Grape Powder for Obesity

CW
JD
Overseen ByJaapna Dhillon PhD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how freeze-dried grape powder might aid obesity management by influencing the immune system and digestion. Participants will begin with either grape powder or a placebo (a powder with no active ingredients) for four weeks, then switch after a break. It is ideal for adults with obesity who have a stable weight and can maintain a consistent diet and lifestyle. As an unphased trial, this study allows participants to contribute to groundbreaking research on natural interventions for obesity.

Do I need to stop taking my current medications for the trial?

The trial requires that you not be on certain medications, especially those affecting immune function, metabolism, or appetite. If you're on medications for heart disease or related conditions, you may not be eligible. It's best to discuss your specific medications with the trial team.

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

Research has shown that freeze-dried grape powder is generally well-tolerated. Studies have found that grapes are rich in polyphenols and fibers, which benefit health. These nutrients are naturally present in grapes, making them safe for daily consumption.

No specific evidence of harmful effects from freeze-dried grape powder has emerged in studies. Overall, it appears safe for consumption based on its nutrient content. However, consulting a doctor before joining any trial is important to ensure it is appropriate.12345

Why are researchers excited about this trial?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications, or surgery, this investigational treatment uses freeze-dried grape powder. Researchers are intrigued because grape powder is a natural, plant-based option that could offer a gentler alternative with fewer side effects than conventional drugs. It contains polyphenols, which may help regulate metabolism and reduce inflammation, potentially addressing obesity in a novel way. Additionally, the crossover design of the treatment—switching between grape powder and a placebo—might provide clearer insights into its effectiveness.

What evidence suggests that freeze-dried grape powder might be an effective treatment for obesity?

Research has shown that freeze-dried grape powder may help with obesity. Previous studies have found that it can significantly lower body weight and body mass index (BMI), a measure of body fat using height and weight. Another study discovered that grape powder reduced fasting plasma triglycerides, fats in the blood that can be harmful if too high. In this trial, participants will receive either freeze-dried grape powder or a placebo in different sequences. These findings suggest that grape powder might be useful for managing weight and improving blood fat levels in people with obesity.14678

Are You a Good Fit for This Trial?

Adults aged 30-45 with obesity (BMI of 30-45 kg/m2) who are non-smokers, have had a stable weight and consistent diet/activity for the last 3 months, and do not follow an extremely healthy diet. Excluded are those with HIV, recent immune-affecting meds use, pregnancy, diabetes, gastrointestinal issues or surgery, uncontrolled hypertension, drug abuse history or certain medication uses.

Inclusion Criteria

I am between 30 and 45 years old.
Willingness to consume study foods
Consistent diet and activity patterns for 4 weeks
See 4 more

Exclusion Criteria

I am HIV positive.
I have recently used medications that affect my immune system.
Pregnant or lactating individuals
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants consume 48g/day of whole freeze-dried grape powder for 4 weeks

4 weeks
Weekly visits for assessments

Washout

Participants undergo a 4-week washout period between treatments

4 weeks

Treatment Phase 2

Participants consume isocaloric placebo powder for 4 weeks

4 weeks
Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Freeze-dried grape powder
Trial Overview The trial is testing if consuming freeze-dried grape powder can benefit the immune-gut axis in obese adults compared to a placebo. Participants will be randomly assigned to receive either the grape powder or a placebo and monitored for changes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Sequence 2: Placebo then GrapeExperimental Treatment2 Interventions
Group II: Sequence 1: Grape then PlaceboExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials
387
Recruited
629,000+

California Table Grape Commission

Collaborator

Trials
8
Recruited
270+

Citations

Effects of Grape Consumption on the Immune-Gut Axis in ...This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity. Detailed Description. The ...
Effects of A Standardized, Freeze-Dried Grape Powder in ...conducted a study to evaluate the effectiveness of GRAPE on obese individuals. Twenty-four obese adults (BMI 30-45kg/m2), aged 20-60 years ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/30129815/
Effects of Freeze-Dried Grape Powder on High-Density ...Grape powder did not impact HDL function, but it did reduce fasting plasma triglycerides in adults with metabolic syndrome.
Effects of grape consumption on biomarkers ...This study investigated effects of grape consumption on biomarkers of cardiovascular health in obese participants in both postprandial and ...
Effects of A Standardized, Freeze-Dried Grape Powder in ...Result: The outcomes have revealed grape products intake to significantly decrease body weight (p = 0.001) and body mass index (p = 0.004) in obese ...
Effect of Standardized Grape Powder Consumption on the ...Grapes provide a rich source of polyphenols and fibers. This study aimed to evaluate the effect of the daily consumption of 46 g of whole ...
Effects of Freeze-dried Grape Powder on Immune Profiles ...A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...
Grape powder attenuates the negative effects of GLP-1 ...Grape powder significantly reduced (p < 0.01) blood glucose levels following oral glucose gavage after GLP-1 receptor antagonism by exendin-3 (9–39)
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