HealthyNCT02999256
Effect of Cherry Juice on Fat Oxidation and Cardio-metabolic Markers
A study testing Montmorency Tart Cherry Juice in people with Healthy and Metabolic Syndrome, run by University of Hertfordshire.
Trial summary
The present study examined the effect of Montmorency tart cherry juice and FATMAX (intensity eliciting maximal fat oxidation) exercise on fat oxidation rates, body composition and blood-based cardio-metabolic markers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Metabolic Syndrome
- What is being tested?
- Montmorency Tart Cherry Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2016
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-45
- Male and Female
- Non-smokers
- Recreationally active (minimum 150 minutes physical activity per week)
- Injury free at all times of testing.
Who cannot join
- 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.
About this study
Official title: The Effect of Tart Cherry Juice Supplementation on Fat Oxidation, Body Composition and Cardio-Metabolic Markers With Cycling Exercise
The present study examined the effect of Montmorency tart cherry juice and FATMAX (intensity eliciting maximal fat oxidation) exercise on fat oxidation rates, body composition and blood-based cardio-metabolic markers. Participants received both Montmorency tart cherry juice and placebo in a random counterbalanced order for 20 days. Outcome variables were measured immediately pre- and post-supplementation and 10 days after the onset of supplementation. It was hypothesised that Montmorency tart cherry juice would increase fat oxidation during exercise, reduce body fat percentage and improve cardio-metabolic markers.
Read the 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.
- Conditions
- Healthy, Metabolic Syndrome
- Being tested
- Montmorency Tart Cherry Juice, Placebo
- Keywords
- Tart Cherry Juice, Fat Oxidation, Lipid Profile, Anthocyanins, Exercise, Calorie Restrictive Mimetic
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montmorency Tart Cherry JuiceDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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). Receives: Other: Placebo |
| Montmorency Tart Cherry Juice | Experimental | 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). Receives: Dietary Supplement: Montmorency Tart Cherry Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat Oxidation (grams/min)
Measured: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
Secondary outcomes (7)
Change in Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL) (mmol/L)
Measured: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
Change in Serum Glucose (mmol/L)
Measured: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
Change in Body Fat Percentage (%)
Measured: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
Change in Body Mass (kg)
Measured: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
Change in Fat Mass (kg)
Measured: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
Change in Fat Free Mass (kg)
Measured: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
Change in Total Antioxidant Status (mmol/L)
Measured: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hertfordshire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terun Desai, University of Hertfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999256
- Sponsor's protocol ID
- LMS/PGT/UH/02336_
- Status last verified
- Dec 2016
- First submitted
- 7 Dec 2016
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tart Cherry Juice Supplementation on Fat Oxidation, Body Composition and Cardio-Metabolic Markers With Cycling Exercise
- ClinicalTrials.gov ID
- NCT02999256
- Acronym / sponsor ID
- LMS/PGT/UH/02336_
- Conditions
- Healthy, Metabolic Syndrome
- Keywords
- Tart Cherry Juice, Fat Oxidation, Lipid Profile, Anthocyanins, Exercise, Calorie Restrictive Mimetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of HertfordshireUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Dec 2016 (estimated)
- 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 present study examined the effect of Montmorency tart cherry juice and FATMAX (intensity eliciting maximal fat oxidation) exercise on fat oxidation rates, body composition and blood-based cardio-metabolic markers. Participants received both Montmorency tart cherry juice and placebo in a random counterbalanced order for 20 days. Outcome variables were measured immediately pre- and post-supplementation and 10 days after the onset of supplementation. It was hypothesised that Montmorency tart cherry juice would increase fat oxidation during exercise, reduce body fat percentage and improve cardio-metabolic markers.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo130ml 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). |
| Montmorency Tart Cherry Juice | Experimental | Dietary Supplement: Montmorency Tart Cherry Juice130ml 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-45
- Male and Female
- Non-smokers
- Recreationally active (minimum 150 minutes physical activity per week)
- Injury free at all times of testing.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Montmorency Tart Cherry Juice | Dietary supplement | Montmorency Tart Cherry Juice |
| Placebo | Other | Placebo |
Primary outcome
Change in Fat Oxidation (grams/min)
Time frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
7 secondary outcomes
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
Change in Serum Glucose (mmol/L)
Time frame: 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
Change in Body Mass (kg)
Time frame: 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
Change in Fat Free Mass (kg)
Time frame: 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
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 21 Dec 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Montmorency Tart Cherry Juice in people with Healthy and Metabolic Syndrome, run by University of Hertfordshire.
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 5 inclusion and 4 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 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 in Fat Oxidation (grams/min) (time frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2016.