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Effect of Cherry Juice on Fat Oxidation and Cardio-metabolic Markers

Primary Purpose

Healthy, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Montmorency Tart Cherry Juice
Placebo
Sponsored by
University of Hertfordshire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Tart Cherry Juice, Fat Oxidation, Lipid Profile, Anthocyanins, Exercise, Calorie Restrictive Mimetic

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Montmorency Tart Cherry Juice

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    Change in Fat Oxidation (grams/min)

    Secondary Outcome Measures

    Change in Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL) (mmol/L)
    Change in Serum Glucose (mmol/L)
    Change in Body Fat Percentage (%)
    Change in Body Mass (kg)
    Change in Fat Mass (kg)
    Change in Fat Free Mass (kg)
    Change in Total Antioxidant Status (mmol/L)

    Full Information

    First Posted
    December 7, 2016
    Last Updated
    December 16, 2016
    Sponsor
    University of Hertfordshire
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02999256
    Brief Title
    Effect of Cherry Juice on Fat Oxidation and Cardio-metabolic Markers
    Official Title
    The Effect of Tart Cherry Juice Supplementation on Fat Oxidation, Body Composition and Cardio-Metabolic Markers With Cycling Exercise
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Hertfordshire

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy, Metabolic Syndrome
    Keywords
    Tart Cherry Juice, Fat Oxidation, Lipid Profile, Anthocyanins, Exercise, Calorie Restrictive Mimetic

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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).
    Arm Title
    Montmorency Tart Cherry Juice
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Montmorency Tart Cherry Juice
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Change in Fat Oxidation (grams/min)
    Time Frame
    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
    Secondary Outcome Measure Information:
    Title
    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
    Title
    Change in Serum Glucose (mmol/L)
    Time Frame
    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
    Title
    Change in Body Fat Percentage (%)
    Time Frame
    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
    Title
    Change in Body Mass (kg)
    Time Frame
    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
    Title
    Change in Fat Mass (kg)
    Time Frame
    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
    Title
    Change in Fat Free Mass (kg)
    Time Frame
    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
    Title
    Change in Total Antioxidant Status (mmol/L)
    Time Frame
    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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    Effect of Cherry Juice on Fat Oxidation and Cardio-metabolic Markers

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