Body Composition ChangesPNNYNCT06777498
The Precision Nutrition New York Study
A study testing Whole Grain Intervention then fruits and vegetables and Fruit and Vegetable Intervention and then whole grains in people with Body Composition Changes and Body Weight Changes, run by Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition Changes, Body Weight Changes
- What is being tested?
- Whole Grain Intervention then fruits and vegetables and Fruit and Vegetable Intervention and then whole grains
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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)
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colette Strathman contact
United States1 site, 1 recruiting
- Recruiting
Cornell University
Ithaca, New York, 14850
Angela Poole, PhD, 607-255-8796, pnnystudy@cornell.edu
Angela Poole, PhD
About this study
Official title: Optimizing Dietary Fiber Eating Patterns to Prevent Obesity and Resulting Metabolic Disorders
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
- Being tested
- Whole Grain Intervention then fruits and vegetables, Fruit and Vegetable Intervention and then whole grains
- Keywords
- dietary fiber, gut microbiome, gut microbiota, short-chain fatty acids, SCFAs, whole grains, fruits, vegetables
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Grain Intervention then fruits and vegetablesOther
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 grainsOther
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 group | Role | What they receive |
|---|---|---|
| Experimental: Group A: Whole grains then fruits and vegetables | Experimental | Whole grain intervention then fruits and vegetables Receives: 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 Receives: Other: Fruit and Vegetable Intervention and then whole grains |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3-4 weeks
Secondary outcomes (2)
Gut microbiome measured by 16S rRNA gene sequencing
For each intervention (whole grains \& fruits and vegetables), investigators will calculate changes in relative abundance (proportion) of each gut bacterium from Pre-intervention to Post-intervention.
Measured: 3-4 weeks
Fecal short-chain fatty acid concentrations (SCFAs)
For each intervention (whole grains \& fruits and vegetables), investigators will measure change in SCFA concentrations = Post-intervention minus Pre-intervention. We will report the SCFAs acetate, butyrate, and propionate.
Measured: 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start13 Jan 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Composition ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777498
- Sponsor's protocol ID
- IRB0147806
- Other IDs
- 7005865
- Acronym
- PNNY
- Status last verified
- Jul 2025
- First submitted
- 6 Jan 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will NEVER share de-identified data about the participants. Our previous publications show aggregated data results. This study is identical to our previous in design, sample types, and data being collected. We shared the de-identified 16S rRNA sequence data of the participants in a public database as requested by the journals. When requested by a journal, we have shared eligibility criteria. Some journals may require us to share our statistical code.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Dietary Fiber Eating Patterns to Prevent Obesity and Resulting Metabolic Disorders
- ClinicalTrials.gov ID
- NCT06777498
- Acronym / sponsor ID
- PNNY / IRB0147806
- Conditions
- Body Composition Changes, Body Weight Changes
- Keywords
- dietary fiber, gut microbiome, gut microbiota, short-chain fatty acids, SCFAs, whole grains, fruits, vegetables
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group A: Whole grains then fruits and vegetables | Experimental | Other: Whole Grain Intervention then fruits and vegetablesWhole grain intervention then fruits and vegetables |
| Experimental: Group B: Fruits and vegetables then whole grains | Experimental | Other: Fruit and Vegetable Intervention and then whole grainsFruits and vegetables intervention then whole grains |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Grain Intervention then fruits and vegetablesTREATMENT 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 | Experimental: Group A: Whole grains then fruits and vegetables |
| Fruit and Vegetable Intervention and then whole grainsTREATMENT 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. | Other | Experimental: Group B: Fruits and vegetables then whole grains |
Primary outcome
Body weight changes
Time frame: 3-4 weeks
For each intervention (whole grains \& fruits and vegetables), investigators will measure change in body weight in kg = Post-intervention minus Pre-intervention
Body fat percentage changes
Time frame: 3-4 weeks
For each intervention (whole grains \& fruits and vegetables), investigators will measure change in fat percentage = Post-intervention minus Pre-intervention
2 secondary outcomes
Gut microbiome measured by 16S rRNA gene sequencing
Time frame: 3-4 weeks
Fecal short-chain fatty acid concentrations (SCFAs)
Time frame: 3-4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Undecided. We will NEVER share de-identified data about the participants. Our previous publications show aggregated data results. This study is identical to our previous in design, sample types, and data being collected. We shared the de-identified 16S rRNA sequence data of the participants in a public database as requested by the journals. When requested by a journal, we have shared eligibility criteria. Some journals may require us to share our statistical code.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colette Strathman contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Grain Intervention then fruits and vegetables and Fruit and Vegetable Intervention and then whole grains in people with Body Composition Changes and Body Weight Changes, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Poole (607-255-8796, pnnystudy@cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight changes (time frame: 3-4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025; AzTrials last refreshed its copy on 28 Oct 2026.