Impacts of Fruit on the Gut Health and Human Health

December 12, 2023 updated by: Shirin Hooshmand, San Diego State University

An Investigation of the Impact of Fruit on the Gut Microbiota and Its Metabolites: Connections to Human Health

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The Investigators findings will provide data critical to the understanding of the effects of fruit intake on the gut microbiome and the capacity of the microbiota to biotransform nutrients contained within fruits as well as the subsequent impact on circulating status of those metabolites. Concurrently, health outcomes that may be linked to these changes including cognition, motor control, vascular function and cardiometabolic health risk markers will be assessed in healthy adults.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92182-7251
        • Shirin Hooshmand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy men and women 30 to 70 years old

Exclusion Criteria:

  • History of:

    • stroke or myocardial infarction
    • gastrointestinal disorders
    • neurological disorders (epilepsy, multiple sclerosis, Parkinson's disease, stroke, etc)
    • known metabolic disorders (liver, renal or clinically diagnosed diabetes)
    • drug treatment for lipid reduction or hypertension,
    • psychiatric medication use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fruits
Participants will receive 2 cup eq fruits per day
Other: Fruit (2 cup eq)
participants will receive 2 cup eq fruits
Other: Fruit restriction
Participants will receive 1/2 cup eq fruits per day
Other: Fruit restriction (1/2 cup eq)
participants will receive 1/2 cups eq fruits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in composition of bacterial fecal microbiome at 8 weeks
Time Frame: At baseline, at 8 weeks
Bacterial fecal microbiome 16S rRNA gene amplicon libraries will be sequence using the Illumina MiSeq next generation sequencing platform.
At baseline, at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in processing speed (cognition) at 8 weeks
Time Frame: At baseline, at 8 weeks
using Pattern Comparison Processing Speed Test
At baseline, at 8 weeks
Change from baseline in Vascular health at 8 weeks
Time Frame: At baseline, at 8 weeks
To better understand how changes in the gut microbiota through fruit consumption are linked to changes in health outcomes, we will assess endothelial function via flow-mediated vasodilation and risk factors for cardiometabolic dysfunction in fasting blood samples collected at baseline and after 8 weeks.
At baseline, at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Actual)

August 15, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5A297A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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