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?

This trial aims to understand how different sources of dietary fiber from whole grains and fruits and vegetables affect gut health and assist with obesity. Participants will first follow either a fruit and vegetable diet or a whole grain diet, then switch to the other. Researchers seek to observe how these foods alter gut microbes and their benefits. Individuals with a stable weight recently and the ability to increase fiber intake as advised may be a good fit. As an unphased trial, this study offers participants the opportunity to contribute to valuable research on diet and gut health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a chronic condition requiring ongoing medication, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that eating more fruits and vegetables can help reduce obesity. Studies have found that increasing fruit intake can lower obesity rates. Additional research supports that consuming more fruits and vegetables effectively reduces obesity and being overweight.

Regarding whole grains, research suggests they might help lower body weight and reduce the risk of obesity. Some studies found that eating more whole grains links to a lower chance of obesity. However, other studies reported no significant effect on weight from eating whole grains alone.

Fruits, vegetables, and whole grains are part of a healthy diet and are generally easy for most people to digest. Unlike medicines, they usually don't cause side effects, making them safe options for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they emphasize the power of diet, specifically increasing whole grains, fruits, and vegetables, in tackling obesity. Unlike conventional weight management approaches that often rely on medication or calorie restriction, these treatments explore the natural benefits of nutrient-rich foods. Whole grains and fruits are packed with fiber, which can enhance satiety and improve metabolic health, potentially offering a more sustainable and holistic approach to weight loss. By shifting the focus to dietary interventions, these treatments aim to provide a natural and accessible alternative that could empower individuals to manage their weight effectively.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare two dietary interventions for obesity: one group will start with a fruit and vegetable intervention followed by whole grains, while the other group will begin with a whole grain intervention followed by fruits and vegetables. Studies have shown that increasing fruit and vegetable intake can help reduce obesity. One review of several studies found that efforts to increase fruit intake effectively lowered obesity rates. Similarly, eating more vegetables has been linked to slight weight loss over time. Research on whole grains shows mixed results. Some studies suggest whole grains might slightly lower body weight and improve heart health, while others found no significant impact on weight. However, incorporating whole grains into a balanced diet might reduce the risk of obesity. Overall, increasing consumption of fruits, vegetables, and whole grains can offer health benefits, though effects may vary from person to person. ^{1 2 3 4 5}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6266069/

The Relationship between Vegetable Intake and Weight ... Two showed that increasing vegetable consumption resulted in weight loss of 0.09–0.1 kg over four years (p < 0.001). Increased vegetable intake was also ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743523003717

The estimated effect of increasing fruit interventions on ... Conclusions. This meta-analysis provided evidence that interventions aimed at increasing fruit consumption were effective at reducing obesity prevalence.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009520

Impact of Produce Prescriptions on Diet, Food Security ... Produce prescriptions may improve cardiometabolic health by increasing fruit and vegetable (F&V) consumption and food insecurity.

4. who.int who.int/tools/elena/interventions/fruit-vegetables-ncds

Increasing fruit and vegetable consumption to reduce the ... WHO suggests consuming more than 400 grams of fruits and vegetables per day to improve overall health and reduce the risk of certain NCDs.

5. odphp.health.gov odphp.health.gov/healthypeople/tools-action/browse-evidence-based-resources/obesity-meal-or-fruit-and-vegetable-snack-interventions-increase-healthier-foods-and-beverages-provided-schools

Obesity: Meal or Fruit and Vegetable Snack Interventions to ... In addition, CPSTF found that the interventions reduce obesity and overweight and are cost-effective.