The Precision Nutrition New York Study

Part of paid clinical trials in Ithaca, New York.

Sponsor
Cornell University
Study ID
NCT06777498
Status
Recruiting

Conditions

  • Body Composition Changes
  • Body Weight Changes

Eligibility Criteria

Sex
ALL
Age
21 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Whole Grain Intervention then fruits and vegetables — OTHER
    TREATMENT 1: Participants will eat whole grains that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when they eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual. TREATMENT 2: Participants will eat fruits and vegetables that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when participants eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual.
  • Fruit and Vegetable Intervention and then whole grains — OTHER
    TREATMENT 1: Participants will eat fruits and vegetables that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when participants eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual. TREATMENT 2: Participants will eat whole grains that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when they eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual.

Study Details

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.

Key Dates

Start date
Jan 13, 2025
Status verified
Jul 2025
Primary completion
Oct 1, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental: Group A: Whole grains then fruits and vegetables
    Whole grain intervention then fruits and vegetables
  • Experimental: Experimental: Group B: Fruits and vegetables then whole grains
    Fruits and vegetables intervention then whole grains

Primary Outcome Measure

Body weight changes [ Time Frame: 3-4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cornell UniversityIthacaNew York14850
Angela Poole, PhD
607-255-8796
Angela Poole, PhD (PRINCIPAL_INVESTIGATOR)

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