Effects of Grape Consumption on the Immune-Gut Axis in Obesity

University of Missouri (MU)

Status: Enrolling

Conditions: Obesity &Amp; Overweight

Treatments: Other: Freeze-dried grape powder; Other: Placebo powder

Study type: Interventional

Funder types: Other

Identifiers

NCT07231484

2128808

Details and patient eligibility

About

This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.

Full description

The study is a 12-wk randomized, controlled, crossover trial. Participants will be randomized to one of two intervention sequences, either consuming 48g/day of whole freeze-dried grape powder followed by an isocaloric placebo powder or consuming the placebo powder followed by the whole freeze-dried grape powder. Active intervention phases will be 4 weeks in duration followed by a 4-week washout period between treatments.

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 30-45 years
• Obesity with BMI of 30-45 kg/m2
• Willingness to consume study foods
• Consistent diet and activity patterns for 4 weeks
• Weight stable (<5kg change over last 3 months)
• Non-smoker > 1 year or more
• Not currently consuming an extremely healthy diet

Exclusion criteria

• Study food allergies
• Regular consumption of grapes or grape-derived products
• Gastrointestinal disease and/or bariatric surgery
• Uncontrolled hypertension and blood pressure >180/110
• Diabetes
• Clinical Depression
• Illicit drug use
• History of alcohol or drug abuse
• Recent use of medications that affect immune function (e.g., corticosteroids)
• Recent consumption of antibiotics, prebiotics, probiotics, symbiotics, or dietary supplements containing fiber or phytochemicals
• Pregnant or lactating individuals
• HIV positivity
• Recent start of medications that affect metabolism or appetite
• Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Sequence 1: Grape then Placebo

Experimental group

Description:

Whole freeze-dried grape powder for 4 weeks, 4-week washout, then isocaloric placebo powder for 4 weeks.

Treatment:

Other: Placebo powder

Other: Freeze-dried grape powder

Sequence 2: Placebo then Grape

Experimental group

Description:

Isocaloric placebo powder for 4 weeks, 4-week washout, then whole freeze-dried grape powder for 4 weeks.

Treatment:

Other: Placebo powder

Other: Freeze-dried grape powder