Grape Powder for Psychological Distress

Overseen By Shreya Ghosh

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Antibiotics, Polyphenol-interfering

Disqualifiers: Celiac, Inflammatory bowel, Diabetes, Immunocompromised, others

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether freeze-dried table grape powder can reduce anxiety, depression, and stress in college students. It also investigates the potential benefits of this grape powder on gut health. Participants will take either the grape powder or a placebo daily for four weeks and record their intake. This study suits healthy college students not taking certain medications or with specific health conditions like diabetes or celiac disease. As an unphased trial, it offers a unique opportunity to explore natural methods for enhancing mental and gut health.

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

If you're taking medications that interfere with polyphenol, you cannot participate in the trial. The protocol doesn't specify other medication restrictions, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that freeze-dried table grape powder is safe?

Research has shown that freeze-dried table grape powder (FTGP) might be safe for people. Animal studies found that grape powder can reduce anxiety-like behaviors, suggesting it might help manage stress without causing harm. Grapes, rich in flavonoids—natural compounds found in many fruits—are generally well-tolerated.

While specific data on side effects in humans from these studies is lacking, FTGP comes from grapes, a common food, suggesting it is likely safe to consume. Those with health concerns or conditions should consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for psychological distress, which often involve pharmaceuticals like antidepressants or therapy, freeze-dried table grape powder (FTGP) offers a natural alternative. Researchers are excited about FTGP because it harnesses the potential benefits of grapes, which are rich in antioxidants and polyphenols, to potentially improve mental well-being. This approach is distinct because it leverages the natural ingredients found in grapes, providing a dietary supplement that could be easier to incorporate into daily life with fewer side effects than conventional medications.

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

Research shows that grapes can benefit mental health. Studies have found that grape powder reduces anxiety and improves memory in animals. Some research also suggests that grapes boost brain function, enhancing cognitive performance. Eating grape powder might protect against stress, making it a potential "stress snack." This trial will evaluate the effects of freeze-dried table grape powder on psychological distress. Participants will receive either a daily supplement containing freeze-dried table grape powder or a placebo for 4 weeks. These findings suggest that freeze-dried table grape powder could reduce anxiety and improve mental well-being. ^{2 6 7 8 9}

Who Is on the Research Team?

Guojun Wu

Principal Investigator

Rutgers, The State University of New Jersey

Are You a Good Fit for This Trial?

This trial is for college students who are experiencing psychological distress. Participants will be asked to drink a daily supplement and keep a log, complete surveys, and provide stool samples over the course of 4 weeks with three in-person visits.

Inclusion Criteria

Able to give written informed consent

BMI 18.5-24.9 kg/m2

Healthy (self-reported)

Exclusion Criteria

Are pregnant or breastfeeding

Have a history of or current alcohol, drug, or medication abuse (self-reported)

I have undergone bariatric surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants drink a daily supplement containing FTGP or a placebo for 4 weeks, record consumption in a compliance log, complete surveys, and provide stool samples.

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in psychological distress and gut microbiota after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Freeze-Dried Table Grape Powder

Trial Overview The study is testing whether freeze-dried table grape powder (FTGP) can reduce anxiety, depression, and stress while improving gut microbiota compared to a placebo. The effects of FTGP on both mental health and gut health are being closely examined.

How Is the Trial Designed?

Group I: freeze-dried table grape powder (FTGP) Experimental Treatment 1 Intervention

Drink a daily supplement containing FTGP for 4 weeks

Group II: Placebo Placebo Group 1 Intervention

Drink a daily supplement containing a placebo for 4 weeks

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

California Table Grape Commission

Collaborator

Trials

8

Recruited

270+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8829676/

The effect of grape interventions on cognitive and mental ... The results across studies show that grapes can enhance some aspects of cognition, after both acute and chronic interventions.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0271531715001001

Grape powder treatment prevents anxiety-like behavior in a ... We have reported that grape powder (GP) treatment prevented pharmacologic and psychological stress-induced anxiety-like behavior and memory impairment in rats.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3652881/

Grape Powder Supplementation Prevents Oxidative Stress ... The present study demonstrates that consumption of freeze-dried grape powder has a protective effect on anxiety-like behavior, memory function, and high ...

4. researchgate.net researchgate.net/publication/351919597_The_effect_of_grape_interventions_on_cognitive_and_mental_performance_in_healthy_participants_and_those_with_mild_cognitive_impairment_a_systematic_review_of_randomized_controlled_trials

The effect of grape interventions on cognitive and mental ... The results across studies show that grapes can enhance some aspects of cognition, after both acute and chronic interventions.

5. ctv.veeva.com ctv.veeva.com/study/de-stressing-the-brain-can-eating-grapes-during-periods-of-mental-stress-protect-brain-and-vascular

De-stressing the Brain: Can Eating Grapes During Periods of Mental ... These data will establish whether grapes can be effective as a 'stress snack' to optimize cognitive and brain function in the context of psychological stress.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4329242/

Grape powder prevents cognitive, behavioral and biochemical ... First, SPS is an excellent rodent model of Post-Traumatic Stress Disorder (PTSD) as it mimics clinical symptoms of PTSD, including anxiety, depression and ...

7. grapesfromcalifornia.com grapesfromcalifornia.com/wp-content/uploads/2023/03/20230328-freeze-dried-table-grape-powder-overview-2023-24.pdf

Freeze-Dried Table Grape Powder Overview Grapes are high in flavonoids and are particularly good sources of flavans. For example, the major phenolic compound in grapes is catechin, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07079982

Effects of Freeze-dried Grape Powder on Immune Profiles ... Self-reported and/or physician-diagnosed history of diabetes mellitus, coronary heart disease, stroke, renal or liver disease, cancer, eating disorders, certain ...

9. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLViooSi3LzC8tVtJR8nMOMTAxNjMyNDdT0tG1hAEcTEMDPTMzSzNDYx1Dc0NLc0sjAzDQUcpLLjEwNTc0sDCxUIoFAI_rFoo-

Save Selected The goal of this trial is to investigate the effect of freeze-dried table grape powder (FTGP) on psychological distress and gut microbiota in college students.