Delayed onset muscle soreness (DOMS) Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both males and females, age >=18 and 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain (Visual Analogue Scale [VAS]) and tenderness, assessed at baseline (pre-exercise), and then at 6, 24, 48 and 72 hours post-exercise. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following were assessed at baseline (pre-exercise), and then at 6, 24, 48 and 72 hours post-exercise: 1. Inflammation 2. Muscle damage | — |
Countries
United States of America