Whole Grains and Fruits for Obesity

(PNNY Trial)

Overseen By Colette Strathman

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Cornell University

Must not be taking: Antibiotics

Disqualifiers: Electronic implants, Untreated thyroid, Immunosuppression, Gastrointestinal disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3-4 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 21-50 with a BMI of 25-30, who can measure their body size and composition, provide saliva samples, contact details, follow a high-fiber diet plan from the USDA MyPlate website, keep food records twice weekly, and give stool samples over an 11-week period. Stable weight in the last two months is required.

Inclusion Criteria

I can complete an online survey about my recent fiber intake.

I can track and report my food, drink, and supplement intake twice a week online.

* 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dietary interventions with either whole grains or fruits and vegetables to evaluate gut microbiota response

3-4 weeks

Follow-up

Participants are monitored for changes in body weight, body fat percentage, and gut microbiome composition after the dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fruit and Vegetable Intervention and then whole grains
• Whole Grain Intervention then fruits and vegetables

Trial Overview The study tests how different fiber sources—whole grains followed by fruits and vegetables or vice versa—affect gut microbes and health. It aims to find predictors for individual responses to these fibers to tailor personalized nutrition plans.

How Is the Trial Designed?

Group I: Experimental: Group B: Fruits and vegetables then whole grains Experimental Treatment 1 Intervention

Fruits and vegetables intervention then whole grains

Group II: Experimental: Group A: Whole grains then fruits and vegetables Experimental Treatment 1 Intervention

Whole grain intervention then fruits and vegetables

Who Is Running the Clinical Trial?

Cornell University

Lead Sponsor

Trials

179

Recruited

14,090,000+