| NCT ID | NCT06777498 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cornell University |
| Condition | Body Composition Changes |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-01-13 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dietary fiber has been shown to have beneficial effects on human health through its impact on microbes present in the gut. However, these effects can vary between individuals, and everyone may not reap the same health benefits by eating the same sources of fiber. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes change in response to different sources of fiber would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber. The objective of this study is to evaluate candidate predictors of gut microbiota response to fiber sources from either whole grains or fruits and vegetables.
Eligibility Criteria
Inclusion Criteria: * Age is between 21-50 years * BMI is between 25-30. You can check your BMI here: https://www.cdc.gov/bmi/adult-calculator/index.html * Must be able to have height, weight, waist, and hip circumference, and body composition measured during the study * Must be able to provide saliva samples. * Must be able to provide a phone number and email address at which the study investigators can contact for study-related matters. * Must be able to increase dietary fiber intake to the recommended level following the instructions on the USDA MyPlate website: https://www.myplate.gov/myplate-plan * Must be able to provide food records of everything consumed (food, beverage, and supplements) on one weekday and one weekend day (example Tuesday, Saturday) every week during the study. This will be done using an online survey. * Must be able to provide 10 stool samples over 11 weeks of the study duration. 18) Must have stable weight (within ±3% of usual body weight) for the last two months. * Must be able to to take an online survey to assess recent dietary fiber intake to determine eligibility. Exclusion Criteria: * Electronic medical implant, for example, a pacemaker. * An existing, UNTREATED, thyroid condition. * Use of systemic antibiotics (intravenous injection, intramuscular, or oral) within the last 4 months. * An acute disease at the time of enrollment (Acute disease is defined as the presence of a moderate or severe illness with or without fever). * A chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality. * Any suspected state of immunosuppression or immunodeficiency including HIV. * A history of active UNTREATED gastrointestinal disorders or diseases including 1. Inflammatory bowel disease (IBD) 2. Ulcerative colitis (mild-moderate-severe) 3. Crohn's or celiac disease 4. Indeterminate colitis 5. Irritable bowel syndrome (IBS) (moderate-severe) 6. Persistent, infectious gastroenteritis, colitis or gastritis 7. Persistent or chronic diarrhea of unknown etiology 8. Clostridium difficile infection (recurrent) 9. Chronic constipation * Previously had bariatric surgery. * An unstable dietary history as defined by major changes in diet during the previous month. For example, elimination or significantly increased intake of a major food group in the diet. * Recent history of chronic alcohol consumption defined as more than 5 drinks (or servings) of alcohol per day. * Female participants: pregnant/lactating.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06777498 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 50 Years, studying Body Composition Changes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06777498 currently recruiting?
Yes, NCT06777498 is actively recruiting participants. Contact the research team at pnnystudy@cornell.edu for enrollment information.
Where is the NCT06777498 trial being conducted?
This trial is being conducted at Ithaca, United States.
Who is sponsoring the NCT06777498 clinical trial?
NCT06777498 is sponsored by Cornell University. The trial plans to enroll 15 participants.