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Prebiotic

Grapes for Gut and Heart Health (CALGRAM Trial)

N/A

Waitlist Available

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Post-menopausal women (cessation of menstruation for minimum two years)

Without treatment for diabetes or metabolic syndrome

Must not have

Any serious medical condition including but not limited to coronary artery disease, uncontrolled hypertension, stroke, congestive heart failure, insulin-dependent diabetes, liver disease, active cancer and anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (visit 1), week 4 (visit 2), week 12 (visit 4)

Summary

This trial aims to see how eating table grapes affects the gut health, inflammation, and blood vessel function in healthy overweight men and women aged 45-70. They want to know if eating grapes can

Who is the study for?

This trial is for healthy overweight men and women aged 45-70 who want to explore the health benefits of grape powder on gut and heart health. Participants should not have major health issues but may have concerns like high blood pressure or arterial stiffness. They must be willing to consume a test product daily and follow their usual diet with some restrictions.

What is being tested?

Researchers are testing if consuming freeze-dried grape powder can improve gut microbiome, intestinal permeability, inflammation levels, and vascular function compared to a placebo. The study involves taking the powder dissolved in water twice daily for four weeks while maintaining a normal diet with limited polyphenol-rich foods.

What are the potential side effects?

Since this trial involves food-based interventions (grape powder), side effects might be minimal but could include digestive discomfort or allergic reactions in rare cases. Any changes in bowel habits or unexpected symptoms will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had a menstrual period for at least two years.

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I am not receiving treatment for diabetes or metabolic syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious medical conditions like heart disease, uncontrolled high blood pressure, diabetes, liver disease, or active cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (visit 1), week 4 (visit 2), week 12 (visit 4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (visit 1), week 4 (visit 2), week 12 (visit 4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (visit 1), week 4 (visit 2), week 12 (visit 4) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Arterial stiffness Change from Baseline

Blood pressure Change from Baseline

Gut microbiome composition Change from Baseline

+3 more

Secondary study objectives

Global gene expression Change from Baseline

Gut permeability marker Change from Baseline

Metabolomics and Lipidomics Change from Baseline

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, Then GrapeExperimental Treatment2 Interventions

Participants consume 40 grams of placebo powder matching grape powder (dissolved into water) twice daily for 4 weeks. After a washout period of at least 4 weeks, participants then consume 40 grams of freeze-dried grape powder (dissolved into water) twice daily for 4 weeks.

Group II: Grape, Then PlaceboExperimental Treatment2 Interventions

Participants consume 40 grams of freeze-dried grape powder (dissolved into water) twice daily for 4 weeks. After a washout period of at least 4 weeks, participants then consume 40 grams of placebo powder matching grape powder (dissolved into water) twice daily for 4 weeks.

0 / 3Eligibility criteria met