Fruit Consumption for Gut Health

Overseen By Shirin Hooshmand, PhD, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Must not be taking: Lipid reducers, Hypertension drugs, Psychiatric meds

Disqualifiers: Stroke, Myocardial infarction, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The objectives of this study are to investigate the effect of fruit consumption on the gut microbiota and their collective fecal and plasma metabolomes, vascular and cardiometabolic functions, cognition, and motor control.

Eligibility Criteria

This trial is for healthy men and women aged 30 to 70. It's not suitable for those with gastrointestinal, metabolic, or neurological disorders, a history of stroke or heart attack, or anyone on psychiatric meds or drugs for lipid reduction/hypertension.

Inclusion Criteria

I am between 30 and 70 years old and healthy.

Exclusion Criteria

I have been treated for high cholesterol or high blood pressure.

I have had a stroke or heart attack in the past.

I have a history of stomach or intestine problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume either 2 cup eq fruits per day or 1/2 cup eq fruits per day to assess the impact on gut microbiota and health outcomes

8 weeks

Baseline and 8-week visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fruit (2 cup eq)
• Fruit restriction (1/2 cup eq)

Trial Overview The study examines how eating different amounts of fruit affects gut health, blood markers, heart health, brain function (like thinking and movement). Participants will eat either 2 cups equivalent of fruit daily or restrict to half a cup.

Participant Groups

Group I: Fruits Experimental Treatment 1 Intervention

Participants will receive 2 cup eq fruits per day

Group II: Fruit restriction Experimental Treatment 1 Intervention

Participants will receive 1/2 cup eq fruits per day

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+