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Impacts of Fruit on the Gut Health and Human Health

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05063929
Enrollment
40
Registered
2021-10-01
Start date
2021-08-15
Completion date
2024-12-31
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiometabolic Health, Cognition, Healthy Aging

Keywords

Metabolome, Microbiome, Cognition, Fruit intake

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.

Interventions

OTHERFruit (2 cup eq)

participants will receive 2 cup eq fruits

OTHERFruit restriction (1/2 cup eq)

participants will receive 1/2 cups eq fruits

Sponsors

San Diego State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in composition of bacterial fecal microbiome at 8 weeksAt baseline, at 8 weeksBacterial fecal microbiome 16S rRNA gene amplicon libraries will be sequence using the Illumina MiSeq next generation sequencing platform.

Secondary

MeasureTime frameDescription
Change from baseline in processing speed (cognition) at 8 weeksAt baseline, at 8 weeksusing Pattern Comparison Processing Speed Test
Change from baseline in Vascular health at 8 weeksAt baseline, at 8 weeksTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026