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
Secondary identifying numbers MANN1001
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

Study designRandomised, double-blind, placebo-controlled, two-way crossover, pilot trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectivesThe 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) studiedDelayed onset muscle soreness (DOMS)
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)BounceBack™
Primary outcome measurePain (Visual Analogue Scale [VAS]) and tenderness, assessed at baseline (pre-exercise), and then at 6, 24, 48 and 72 hours post-exercise.
Secondary outcome measuresThe following were assessed at baseline (pre-exercise), and then at 6, 24, 48 and 72 hours post-exercise:
1. Inflammation
2. Muscle damage
Overall study start date01/12/2007
Completion date30/04/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants10
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2007
Date of final enrolment30/04/2008

Locations

Countries of recruitment

  • United States of America

Study participating centre

Medicus Research LLC
Northridge
91325
United States of America

Sponsor information

Mannatech, Inc (USA)
Industry

600 S. Royal Lane
Suite 200
Coppell
75019
United States of America

Website http://www.mannatech.com
ROR logo "ROR" https://ror.org/031g1ba05

Funders

Funder type

Industry

Mannatech, Inc (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan