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

Completed

• Conditions: Musculoskeletal Diseases; Delayed onset muscle soreness (DOMS)

• Registration Number: ISRCTN59915743
• Lead Sponsor: Mannatech, Inc (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified