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| 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 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | MANN1001 |
| Study hypothesis | 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. |
| Lay summary | |
| Ethics approval | This study was approved by Copernicus Group IRB on 11/02/2007. |
| Study design | Randomised, double-blind, placebo-controlled, two-way crossover, pilot trial |
| Countries of recruitment | United States of America |
| Disease/condition/study domain | Delayed onset muscle soreness (DOMS) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/12/2007 |
| Anticipated end date | 30/04/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 10 |
| Interventions |
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. |
| 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. |
| 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 |
| Sources of funding | Mannatech, Inc (USA) |
| Trial website | |
| Publications | |
| Contact name | Dr Jay Udani |
| Address |
Medicus Research LLC
18250 Roscoe Blvd. Suite 240 |
| City/town | Northridge |
| Zip/Postcode | 91325 |
| Country | United States of America |
| Tel | +1 818 882 9442 |
| Fax | +1 818 479 9373 |
| jay.udani@medicusresearch.com | |
| Sponsor | Mannatech, Inc (USA) |
| Address |
600 S. Royal Lane
Suite 200 |
| City/town | Coppell |
| Zip/Postcode | 75019 |
| Country | United States of America |
| Sponsor website: | http://www.mannatech.com |
| Date applied | 17/09/2008 |
| Last edited | 09/10/2008 |
| Date ISRCTN assigned | 09/10/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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