The Precision Nutrition New York Study

NCT06777498 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-07-11

No results posted yet for this study

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.

Conditions

  • Body Composition Changes
  • Body Weight Changes

Interventions

OTHER

Whole Grain Intervention then fruits and vegetables

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.

OTHER

Fruit and Vegetable Intervention and then whole grains

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2025-10-01
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06777498 on ClinicalTrials.gov