Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201708002490201 Date of Approval: 02/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Natural Cocoa Powder Drink and Muscle Soreness after Exercise
Official scientific title The Effects of Natural Cocoa Powder on Recovery and Adaptation to Exercise-induced Muscle Injury
Brief summary describing the background and objectives of the trial Exercise-induced muscle injury (EIMI) is inevitable in sedentary individuals from novel exercise performance and even individuals in excellent athletic condition may experience muscle damage and soreness when performing exercises that are new to them. The muscle injury elicits inflammatory or immune response, induction of oxidative stress and electrolyte imbalance. These explain the signs and symptoms of EIMI and directly impact recovery from the injury as well as adaptation to such injurious exercises subsequently. A range of recovery strategies are being used in an attempt to reduce the deleterious consequences of damaging exercise; but studies in these areas have produced conflicting results. Notwithstanding the health benefits of natural cocoa powder (NCP) intake and the proposed mechanisms, its effect as recovery intervention and adaptation in EIMI has not been studied.Oral supplementation with antioxidants to attenuate exercise-induced inflammation has been studied. For instance, Vitamin C has generated the greatest interest for its potential influence on immune function and host¿s defense. However, Studies on vitamin C supplementation in attenuating exercise-induced inflammatory response and oxidative stress have reported conflicting findings. The natural cocoa powder contains polyphenols, which are beneficial compounds found in many fruits, vegetables, teas and wines. The polyphenols (flavanols) have potent antioxidant properties and are also known to exert anti-inflammatory effects.In addition, they are rich in electrolytes, which may improve electrolyte homeostasis in EIMI. Therefore, the objective of this study is to investigate the effects of pre and post-eccentric exercise intake of natural cocoa powder drink on adaptation and recovery from exercise-induced muscle injury.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Exercise-induced muscle injury, muscle soreness, adaptation,Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 04/09/2017
Actual trial start date 14/09/2017
Anticipated date of last follow up 15/11/2017
Actual Last follow-up date 30/11/2017
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants) 72
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
CHS-Et/M.9-P3.3/2015-2016 College of Health Sciences Ethical and Protocol Review Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1: Pre- and Post-Eccentric Exercise Intake of natural cocoa powder (NCP) 8% NCP ingestion 7 days before and after exercise Pre and post-exercise ingestion of natural cocoa powder 18 Placebo
Experimental Group Group 2: Pre-Eccentric Exercise Intake of NCP Group 8% NCP ingestion 7 days before and after exercise only pre-exercise intake of NCP 18
Experimental Group Post-Exercise Intake of NCP Group 8% NCP ingestion 7 days before and after exercise only post exercise intake of NCP 18
Control Group Non-intake of NCP group unrestricted water intake 7 days before and after exercise water intake 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects will be included in the study based on the following: (1) Subjects must maintain the usual normal activities of daily living, (2) Subjects who are not involved in any exercise or have not performed any exercise for the past six (6) months prior to the study especially, eccentric exercises of the lower extremities such as downhill running either overground or on treadmill, running or walking down stairs, jumping or weight training. (3) Subjects must be medically and physically fit and must be without any medical history for which the exercise protocol is contraindicated. Thus, potential participants will complete a health history questionnaire. In addition, a medical doctor will examine participants in order to include eligible ones. (4) Subjects must be between 18 and 30 years. (5) Subjects should have normal resting CK levels Subjects will be excluded based on the following: (1) Subjects who are already involved in structured exercise programmes or have been involved in eccentrically-biased lower limb exercises prior to the study, (2) Subjects with anemia, musculoskeletal limitations, known inflammatory conditions, diabetes, heart disease, known kidney problems, smoking, chronic use of anti-inflammatory medications (including over-the-counter nonsteroidal anti-inflammatory drugs), pregnancy or any other conditions or medications for which exercise is contraindicated. (3) Subjects with abnormal resting levels of the biochemical markers of muscle damage, immune function, oxidative stress and electrolyte balance. (4) Subjects taking natural cocoa powder as beverage or on any anti-oxidant or anti-inflammatory supplements. 18 Year(s) 30 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/05/2016 College of Health Sciences Ethical and Protocol Review Committee, University of Ghana
Ethics Committee Address
Street address City Postal code Country
Korle-Bu Accra 52 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Plasma markers of muscle injury: creatine kinase, lactate dehydrogenase Baseline and 1, 24, 48, 72, 96 and 120 hours
Primary Outcome Physical markers of muslce injury: perceived muscle soreness rating, muscle strength, muscle circumference, knee and hip range of motions Baseline and 1, 24, 48, 72, 96 and 120 hours
Primary Outcome Inflammatory markers of muscle injury: Plasma IL-6, TNF-¿, and IL-10 Baseline and 1, 24, 48, 72, 96 and 120 hours
Primary Outcome oxidative stress markers: Malondialdehyde (MDA), superoxide dismutase (SOD), glutathione (GPX) and total antioxidant capacity (TAC) Baseline and 1, 24, 48, 72, 96 and 120 hours
Primary Outcome Electrolytes: plasma levels of Na+, K+, Ca2+, Mg2+ , Cl- and H+ Baseline and 1, 24, 48, 72, 96 and 120 hours
Secondary Outcome Full blood count Baseline and 120 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle-Bu Community Hospital Road Accra KB 143 Ghana
Korle Gonno Community Hospital Road Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
N/A N/A N/A N/A
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor N/A N/A N/A N/A Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr. Daniel A. Antwi SBAH, CHS, University of Ghana, Korle-Bu Accra 143 Ghana
Dr. Bartholomew Ddzudzor SBAH, CHS, University of Ghana, Korle-Bu Accra 143 Ghana
Mr. Emmanuel Bonney SBAH, CHS, University of Ghana, Korle-Bu Accra 143 Ghana
Dr John Ahenkorah SBAH, CHS, University of Ghana, Korle-Bu Accra 143 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Frimpong frimemma@gmail.com +233204404865/ +27832065111 UHAS, Regional Hospital
City Postal code Country Position/Affiliation
Ho 31 Ghana Lecuturer/Department of Physiotherapy, Unversity of Health and Allied Sciences
Role Name Email Phone Street address
Public Enquiries Emmanuel Bonney ebonney10@gmail.com +233243936728 SBAHS, CHS, University of Ghana, Korle-Bu
City Postal code Country Position/Affiliation
Accra 143 Ghana Assistant Lecturer/Department of Physiotherapy, University of Ghana
Role Name Email Phone Street address
Scientific Enquiries John Ahenkorah daajonny@yahoo.com +233546232394 SBAHS, CHS, University of Ghana, Korle-Bu
City Postal code Country Position/Affiliation
Accra 143 Ghana Senior Lecuturer/Department of Anatomy, SBAHS, University of Ghana
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information