Impacts of Fruit on the Gut Health and Human Health

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiometabolic Health, Healthy Aging, Cognition

Intervention / Treatment
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* Other: Fruit (2 cup eq)
* Other: Fruit restriction (1/2 cup eq)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fruits<br>Participants will receive 2 cup eq fruits per day | Other: Fruit (2 cup eq)<br>* participants will receive 2 cup eq fruits<br>|
| Other: Fruit restriction<br>Participants will receive 1/2 cup eq fruits per day | Other: Fruit restriction (1/2 cup eq)<br>* participants will receive 1/2 cups eq fruits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in processing speed (cognition) at 8 weeks | using Pattern Comparison Processing Speed Test | At baseline, at 8 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolome, Microbiome, Cognition, Fruit intake