Actively Recruiting

Phase Not Applicable
Age: 21Years - 50Years
All Genders
Healthy Volunteers
NCT06777498

The Precision Nutrition New York Study

Led by Cornell University · Updated on 2025-07-11

15

Participants Needed

1

Research Sites

50 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

The Precision Nutrition New York Study

Who Can Participate

Age: 21Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age is between 21-50 years
  • BMI is between 25-30
  • Able to have height, weight, waist, and hip circumference, and body composition measured during the study
  • Able to provide saliva samples
  • Able to provide a phone number and email address for study contact
  • Able to increase dietary fiber intake to recommended levels following USDA MyPlate instructions
  • Able to provide food records of all consumed items on one weekday and one weekend day weekly using an online survey
  • Able to provide 10 stool samples over 11 weeks
  • Stable weight within plus or minus 3% of usual body weight for the last two months
  • Able to take an online survey to assess recent dietary fiber intake for eligibility
Not Eligible

You will not qualify if you...

  • Has an electronic medical implant such as a pacemaker
  • Has an existing, untreated thyroid condition
  • Used systemic antibiotics in the last 4 months
  • Has an acute disease at enrollment, defined as moderate or severe illness with or without fever
  • Has a chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality requiring ongoing management
  • Suspected immunosuppression or immunodeficiency including HIV
  • Has a history of active untreated gastrointestinal disorders including inflammatory bowel disease, ulcerative colitis, Crohn's or celiac disease, indeterminate colitis, moderate to severe irritable bowel syndrome, persistent infectious gastroenteritis, chronic diarrhea of unknown cause, recurrent Clostridium difficile infection, or chronic constipation
  • Previously had bariatric surgery
  • Has had major diet changes in the last month, such as eliminating or greatly increasing a major food group
  • Has a recent history of chronic alcohol use exceeding 5 drinks per day
  • Female participants who are pregnant or lactating

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cornell University

Ithaca, New York, United States, 14850

Actively Recruiting

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Research Team

A

Angela Poole

CONTACT

C

Colette Strathman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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