NCT02999256

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

3 months

First QC Date

December 7, 2016

Last Update Submit

December 16, 2016

Conditions

Keywords

Tart Cherry JuiceFat OxidationLipid ProfileAnthocyaninsExerciseCalorie Restrictive Mimetic

Outcome Measures

Primary Outcomes (1)

  • Change in Fat Oxidation (grams/min)

    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)

    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms

  • Change in Serum Glucose (mmol/L)

    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms

  • Change in Body Fat Percentage (%)

    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms

  • Change in Body Mass (kg)

    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms

  • Change in Fat Mass (kg)

    Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms

  • +2 more secondary outcomes

Study Arms (2)

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).

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).

Dietary Supplement: Montmorency Tart Cherry Juice

Interventions

Montmorency Tart Cherry Juice
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-45
  • Male and Female
  • Non-smokers
  • Recreationally active (minimum 150 minutes physical activity per week)
  • Injury free at all times of testing.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 21, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

December 21, 2016

Record last verified: 2016-12