The Precision Nutrition New York Study
Launched by CORNELL UNIVERSITY · Jan 14, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The Precision Nutrition New York Study is looking at how different sources of dietary fiber, like whole grains and fruits and vegetables, affect our gut health. Researchers want to understand why some people benefit more from fiber than others and what factors influence those differences. By finding out which aspects of a person's health predict how their gut responds to fiber, the study aims to develop personalized nutrition plans that can help everyone get the most health benefits from their diet.
To be eligible for this study, participants need to be between 21 and 50 years old and have a body mass index (BMI) between 25 and 30, which indicates being overweight. They should also have a stable weight for the past two months and be willing to provide saliva and stool samples, along with keeping a record of their food intake for two specific days each week. Participants will be asked to increase their fiber intake according to guidelines and will be monitored for about 11 weeks. If you have certain health conditions or have recently changed your diet significantly, you may not qualify. This study provides a unique opportunity to contribute to research that could lead to better dietary recommendations tailored to individual needs.
Gender
ALL
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.
About Cornell University
Cornell University is a prestigious Ivy League institution renowned for its commitment to academic excellence and innovative research. As a clinical trial sponsor, Cornell leverages its interdisciplinary expertise and state-of-the-art facilities to advance medical knowledge and improve patient outcomes. The university fosters collaboration among leading researchers, clinicians, and students, aiming to translate scientific discoveries into effective therapies. Cornell's rigorous adherence to ethical standards and regulatory compliance ensures the integrity and safety of its clinical trials, contributing to the advancement of healthcare and the well-being of communities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported