Elucidating the Effect of Dietary Stearic Acid on the Regional Heterogeneity of the Gut Microbiome and Metabolome: Focus on Bile Acid Metabolism (SAMPill Study)

ConditionCVD Risk
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorTufts University

About this trial

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.

Eligibility criteria

Qualifiers

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

Age >50 years

BMI >20 to <35 kg/m2, inclusive

Non-smoker or former smoker who quit > 6 months

Disqualifiers

Allergy/intolerance/religious reasons to avoid study meals or food ingredients

Regular use of dietary supplements, pre/probiotics, laxatives or fiber supplements (except multivitamins) within the past 3 months

Use of steroids (excluding topical) within the past 3 months

Regular use of aspirin (except baby aspirin), NSAIDS, or anti diarrheal medication

Trial design

Treatments tested in this trial

  • High Palmitic Acid Diet
  • High Stearic Acid Diet

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators