Stearic Acid Diet for Cardiovascular Health

(SAMPill Trial)

NR
Overseen ByNirupa R Matthan, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Tufts University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for postmenopausal women interested in how diet affects heart and metabolic health. Participants should be generally healthy, able to follow a controlled diet, and willing to provide blood and gut samples. Specific inclusion or exclusion criteria are not detailed here.

Inclusion Criteria

My digestion is normal and I have bowel movements at least every other day.
Willingness to swallow the mini-pills
Willingness to collect and return multiple stool samples
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Exclusion Criteria

I have a history of digestive or gallbladder problems.
Current smokers or former smokers who quit <6 months ago, and use of nicotine replacement products within the last 6 months
I regularly take aspirin, NSAIDs, or anti-diarrheal medicine.
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What Are the Treatments Tested in This Trial?

Trial Overview

The study compares the effects of two diets: one high in palmitic acid (for 10 days) followed by one high in stearic acid (for 28 days). Researchers will analyze changes in gut bacteria, bile acids, and markers of heart health using blood tests and special pills that collect gut samples.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Palmitic Acid Run-In Followed by Stearic Acid DietExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials
271
Recruited
595,000+