Precision Nutrition New York: Whole grains versus fruits & vegetables for your gut and body

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with BMI 25–30 will follow two different fiber-focused diets—one emphasizing whole grains and one emphasizing fruits and vegetables—in alternating order. Participants provide repeated stool and saliva samples, body composition and anthropometric measurements, and weekly food records over an 11-week period with a total of 10 stool collections. The study looks for predictors that explain why some people’s gut microbiota and microbial metabolites (like SCFAs) respond differently to different fiber sources. Findings will be used to inform more personalized dietary fiber recommendations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cornell University
  Ithaca, New York, United States Recruiting

Study contacts

• Study coordinator: Angela Poole
• Email: pnnystudy@cornell.edu
• Phone: 607-255-8796

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.