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Not Applicable

Fruit Consumption for Gut Health

N/A
Waitlist Available
Research Sponsored by San Diego State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of drug treatment for lipid reduction or hypertension
History of stroke or myocardial infarction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, at 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of fruit consumption on various health measures.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves consuming fruit in controlled quantities, side effects may include changes in digestion like bloating or discomfort especially if one's usual diet differs significantly from the study requirements.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated for high cholesterol or high blood pressure.
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I have had a stroke or heart attack in the past.
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I have a history of neurological disorders like epilepsy or Parkinson's.
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I have a known metabolic disorder like liver, kidney issues, or diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, at 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, at 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in composition of bacterial fecal microbiome at 8 weeks
Secondary study objectives
Change from baseline in Vascular health at 8 weeks
Change from baseline in processing speed (cognition) at 8 weeks

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: FruitsExperimental Treatment1 Intervention
Participants will receive 2 cup eq fruits per day
Group II: Fruit restrictionExperimental Treatment1 Intervention
Participants will receive 1/2 cup eq fruits per day

Find a Location

Who is running the clinical trial?

San Diego State UniversityLead Sponsor
169 Previous Clinical Trials
114,834 Total Patients Enrolled
1 Trials studying Healthy Aging
40 Patients Enrolled for Healthy Aging

Media Library

Fruit (2 cup eq) (Not Applicable) Clinical Trial Eligibility Overview. Trial Name: NCT05063929 — N/A
Healthy Aging Clinical Trial 2023: Fruit (2 cup eq) Highlights & Side Effects. Trial Name: NCT05063929 — N/A
Fruit (2 cup eq) (Not Applicable) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05063929 — N/A
Healthy Aging Research Study Groups: Fruits, Fruit restriction
~9 spots leftby Nov 2025