Impacts of Fruit on the Gut Health and Human Health

Not Applicable

Completed

• Conditions: Cognition; Cardiometabolic Health; Healthy Aging
• Interventions: Other: Fruit (2 cup eq); Other: Fruit restriction (1/2 cup eq)

• Registration Number: NCT05063929
• Lead Sponsor: San Diego State University

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.

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 Timeline

• Study First Submitted: 2021-02-25
• Study Start: 2021-08-15
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-01
• Primary Completion: 2023-08-15
• Status Verified: 2024-12
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fruits	Fruit (2 cup eq)	Participants will receive 2 cup eq fruits per day
Fruit restriction	Fruit restriction (1/2 cup eq)	Participants will receive 1/2 cup eq fruits per day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Change from baseline in processing speed (cognition) at 8 weeks	At baseline, at 8 weeks	using Pattern Comparison Processing Speed Test

Trial Locations

Locations (1)

Shirin Hooshmand; 🇺🇸 San Diego, California, United States