Contact information
Type
Scientific
Primary contact
Dr Jay Udani
ORCID ID
Contact details
Medicus Research LLC
18250 Roscoe Blvd.
Suite 240
Northridge
91325
United States of America
+1 818 882 9442
jay.udani@medicusresearch.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MANN1001
Study information
Scientific title
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Delayed onset muscle soreness (DOMS)
Intervention
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
Drug
Phase
Not Specified
Drug names
BounceBack™
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
01/12/2007
Overall trial end date
30/04/2008
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
10
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
01/12/2007
Recruitment end date
30/04/2008
Locations
Countries of recruitment
United States of America
Trial participating centre
Medicus Research LLC
Northridge
91325
United States of America
Sponsor information
Organisation
Mannatech, Inc (USA)
Sponsor details
600 S. Royal Lane
Suite 200
Coppell
75019
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Mannatech, Inc (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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