Clinical trial NCT06777498: The Precision Nutrition New York Study
Official title: Optimizing Dietary Fiber Eating Patterns to Prevent Obesity and Resulting Metabolic Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Body Composition Changes
Body Weight Changes
Keywords: dietary fiber
gut microbiome
gut microbiota
short-chain fatty acids
SCFAs
whole grains
fruits
vegetables
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to one of two parallel arms in the intervention study. During each of the arms (pre and end time points), investigators will collect fecal samples and weigh the participants and measure body composition.
Primary purpose: SUPPORTIVE_CARE

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.

Primary outcomes:
measure: Body weight changes
timeFrame: 3-4 weeks
measure: Body fat percentage changes
timeFrame: 3-4 weeks
Secondary outcomes:
measure: Gut microbiome measured by 16S rRNA gene sequencing
timeFrame: 3-4 weeks
measure: Fecal short-chain fatty acid concentrations (SCFAs)
timeFrame: 3-4 weeks
Other outcomes:
Locations:
Study officials:
References: