[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652074":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":45,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":20,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":75,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Tufts University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Palmitic Acid Run-In Followed by Stearic Acid Diet","EXPERIMENTAL","A controlled 38-day intervention with a10 day run-in phase with a diet high in palmitic acid to stabilize baseline variables, followed by a 28 diet phase with a diet high in stearic acid",[13,14],"Other: High Palmitic Acid Diet","Other: High Stearic Acid Diet",[16,21],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"High Palmitic Acid Diet","The main source of palmitic acid that will be used to prepare the meals will include blends of palm oil and safflower oil, which are commercially available. These blends will be incorporated into foods such as muffins, cookies, sauces, and mixed dishes (e.g., casseroles).",[9],null,{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"High Stearic Acid Diet","The main source of stearic acid that will be used to prepare the meals will include blends of cocoa butter, fully hydrogenated soybean and safflower oil, all of which are commercially available. These blends will be incorporated into foods such as muffins, cookies, sauces, and mixed dishes (e.g., casseroles).",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Nirupa R Matthan, PhD","CONTACT","6175563114","nirupa.matthan@tufts.edu",[32],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":20},"Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University","Boston","Massachusetts","02111","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-71.05977,42.35843,{"lat":43,"lon":42},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Nirupa Matthan","Scientist 1\u002FAssociate Professor","100652074","elucidating-the-effect-of-dietary-stearic-acid-on-the-regional-heterogeneity-of-the-gut-microbiome-and-metabolome-focus-on-bile-acid-metabolism-sampill-study-100652074",false,"NCT07766915","Elucidating the Effect of Dietary Stearic Acid on the Regional Heterogeneity of the Gut Microbiome and Metabolome: Focus on Bile Acid Metabolism (SAMPill Study)","Elucidating the Effect of Dietary Stearic Acid on the Regional Heterogeneity of the Gut Microbiome and Metabolome: Focus on Bile Acid Metabolism","SAMPill","Inclusion Criteria:\n\n1. Postmenopausal women (defined as complete natural cessation of menses for \\>12 months or a bilateral oophorectomy), who are not currently using hormone replacement therapy (HRT) or gender-affirming hormone treatments\n2. Age \\>50 years\n3. BMI \\>20 to \\\u003C35 kg\u002Fm2, inclusive\n4. Non-smoker or former smoker who quit \\> 6 months\n5. Normotensive with or without medication\n6. Normal gastrointestinal function with regular bowel movements at least once every other day\n7. Willingness to swallow the mini-pills\n8. Willingness to collect and return multiple stool samples\n9. Adequate refrigerator and freezer space to store study meals\n10. Intent to remain in the greater Boston area during the intervention periods\n\nExclusion Criteria:\n\n1. Allergy\u002Fintolerance\u002Freligious reasons to avoid study meals or food ingredients\n2. Regular use of dietary supplements, pre\u002Fprobiotics, laxatives or fiber supplements (except multivitamins) within the past 3 months\n3. Use of steroids (excluding topical) within the past 3 months\n4. Regular use of aspirin (except baby aspirin), NSAIDS, or anti diarrheal medication\n5. Current smokers or former smokers who quit \\\u003C 6 months ago, and use of nicotine replacement products within the last 6 months\n6. Chronic constipation\n7. Use of oral antibiotics within the past 3 months.\n8. Use of dental prophylaxis within the past 3 months\n9. Regular use of stomach acid lowering and weight loss medications such as GLP-1 agonists\n10. Planned colonoscopy 3 months prior to or during the study period\n11. Swallowing disorder or inability or difficulty taking pills\n12. Malabsorptive and inflammatory bowel disease, diverticulosis, and history of diverticulitis, gastric esophageal\u002Fintestinal surgery, including lap banding or bariatric surgery.\n13. History of bowel obstruction, gallstones, gastroparesis, pancreas and liver\u002Fgallbaldder disorders.\n14. Any form of active substance abuse or dependence (including drug or alcohol abuse).\n15. Established major chronic diseases such as CVD, diabetes, active cancer within the last 5 years, or any significant medical condition at the study MD's discretion\n16. A clinical condition that, in the judgment of the study MD or PI, could potentially pose a health risk to the subject while involved in the study.\n17. Unwillingness to adhere to study protocol\n18. Intent to increase or decrease body weight during the study period\n19. No Social Security number (for payment and IRS forms).\n20. Individuals who directly report to any member of the research team.","FEMALE","50 Years",{"count":60,"type":61},20,"ESTIMATED","INTERVENTIONAL",[64],"NA","Stearic acid and palmitic acid are two common consumed saturated fatty acids found in foods. Palmitic acid is associated with increases in blood cholesterol, whereas stearic acid is generally considered neutral with respect to blood cholesterol. However, the mechanisms underlying these different effects are not fully understood. The goal of this clinical trial is to determine how replacing dietary palmitic acid with stearic acid affects microorganisms living in the gastrointestinal tract (gut microbiome) and the metabolites they produce, including secondary bile acids, and whether these changes influence heart and metabolic health in postmenopausal women. The main question it aims to answer is whether the cholesterol lowering effect of dietary stearic acid, compared to dietary palmitic acid is due to changes in the composition and function of the gut microbiome and bile acid metabolism. Participants will consume a controlled diet high in palmitic acid for a 10-day run-in period, followed by a controlled diet high in stearic acid for 28 days. During the study, participants will provide biological samples, including blood samples collected in both fasting and non-fasting states, for assessment of cardiometabolic outcomes. Participants will also swallow mini-pills designed to collect samples from different regions of the gastrointestinal tract to assess the gut microbiome and related metabolites. Results will contribute to understanding the relationship between stearic acid mediated microbiota effects on cardiometabolic heath.",[67],"CVD Risk",[69,70,71,72,73,74],"stearic acid","bile acid metabolism","post-menopausal women","dietary intervention","saturated fatty acids","gut microbiome","NOT_YET_RECRUITING","2026-08-11",{"date":78,"type":79},"2026-08-17","ACTUAL",{"date":81,"type":61},"2026-09",{"date":83,"type":61},"2029-08",{"name":5,"class":6},1]