- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02999256
Effect of Cherry Juice on Fat Oxidation and Cardio-metabolic Markers
The Effect of Tart Cherry Juice Supplementation on Fat Oxidation, Body Composition and Cardio-Metabolic Markers With Cycling Exercise
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aims: (1) Examine whether tart cherry juice supplementation with cycling exercise augments fat oxidation rate and therefore plays a role in weight management in healthy active human participants. (2) To extrapolate findings from this study to future biomedical health and disease research.
Methods: Random counterbalanced, within-group, double-blind study design. Participants were randomly allocated into consuming either cherry juice first or placebo. Eleven recreationally active male and female participants were recruited. Participants consumed 30ml Montmorency tart cherry juice concentrate mixed with 100ml water, twice daily for 20 days. Participants underwent a 14 day washout period between trials. All participants were instructed to keep to their habitual intake of polyphenols and anthocyanins. Twenty-four hours before each exercise testing session, participants consumed similar meals at the same times. Diet adherence was monitored through food diaries.
Participants attended each testing session following an overnight fast, with the testing being completed at the same time in the morning to avoid circadian variation. Preliminary testing was conducted to ascertain VO2max and individual FATMAX, 4 days before the one hour pre-supplementation exercise test. VO2max was re-assessed 4 days before the one hour post-supplementation exercise test to determine if any changes in training status affected results.
Testing will occur at baseline, 10 days after the onset of supplementation and after 20 days supplementation. Exercise protocol consisted of 60min cycling at pre-determined individual FATMAX. Continuous gas analysis and heart rate were monitored throughout. Substrate oxidation rates and energy expenditure were calculated using stoichiometric equations (Jeukendrup and Wallis, 2005). During each testing session blood pressure and body composition (impedance) measurements were taken at baseline and pre-exercise during all testing sessions. Resting metabolic rate (indirect calorimetry) was assessed at baseline and pre-exercise during all testing sessions.
Serum blood samples were obtained from participants at the following time points: baseline, pre-exercise and post-exercise for one hour submaximal exercise tests, in both trials. The following markers were analysed: Glucose, Lactate, Triglycerides, HDL, Total Cholesterol and Total Antioxidant Status.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18-45
- Male and Female
- Non-smokers
- Recreationally active (minimum 150 minutes physical activity per week)
- Injury free at all times of testing.
Exclusion Criteria:
- Aged <18 years old, >45 years old
- Current or previous history of gastrointestinal, cardiovascular or renal disease
- Current or previous history of injury that may be exacerbated with the exercise protocol used
- Allergy to maltodextrin or specific fruit products (especially cherries) and those currently taking medication (such as steroids, NSAIDs, antibiotics) or currently using any nutritional supplement.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
130ml serving twice daily (immediately before breakfast and dinner) for 20 days. Placebo composition: Water (100ml), Cherry Squash Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml). |
|
|
Experimental: Montmorency Tart Cherry Juice
130ml serving twice daily (immediately before breakfast and dinner) for 20 days. MTCJ Composition: 100ml water and 30ml Montmorency tart cherry concentrate (Cherry Active, Sunbury, UK). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Fat Oxidation (grams/min)
Time Frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL) (mmol/L)
Time Frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
|
Change in Serum Glucose (mmol/L)
Time Frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
|
Change in Body Fat Percentage (%)
Time Frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
|
Change in Body Mass (kg)
Time Frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
|
Change in Fat Mass (kg)
Time Frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
|
Change in Fat Free Mass (kg)
Time Frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
|
Change in Total Antioxidant Status (mmol/L)
Time Frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMS/PGT/UH/02336_
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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