Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Jay Udani


Contact details

Medicus Research LLC
18250 Roscoe Blvd.
Suite 240
United States of America
+1 818 882 9442

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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.

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Delayed onset muscle soreness (DOMS)


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



Not Specified

Drug names


Primary outcome measures

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 measures

The following were assessed at baseline (pre-exercise), and then at 6, 24, 48 and 72 hours post-exercise:
1. Inflammation
2. Muscle damage

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United States of America

Trial participating centre

Medicus Research LLC
United States of America

Sponsor information


Mannatech, Inc (USA)

Sponsor details

600 S. Royal Lane
Suite 200
United States of America

Sponsor type




Funder type


Funder name

Mannatech, Inc (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes