Improvements in muscle recovery and delayed onset muscle soreness (DOMS) reduction after eccentric exercise with the BounceBack™ product: a randomised, double-blind, two-way crossover, placebo-controlled, pilot study

ISRCTN	ISRCTN59915743
DOI	https://doi.org/10.1186/ISRCTN59915743
Protocol serial number	MANN1001
Sponsor	Mannatech, Inc (USA)
Funder	Mannatech, Inc (USA)

Submission date: 17/09/2008
Registration date: 09/10/2008
Last edited: 09/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jay Udani
Scientific

Medicus Research LLC
18250 Roscoe Blvd.
Suite 240
Northridge
91325
United States of America

Phone	+1 818 882 9442
Email	jay.udani@medicusresearch.com

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, placebo-controlled, two-way crossover, pilot trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The current study was designed to induce delayed onset muscle soreness (DOMS) in healthy untrained volunteers, assess the level of DOMS through functional and biochemical methods, and determine if the BounceBack™ product is superior to placebo in accelerating recovery from this condition.
Ethics approval(s)	This study was approved by Copernicus Group IRB on 11/02/2007.
Health condition(s) or problem(s) studied	Delayed onset muscle soreness (DOMS)
Intervention	The test product is BounceBack™, which contains enzymes, curcumin, vitamin C, avocado, soy extract and resveratrol. Dosage: BounceBack™ (oral) 1000 mg/day Schedule of interventions: Thirty days of consumption of the test product or placebo, followed by exercise on Day 31 and post-exercise evaluations on Day 32, 33 and 34. After a two-week washout period, the intervention was repeated in a crossover design.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	BounceBack™
Primary outcome measure(s)	Pain (Visual Analogue Scale [VAS]) and tenderness, assessed at baseline (pre-exercise), and then at 6, 24, 48 and 72 hours post-exercise.
Key secondary outcome measure(s)	The following were assessed at baseline (pre-exercise), and then at 6, 24, 48 and 72 hours post-exercise: 1. Inflammation 2. Muscle damage
Completion date	30/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	10
Key inclusion criteria	1. Both males and females, age >=18 and <=45 at screening 2. Body mass index (BMI) >18 kg/m^2 and <=30 kg/m^2 at screening 3. Recreationally active but non-resistance trained for the preceding 3 months 4. Agree to dietary modifications for the day prior to each visit 5. Subject agrees to all study visits 6. Must agree to use appropriate birth control methods during the active study
Key exclusion criteria	1. Non-compliance during the screening phase of the study 2. Weight loss of >10 pounds in the last 6 months 3. Pregnant or lactating 4. Currently attempting to become pregnant 5. Use of medications or supplements promoting weight gain (steroids, high-protein supplements) 6. Daily use of acid blocking medication. Must agree to withhold acid blocking medication while on study (Includes all prescription and over the counter acid blockers including PPIs, H2RAs, and calcium carbonate [Tums]). 7. Cigarette smoking 8. Abnormal physical examination 9. Subjects unable to understand or follow the study protocol 10. Subjects participating or participated in another clinical trial during the 1 month prior to screening 11. Subjects with active eating disorder including anorexia nervosa, bulimia, restrained eating, and/or obsessive compulsive eating disorders (Subjects will be screened with a standardised eating disorder questionnaire) 12. Subjects with known sensitivities to the ingredients in the product 13. Subjects with untreated significant depression or other psychiatric disease noted during the initial screening. Subjects with stable depression who are receiving medication and/or therapy may be included. 14. Subjects with active coronary artery disease, congestive heart failure, stroke, arrhythmia, or uncontrolled hypertension 15. Any liver, gallbladder or renal disease 16. Subjects with a history of seizure 17. Subjects with any cancer in the last 5 years (except skin cancer) 18. Subjects on anticoagulation therapy 19. Subjects with known alcohol abuse or recreational drug abuse 20. Subjects with chronic malabsorption 21. Subjects with a history of diverticulosis or diverticulitis 22. Subjects with inflammatory bowel disease (ulcerative colitis or Crohn's disease) 23. Subjects with a history of intestinal obstruction or those prone to intestinal obstruction 24. Subjects with short bowel syndrome 25. Subjects with a history of any surgery on their gastro-intestinal system 26. Subjects with a history of perforation of the stomach or intestines 27. Subjects with a history of pancreatitis, pancreatic insufficiency, pancreatic psuedocyst, carcinoma of the pancreas 28. Type I or type II diabetes 29. Subjects with any other endocrinologic disorders (including Cushing's syndrome and/or hypothyroidism) 30. Subjects with a history of lactic acidosis 31. Subjects with a history of symptomatic hypoglycemia 32. Subjects with brain and/or spinal cord injury 33. Subjects who have had diarrhoea in the month prior to the screening visit
Date of first enrolment	01/12/2007
Date of final enrolment	30/04/2008

Locations

Countries of recruitment

United States of America

Study participating centre

Medicus Research LLC

Northridge
91325
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan