CVD RiskSAMPillNCT07766915
Elucidating the Effect of Dietary Stearic Acid on the Regional Heterogeneity of the Gut Microbiome and Metabolome: Focus on Bile Acid Metabolism (SAMPill Study)
A study testing High Palmitic Acid Diet and High Stearic Acid Diet in people with CVD Risk, run by Tufts University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- CVD Risk
- What is being tested?
- High Palmitic Acid Diet and High Stearic Acid Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Normotensive with or without medication
- Normal gastrointestinal function with regular bowel movements at least once every other day
Show all 10Show fewer
- Willingness to swallow the mini-pills
- Willingness to collect and return multiple stool samples
- Adequate refrigerator and freezer space to store study meals
- Intent to remain in the greater Boston area during the intervention periods
Who cannot join
- 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
- Current smokers or former smokers who quit < 6 months ago, and use of nicotine replacement products within the last 6 months
- Chronic constipation
Show all 20Show fewer
- Use of oral antibiotics within the past 3 months.
- Use of dental prophylaxis within the past 3 months
- Regular use of stomach acid lowering and weight loss medications such as GLP-1 agonists
- Planned colonoscopy 3 months prior to or during the study period
- Swallowing disorder or inability or difficulty taking pills
- Malabsorptive and inflammatory bowel disease, diverticulosis, and history of diverticulitis, gastric esophageal/intestinal surgery, including lap banding or bariatric surgery.
- History of bowel obstruction, gallstones, gastroparesis, pancreas and liver/gallbaldder disorders.
- Any form of active substance abuse or dependence (including drug or alcohol abuse).
- 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
- 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.
- Unwillingness to adhere to study protocol
- Intent to increase or decrease body weight during the study period
- No Social Security number (for payment and IRS forms).
- Individuals who directly report to any member of the research team.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
Official title: Elucidating the Effect of Dietary Stearic Acid on the Regional Heterogeneity of the Gut Microbiome and Metabolome: Focus on Bile Acid Metabolism
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.
Read the detailed description
Stearic acid (18:0) is unique among saturated fatty acids (SFAs) as it does not increase cardiovascular disease (CVD) risk. Prior work by the study investigators suggests that gut microbiome-mediated alterations in secondary bile acid (BA) metabolism as a potential mechanism for the cholesterol-lowering effects of 18:0. However, to test this hypothesis the investigators were limited to traditional fecal sampling methods, which primarily reflect colonic microbes and do not capture regional heterogeneity in microbial communities or BA transformations which occur mainly in the small intestine. Using a novel ingestible device (mini-pill) which provides real-time sampling of the gastrointestinal environment, this study aims to comprehensively investigate the impact of dietary 18:0 on gut microbial BA transformations in modulating cardiometabolic risk. The study design includes a controlled 38-day dietary intervention trial in post-menopausal females using whole-foods enriched in commercially available sources of 18:0. The objectives are to determine the effect of dietary 18:0 on (i) microbiome composition and BA related functional pathways along the GI tract relative to stool; (ii) BA profiles along the GI tract, in stool and plasma; and (iii) FXR activation (reflected by FGF19 levels) and endogenous cholesterol synthesis in mediating the association between BA metabolizing microbes and BA profiles on CVD risk factors. Fecal whole-genome shotgun sequencing, targeted BA profiling, and bioinformatics will be used to address these objectives. Results will contribute to optimizing dietary/nutrient-labeling guidance to reduce CVD risk by expanding the evidence-base for classifying 18:0 and may offer novel strategies for preventing heart disease by targeting specific gut microbes or BA pathways.
- Conditions
- CVD Risk
- Being tested
- High Palmitic Acid Diet, High Stearic Acid Diet
- Keywords
- stearic acid, bile acid metabolism, post-menopausal women, dietary intervention, saturated fatty acids, gut microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Palmitic Acid DietOther
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).
High Stearic Acid DietOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: High Palmitic Acid Diet; Other: High Stearic Acid Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Abundance of Gut Microbial Taxa (%)
Gut microbial composition in gastrointestinal luminal and stool samples will be assessed using whole-genome shotgun metagenomic sequencing and reported as relative abundance (%). Alpha and beta diversity will also be evaluated as part of the microbiome analyses.
Measured: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Relative Abundance of Gut Microbial Functional Pathways (%)
Gut microbial functional pathways in gastrointestinal luminal and stool samples will be assessed from whole-genome shotgun metagenomic sequencing data using bioinformatic pathway analysis and reported as relative abundance (%). Analyses will include pathways related to bile acid metabolism as well as other microbial metabolic pathways.
Measured: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Concentrations of Bile Acids in Gastrointestinal Luminal Samples (nmol/mL)
Primary and secondary bile acids, including conjugated and unconjugated bile acids, will be quantified in gastrointestinal luminal samples using targeted mass spectrometry and reported as nmol/mL.
Measured: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Concentrations of Bile Acids in Plasma (nmol/mL)
Primary and secondary bile acids, including conjugated and unconjugated bile acids, will be quantified in fasting and postprandial plasma using targeted mass spectrometry and reported as nmol/mL.
Measured: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Concentrations of Bile Acids in Stool (nmol/mg dry weight)
Primary and secondary bile acids, including conjugated and unconjugated bile acids, will be quantified in stool using targeted mass spectrometry, normalized to fecal dry weight, and reported as nmol/mg dry weight.
Measured: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Secondary outcomes (3)
Plasma Metabolite Concentrations (µmol/L)
Plasma metabolites will be measured using targeted metabolomic profiling and reported as concentrations in µmol/L.
Measured: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Fecal Metabolite Concentrations (nmol/mg dry weight)
Fecal metabolites will be measured using targeted metabolomic profiling, normalized to fecal dry weight, and reported as nmol/mg dry weight.
Measured: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Serum Cholesterol metabolism markers
Cholesterol synthesis markers (squalene, desmosterol, lathosterol) and cholesterol absorption markers (phytosterols) will be measured using gas-liquid chromatography, normalized to total cholesterol, and reported as 10² mmol/mol total cholesterol.
Measured: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CVD RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post study design. The entire study period will be approximately 38 days, starting with a 10-day controlled run-in phase (high palmitic acid diet) to stabilize baseline variables, and a 28-day controlled feeding phase (high stearic acid diet).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirupa Matthan, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766915
- Sponsor's protocol ID
- 7098
- Other IDs
- GRANT14224177
- Acronym
- SAMPill
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications arising from this study will be shared. This includes demographic characteristics, baseline measures, intervention exposure data, outcome measures, and other variables necessary to reproduce the primary and secondary analyses reported in study publications. All direct identifiers will be removed prior to data sharing.
Publications
Rodriguez-Morato J, Galluccio J, Dolnikowski GG, Lichtenstein AH, Matthan NR. Comparison of the Postprandial Metabolic Fate of U-13C Stearic Acid and U-13C Oleic Acid in Postmenopausal Women. Arterioscler Thromb Vasc Biol. 2020 Dec;40(12):2953-2964. doi: 10.1161/ATVBAHA.120.315260. Epub 2020 Oct 1.
PubMed 32998517Meng H, Matthan NR, Wu D, Li L, Rodriguez-Morato J, Cohen R, Galluccio JM, Dolnikowski GG, Lichtenstein AH. Comparison of diets enriched in stearic, oleic, and palmitic acids on inflammation, immune response, cardiometabolic risk factors, and fecal bile acid concentrations in mildly hypercholesterolemic postmenopausal women-randomized crossover trial. Am J Clin Nutr. 2019 Aug 1;110(2):305-315. doi: 10.1093/ajcn/nqz095.
PubMed 31179489Kris-Etherton PM, Griel AE, Psota TL, Gebauer SK, Zhang J, Etherton TD. Dietary stearic acid and risk of cardiovascular disease: intake, sources, digestion, and absorption. Lipids. 2005 Dec;40(12):1193-200. doi: 10.1007/s11745-005-1485-y.
PubMed 16477802
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Effect of Dietary Stearic Acid on the Regional Heterogeneity of the Gut Microbiome and Metabolome: Focus on Bile Acid Metabolism
- ClinicalTrials.gov ID
- NCT07766915
- Acronym / sponsor ID
- SAMPill / 7098
- Conditions
- CVD Risk
- Keywords
- stearic acid, bile acid metabolism, post-menopausal women, dietary intervention, saturated fatty acids, gut microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stearic acid (18:0) is unique among saturated fatty acids (SFAs) as it does not increase cardiovascular disease (CVD) risk. Prior work by the study investigators suggests that gut microbiome-mediated alterations in secondary bile acid (BA) metabolism as a potential mechanism for the cholesterol-lowering effects of 18:0. However, to test this hypothesis the investigators were limited to traditional fecal sampling methods, which primarily reflect colonic microbes and do not capture regional heterogeneity in microbial communities or BA transformations which occur mainly in the small intestine. Using a novel ingestible device (mini-pill) which provides real-time sampling of the gastrointestinal environment, this study aims to comprehensively investigate the impact of dietary 18:0 on gut microbial BA transformations in modulating cardiometabolic risk. The study design includes a controlled 38-day dietary intervention trial in post-menopausal females using whole-foods enriched in commercially available sources of 18:0. The objectives are to determine the effect of dietary 18:0 on (i) microbiome composition and BA related functional pathways along the GI tract relative to stool; (ii) BA profiles along the GI tract, in stool and plasma; and (iii) FXR activation (reflected by FGF19 levels) and endogenous cholesterol synthesis in mediating the association between BA metabolizing microbes and BA profiles on CVD risk factors. Fecal whole-genome shotgun sequencing, targeted BA profiling, and bioinformatics will be used to address these objectives. Results will contribute to optimizing dietary/nutrient-labeling guidance to reduce CVD risk by expanding the evidence-base for classifying 18:0 and may offer novel strategies for preventing heart disease by targeting specific gut microbes or BA pathways.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post study design. The entire study period will be approximately 38 days, starting with a 10-day controlled run-in phase (high palmitic acid diet) to stabilize baseline variables, and a 28-day controlled feeding phase (high stearic acid diet).
