Cardiometabolic HealthNCT05063929
Impacts of Fruit on the Gut Health and Human Health
A study testing Fruit (2 cup eq) and Fruit restriction (1/2 cup eq) in people with Cardiometabolic Health and Healthy Aging, run by San Diego State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Health, Healthy Aging, Cognition
- What is being tested?
- Fruit (2 cup eq) and Fruit restriction (1/2 cup eq)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women 30 to 70 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of the Impact of Fruit on the Gut Microbiota and Its Metabolites: Connections to 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.
Read the 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.
- Conditions
- Cardiometabolic Health, Healthy Aging, Cognition
- Being tested
- Fruit (2 cup eq), Fruit restriction (1/2 cup eq)
- Keywords
- Metabolome, Microbiome, Cognition, Fruit intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Fruits | Experimental | Participants will receive 2 cup eq fruits per day Receives: Other: Fruit (2 cup eq) |
| Fruit restriction | Other | Participants will receive 1/2 cup eq fruits per day Receives: Other: Fruit restriction (1/2 cup eq) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, at 8 weeks
Secondary outcomes (2)
Change from baseline in processing speed (cognition) at 8 weeks
using Pattern Comparison Processing Speed Test
Measured: 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.
Measured: At baseline, at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start15 Aug 2021
- Primary completion15 Aug 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic HealthStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirin Hooshmand, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063929
- Sponsor's protocol ID
- 5A297A
- Status last verified
- Dec 2024
- First submitted
- 25 Feb 2021
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41081007
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Impact of Fruit on the Gut Microbiota and Its Metabolites: Connections to Human Health
- ClinicalTrials.gov ID
- NCT05063929
- Acronym / sponsor ID
- 5A297A
- Conditions
- Cardiometabolic Health, Healthy Aging, Cognition
- Keywords
- Metabolome, Microbiome, Cognition, Fruit intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fruits | Experimental | Other: Fruit (2 cup eq)Participants will receive 2 cup eq fruits per day |
| Fruit restriction | Other | Other: Fruit restriction (1/2 cup eq)Participants will receive 1/2 cup eq fruits per day |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy men and women 30 to 70 years old
Key exclusion criteria (7 listed)
- History of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruit (2 cup eq)participants will receive 2 cup eq fruits | Other | Fruits |
| Fruit restriction (1/2 cup eq)participants will receive 1/2 cups eq fruits | Other | Fruit restriction |
Primary outcome
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.
2 secondary outcomes
Change from baseline in processing speed (cognition) at 8 weeks
Time frame: At baseline, at 8 weeks
Change from baseline in Vascular health at 8 weeks
Time frame: At baseline, at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Derived from this study: PubMed 41081007Zingales 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit (2 cup eq) and Fruit restriction (1/2 cup eq) in people with Cardiometabolic Health and Healthy Aging, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in composition of bacterial fecal microbiome at 8 weeks (time frame: At baseline, at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05063929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.