Impacts of Fruit on the Gut Health and Human Health

Sponsor

San Diego State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05063929

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiometabolic Health Healthy Aging Cognition	Other: Fruit (2 cup eq) Other: Fruit restriction (1/2 cup eq)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 15, 2021

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Mar 15, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in processing speed (cognition) at 8 weeks [At baseline, at 8 weeks]
using Pattern Comparison Processing Speed Test
Change from baseline in Vascular health at 8 weeks [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shirin Hooshmand	San Diego	California	United States	92182-7251

Sponsors and Collaborators

San Diego State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shirin Hooshmand, Professor, San Diego State University

ClinicalTrials.gov Identifier:

NCT05063929

Other Study ID Numbers:

5A297A

First Posted:

Oct 1, 2021

Last Update Posted:

May 9, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shirin Hooshmand, Professor, San Diego State University

Study Results

No Results Posted as of May 9, 2022