| Arm | Type | Receives |
|---|---|---|
| Palmitic Acid Run-In Followed by Stearic Acid Diet | Experimental | Other: High Palmitic Acid Diet, Other: High Stearic Acid DietA 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Normotensive with or without medication
Key exclusion criteria (20 listed)
- 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
- Current smokers or former smokers who quit < 6 months ago, and use of nicotine replacement products within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Palmitic Acid DietThe 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). | Other | Palmitic Acid Run-In Followed by Stearic Acid Diet |
| High Stearic Acid DietThe 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). | Other | Palmitic Acid Run-In Followed by Stearic Acid Diet |
Primary outcome
Relative Abundance of Gut Microbial Taxa (%)
Time frame: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Gut microbial composition in gastrointestinal luminal and stool samples will be assessed using whole-genome shotgun metagenomic sequencing and reported as relative abundance (%). Alpha and beta diversity will also be evaluated as part of the microbiome analyses.
Relative Abundance of Gut Microbial Functional Pathways (%)
Time frame: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Gut microbial functional pathways in gastrointestinal luminal and stool samples will be assessed from whole-genome shotgun metagenomic sequencing data using bioinformatic pathway analysis and reported as relative abundance (%). Analyses will include pathways related to bile acid metabolism as well as other microbial metabolic pathways.
Concentrations of Bile Acids in Gastrointestinal Luminal Samples (nmol/mL)
Time frame: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Primary and secondary bile acids, including conjugated and unconjugated bile acids, will be quantified in gastrointestinal luminal samples using targeted mass spectrometry and reported as nmol/mL.
Concentrations of Bile Acids in Plasma (nmol/mL)
Time frame: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Primary and secondary bile acids, including conjugated and unconjugated bile acids, will be quantified in fasting and postprandial plasma using targeted mass spectrometry and reported as nmol/mL.
Concentrations of Bile Acids in Stool (nmol/mg dry weight)
Time frame: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Primary and secondary bile acids, including conjugated and unconjugated bile acids, will be quantified in stool using targeted mass spectrometry, normalized to fecal dry weight, and reported as nmol/mg dry weight.
3 secondary outcomes
Plasma Metabolite Concentrations (µmol/L)
Time frame: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Fecal Metabolite Concentrations (nmol/mg dry weight)
Time frame: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Serum Cholesterol metabolism markers
Time frame: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 32998517Rodriguez-Morato J, Galluccio J, Dolnikowski GG, Lichtenstein AH, Matthan NR. Comparison of the Postprandial Metabolic Fate of U-13C Stearic Acid and U-13C Oleic Acid in Postmenopausal Women. Arterioscler Thromb Vasc Biol. 2020 Dec;40(12):2953-2964. doi: 10.1161/ATVBAHA.120.315260. Epub 2020 Oct 1.
- Background: PubMed 31179489Meng H, Matthan NR, Wu D, Li L, Rodriguez-Morato J, Cohen R, Galluccio JM, Dolnikowski GG, Lichtenstein AH. Comparison of diets enriched in stearic, oleic, and palmitic acids on inflammation, immune response, cardiometabolic risk factors, and fecal bile acid concentrations in mildly hypercholesterolemic postmenopausal women-randomized crossover trial. Am J Clin Nutr. 2019 Aug 1;110(2):305-315. doi: 10.1093/ajcn/nqz095.
- Background: PubMed 16477802Kris-Etherton PM, Griel AE, Psota TL, Gebauer SK, Zhang J, Etherton TD. Dietary stearic acid and risk of cardiovascular disease: intake, sources, digestion, and absorption. Lipids. 2005 Dec;40(12):1193-200. doi: 10.1007/s11745-005-1485-y.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications arising from this study will be shared. This includes demographic characteristics, baseline measures, intervention exposure data, outcome measures, and other variables necessary to reproduce the primary and secondary analyses reported in study publications. All direct identifiers will be removed prior to data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Palmitic Acid Diet and High Stearic Acid Diet in people with CVD Risk, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nirupa R Matthan, PhD (6175563114, nirupa.matthan@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Abundance of Gut Microbial Taxa (%) (time frame: End of the 10-day palmitic acid run-in period and end of the 28-day stearic acid intervention period.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07766915, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.