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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2021
CompletedStudy Start
First participant enrolled
August 15, 2021
CompletedFirst Posted
Study publicly available on registry
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 8, 2025
December 1, 2024
2 years
February 25, 2021
January 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change from baseline in processing speed (cognition) at 8 weeks
At baseline, at 8 weeks
Change from baseline in Vascular health at 8 weeks
At baseline, at 8 weeks
Study Arms (2)
Fruits
EXPERIMENTALParticipants will receive 2 cup eq fruits per day
Fruit restriction
OTHERParticipants will receive 1/2 cup eq fruits per day
Interventions
Eligibility Criteria
You may qualify if:
- Healthy men and women 30 to 70 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shirin Hooshmand
San Diego, California, 92182-7251, United States
Related Publications (1)
Zingales S, Martinez J, Stepp AH, Miller C, Jason N, Hong MY, Liu C, Kern M, Hooshmand S. Daily Intake of Recommended Servings of Fruit Improves Nutrient Intake but Shows no Major - Effect on Cardiovascular Health or Cognition in Low Fruit Consumers. Curr Dev Nutr. 2025 Sep 3;9(10):107544. doi: 10.1016/j.cdnut.2025.107544. eCollection 2025 Oct.
PMID: 41081007DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 25, 2021
First Posted
October 1, 2021
Study Start
August 15, 2021
Primary Completion
August 15, 2023
Study Completion
December 31, 2024
Last Updated
January 8, 2025
Record last verified: 2024-12