The Precision Nutrition New York Study

NCT06777498 | Recruiting

• 2 other identifiers: IRB01478067005865
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Composition Changes; Body Weight Changes

Keywords

dietary fiber; gut microbiome; gut microbiota; short-chain fatty acids; SCFAs; whole grains; fruits; vegetables

Outcome Measures

Primary Outcomes (2)

• Body weight changes

  For each intervention (whole grains \& fruits and vegetables), investigators will measure change in body weight in kg = Post-intervention minus Pre-intervention

  3-4 weeks

• Body fat percentage changes

  For each intervention (whole grains \& fruits and vegetables), investigators will measure change in fat percentage = Post-intervention minus Pre-intervention

  3-4 weeks

Secondary Outcomes (2)

• Gut microbiome measured by 16S rRNA gene sequencing

  3-4 weeks

• Fecal short-chain fatty acid concentrations (SCFAs)

  3-4 weeks

Study Arms (2)

Experimental: Group A: Whole grains then fruits and vegetables

EXPERIMENTAL

Whole grain intervention then fruits and vegetables

Other: Whole Grain Intervention then fruits and vegetables

Experimental: Group B: Fruits and vegetables then whole grains

EXPERIMENTAL

Fruits and vegetables intervention then whole grains

Other: Fruit and Vegetable Intervention and then whole grains

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.

Experimental: Group A: Whole grains then fruits and vegetables

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.

Experimental: Group B: Fruits and vegetables then whole grains

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Inflammatory bowel disease (IBD)
• Ulcerative colitis (mild-moderate-severe)
• Crohn's or celiac disease
• Indeterminate colitis
• Irritable bowel syndrome (IBS) (moderate-severe)
• Persistent, infectious gastroenteritis, colitis or gastritis
• Persistent or chronic diarrhea of unknown etiology
• Clostridium difficile infection (recurrent)

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Cornell University

Ithaca, New York, 14850, United States

RECRUITING

MeSH Terms

Conditions

Body Weight Changes

Interventions

Vegetables; Fruit

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Angela Poole

CONTACT

607-255-8796; pnnystudy@cornell.edu

Colette Strathman

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 16, 2025
• Study Start: January 13, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

US (1)