"type":98},"2025-06-22","ACTUAL",{"date":100,"type":98},"2021-04-22",{"date":102,"type":81},"2025-08-01",{"name":5,"class":6},1]