Influence of high dose cocoa-flavanol intake on factors affecting exercise performance and recovery

ISRCTN ISRCTN14438374
DOI https://doi.org/10.1186/ISRCTN14438374
Secondary identifying numbers CFEX
Submission date
21/11/2016
Registration date
28/04/2017
Last edited
28/04/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Cocoa flavanols (CF) are a supplement made from cocoa beans. They have several beneficial health effects and can stimulate blood flow to provide the body with sufficient oxygen and nutrients when exercising. After exercise, the body needs to recover. The aim of this study is to find out whether taking this CF supplement can help to improve exercise performance and help recovery from exercise.

Who can participate?
Well-trained male cyclists aged 20 to 35

What does the study involve?
Participants undergo a cycling test on the first occasion. On two separate occasions, participants undergo two 30-min all-out cycling exercises (time trials), 1.5 and 3 hours after taking either CF or a placebo (dummy supplement), with a rest in between. Blood samples are taken at the start of the study and before and after each time trial and tested for several markers.

What are the possible benefits and risks of participating?
The possible benefits include improved performance and recovery from exercise. The study does not involve any risks, as the participants are used to heavy exercise and perform cycling training at least 10 hours per week.

Where is the study run from?
Vrije Universiteit Brussel (Belgium)

When is the study starting and how long is it expected to run for?
March 2015 to July 2015

Who is funding the study?
Vrije Universiteit Brussel (Belgium)

Who is the main contact?
Lieselot Decroix

Contact information

Mrs Lieselot Decroix
Scientific

Department of Human Physiology, VUB
Pleinlaan 2
Brussel
1050
Belgium

Study information

Study designRandomized double-blind interventional placebo-controlled cross-over single-centre study
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Community
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEffect of acute cocoa flavanols intake on exercise-induced oxidative stress, inflammation and nitric oxide production in healthy athletes: a randomized controlled trial
Study objectivesIt is hypothesized that cocoa flavanol (CF) intake:
1. Will have little or no effect on indirect markers of NO production and exercise performance in healthy, well-trained, subjects
2. Will decrease exercise-induced oxidative stress and inflammation, leading to an improved recovery
Ethics approval(s)Medical ethics committee UZ Brussel-VUB, 28/01/2015, ref: B.U.N. 143201523265
Health condition(s) or problem(s) studiedExercise performance and recovery
InterventionParticipants perform an incremental cycling test on the first occasion. On two separate occasions, subjects perform two 30-min time trials on an indoor cycle-ergometer, interposed by passive rest, 1.5 and 3 hours after drinking a single dose of either:
1. Chocolate drink with high cocoa flavanol content (900 mg flavanols) (brandname: acticoa)
2. Placebo chocolate drink (13 mg flavanols)
The drinks are matched in caffeine, theobromine, calories, carbohydrates, fat and proteins.

Lactate, glucose, heart rate, rating of perceived exertion (RPE) and power output were measured during the time trials. Blood will be drawn at baseline and before and after each time trial and analyzed for several markers.
Intervention typeSupplement
Primary outcome measure1. Epicatechin serum concentration
2. Trolox equivalent antioxidative capacity (TEAC)
3. Uric acid (UA) plasma concentration
4. Malonaldehyde (MDA) plasma concentration
5. L-arginine/ADMA plasma concentration
6. Citrulline plasma concentration
7. Interleukin (IL)-1 plasma concentration
8. IL-6 plasma concentration
9. Tumor necrosis factor (TNF)-α plasma concentration
Measured at baseline and before and after each time trial (pre-TT1, post-TT1, pre-TT1, post-TT1) by HPLC, ELISA and spectrophotometry of plasma and serum (blood)
Secondary outcome measures1. Time trial performance; time to complete a certain predefined workload during time trial 1 (90-120 min after cocoa intake) and during time trial 2 (210-240 min after cocoa intake)
2. Physiological parameters during time trial:
2.1. Lactate concentration, glucose concentration and rate of perceived exertion at start, after 10 min, after 20 min and at the end of each time trial
2.2. Heart rate and power output at start, after 5, 10, 15, 20, 25 mintues and at the end of each time trial
Overall study start date01/03/2015
Completion date01/07/2015

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexMale
Target number of participants15
Key inclusion criteria1. Age: between 20 years and 35 years
2. No severe head injuries in the past
3. No intake of neurological or psychological medication
4. Healthy
5. No hypertension
6. No cardiovascular disease
7. Cycling training of at least 10 hours per week for the last 2 years
Key exclusion criteria1. Age: younger than 20 years or older than 35 years
2. Severe head injuries in the past
3. Intake of neurological or psychological medication which might alter cognitive function (psychotropic drugs, beta adrenergic blockers, steroids)
4. Hypertension
5. Cardiovascular disease
6. Other diseases which can alter cognitive function (diabetes, depression)
Date of first enrolment15/03/2015
Date of final enrolment01/05/2015

Locations

Countries of recruitment

  • Belgium

Study participating centre

Vrije Universiteit Brussel
1050
Belgium

Sponsor information

Vrije Universiteit Brussel
University/education

Pleinlaan 2
Brussels
1050
Belgium

ROR logo "ROR" https://ror.org/006e5kg04

Funders

Funder type

University/education

Vrije Universiteit Brussel

No information available

Results and Publications

Intention to publish date01/12/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe data will be presented in a peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Lieselot Decroix.