Impacts of Fruit on the Gut Health and Human Health

Healthy Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05063929
• Other study ID #: 5A297A
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Health
• Cognition
• Healthy Aging

Intervention

Other:
• Fruit (2 cup eq)
participants will receive 2 cup eq fruits
• Fruit restriction (1/2 cup eq)
participants will receive 1/2 cups eq fruits

Locations

Country	Name	City	State
United States	Shirin Hooshmand	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in composition of bacterial fecal microbiome 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	Change from baseline in processing speed (cognition) at 8 weeks	using Pattern Comparison Processing Speed Test	At baseline, at 8 weeks
Secondary	Change from baseline in Vascular health 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