Impacts of Fruit on the Gut Health and Human Health

NCT ID: NCT05063929

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiometabolic Health Healthy Aging Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fruits

Participants will receive 2 cup eq fruits per day

Group Type EXPERIMENTAL

Fruit (2 cup eq)

Intervention Type OTHER

participants will receive 2 cup eq fruits

Fruit restriction

Participants will receive 1/2 cup eq fruits per day

Group Type OTHER

Fruit restriction (1/2 cup eq)

Intervention Type OTHER

participants will receive 1/2 cups eq fruits

Interventions

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Fruit (2 cup eq)

participants will receive 2 cup eq fruits

Intervention Type OTHER

Fruit restriction (1/2 cup eq)

participants will receive 1/2 cups eq fruits

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Diego State University

OTHER

Sponsor Role lead

Responsible Party

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Shirin Hooshmand

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shirin Hooshmand

San Diego, California, United States

Site Status

Countries

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United States

References

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Zingales S, Martinez J, Stepp AH, Miller C, Jason N, Hong MY, Liu C, Kern M, Hooshmand S. Daily Intake of Recommended Servings of Fruit Improves Nutrient Intake but Shows no Major - Effect on Cardiovascular Health or Cognition in Low Fruit Consumers. Curr Dev Nutr. 2025 Sep 3;9(10):107544. doi: 10.1016/j.cdnut.2025.107544. eCollection 2025 Oct.

Reference Type DERIVED
PMID: 41081007 (View on PubMed)

Other Identifiers

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5A297A

Identifier Type: -

Identifier Source: org_study_id

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