Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02999256
Other study ID # LMS/PGT/UH/02336_
Secondary ID
Status Completed
Phase N/A
First received December 7, 2016
Last updated December 16, 2016
Start date June 2016
Est. completion date December 2016

Study information

Verified date December 2016
Source University of Hertfordshire
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date December 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Montmorency Tart Cherry Juice

Other:
Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Hertfordshire

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Fat Oxidation (grams/min) Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms No
Secondary 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 No
Secondary Change in Serum Glucose (mmol/L) Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms No
Secondary Change in Body Fat Percentage (%) Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms No
Secondary Change in Body Mass (kg) Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms No
Secondary Change in Fat Mass (kg) Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms No
Secondary Change in Fat Free Mass (kg) Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms No
Secondary Change in Total Antioxidant Status (mmol/L) Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms No
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1