- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07155915
- Original Trial
Effects of Cherry Consumption on Metabolic Health
Effects of Cherry Consumption on Metabolic Health: A Pilot Clinical Study on Healthy Adults
This study is designed to evaluate the effects of daily sweet cherry consumption on markers of metabolic health in adults. Cherries are rich in bioactive compounds, such as anthocyanins and phenolic acids, which may help reduce oxidative stress, inflammation, and early risk factors for conditions like type 2 diabetes and cardiovascular disease. Participants will consume 280 grams of fresh sweet cherries every day for 42 consecutive days. Blood and urine samples will be collected at four time points: before the intervention (baseline), at day 21, at day 42 (end of the intervention), and two weeks after stopping cherry consumption.
The study will measure changes in blood sugar regulation, markers of inflammation, oxidative stress, liver and kidney function, and immune response. Waist circumference and body mass index will also be recorded.
The aim of this study is to test whether daily cherry consumption can support metabolic health in healthy adults and to provide data that may inform larger and longer clinical trials in the future.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Guarda, Portugal
- Instituto Politécnico da Guarda
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-65 years old
- Healthy individuals with no known metaboli disorders
Exclusion Criteria:
- Alcohol consumption
- Smoking
- Adverse or allergic reaction to cherries
- Use of antibiotics, anxiolytics, or dietary supplements
- Pregnancy or lactation
- Weight changes greater than 10% in the previous year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Daily Sweet Cherry Consumption
Participants in this arm will consume 280 grams of fresh sweet cherries (Prunus avium, "Prime-Giant" variety) every day for 42 consecutive days.
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Participants will consume 280 grams of fresh sweet cherries daily for 42 consecutive days.
Cherries are provided in pre-weighed portions to be consumed in the morning on an empty stomach
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in fasting glucose
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in HbA1c
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in estimated average glucose
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in insulin
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in IL-6
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in AGP-1
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in C-reactive protein
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in gluthatione peroxidase
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in gluthatione reductase
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in glutamate dehydrogenase
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in aspartate aminotransferase
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in alanine transaminase
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in gamma-glutamyl transferase
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in total bilirubin
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in conjugated bilirubin
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in unconjugated bilirubin
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in lactate dehydrogenase
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in total proteins
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in albumin
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in urea
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in creatinine
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in microalbumin
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in uric acid
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in iron
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in TIBC
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in transferrin
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in ferritin
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in amylase
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in lipase
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in IgA
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in IgG
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in IgM
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in total IgE
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in rheumatoid factor
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in antistreptolysin O
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in triglycerides
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in total cholesterol
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in HDL cholesterol
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in LDL cholesterol
Time Frame: Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Baseline, Day 21, Day 42 and 2 weeks post-intervention
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Changes in waist circumference
Time Frame: Baseline and Day 42
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Baseline and Day 42
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Body Mass Index
Time Frame: Baseline and Day 42
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Baseline and Day 42
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PRR-C05-i03-I-000143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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