Could a simple fat swap reshape your gut bacteria and protect your heart?

NCT ID NCT07766915

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This study tests whether replacing palmitic acid (a saturated fat that raises cholesterol) with stearic acid (a cholesterol-neutral fat) in the diet changes the gut microbiome and bile acid metabolism, and whether these changes explain stearic acid's heart benefits. Postmenopausal women will follow a controlled diet high in palmitic acid for 10 days, then switch to a high-stearic-acid diet for 28 days. Researchers will collect blood, stool, and gut samples using special mini-pills to measure microbes and bile acids across different gut regions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A controlled diet high in stearic acid, compared with a diet high in palmitic acid
What this could lead to
If stearic acid's cholesterol-neutral effect works through the gut microbiome, it could point to dietary or probiotic strategies for heart health.
What could go wrong
This is a small, early-stage study in a specific group (postmenopausal women), so findings may not apply broadly. The effect may also be too subtle to change clinical advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 2. Age \>50 years 3. BMI \>20 to \<35 kg/m2, inclusive 4. Non-smoker or former smoker who quit \> 6 months 5. Normotensive with or without medication 6. Normal gastrointestinal function with regular bowel movements at least once every other day 7. Willingness to swallow the mini-pills 8. Willingness to collect and return multiple stool samples 9. Adequate refrigerator and freezer space to store study meals 10. Intent to remain in the greater Boston area during the intervention periods Exclusion Criteria: 1. Allergy/intolerance/religious reasons to avoid study meals or food ingredients 2. Regular use of dietary supplements, pre/probiotics, laxatives or fiber supplements (except multivitamins) within the past 3 months 3. Use of steroids (excluding topical) within the past 3 months 4. Regular use of aspirin (except baby aspirin), NSAIDS, or anti diarrheal medication 5. Current smokers or former smokers who quit \< 6 months ago, and use of nicotine replacement products within the last 6 months 6. Chronic constipation 7. Use of oral antibiotics within the past 3 months. 8. Use of dental prophylaxis within the past 3 months 9. Regular use of stomach acid lowering and weight loss medications such as GLP-1 agonists 10. Planned colonoscopy 3 months prior to or during the study period 11. Swallowing disorder or inability or difficulty taking pills 12. Malabsorptive and inflammatory bowel disease, diverticulosis, and history of diverticulitis, gastric esophageal/intestinal surgery, including lap banding or bariatric surgery. 13. History of bowel obstruction, gallstones, gastroparesis, pancreas and liver/gallbaldder disorders. 14. Any form of active substance abuse or dependence (including drug or alcohol abuse). 15. 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 16. 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. 17. Unwillingness to adhere to study protocol 18. Intent to increase or decrease body weight during the study period 19. No Social Security number (for payment and IRS forms). 20. Individuals who directly report to any member of the research team.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University

    Boston, Massachusetts, 02111, United States

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