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Completed

NCT Number: NCT05063929

Impacts of Fruit on the Gut Health and Human Health

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.

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Key information

Conditions

Cardiometabolic Health Cognition Healthy Aging

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirin Hooshmand

San Diego, California, 92182-7251, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruit (2 cup eq)

Other

participants will receive 2 cup eq fruits

Fruit restriction (1/2 cup eq)

Other

participants will receive 1/2 cups eq fruits

Primary outcomes

  1. Change from baseline in composition of bacterial fecal microbiome at 8 weeks

    Time frame: 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 outcomes

  1. Change from baseline in processing speed (cognition) at 8 weeks

    Time frame: At baseline, at 8 weeks

    using Pattern Comparison Processing Speed Test

  2. Change from baseline in Vascular health at 8 weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 1, 2021
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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