A Placebo Controlled, Randomised, Crossover Clinical Trial to Evaluate the Effect of Turmipure Gold® in Muscle Pain and Function Recovery in Moderately Active Adults

Givaudan France Naturals1 site in 1 country45 target enrollmentJuly 12, 2021

ConditionsMuscle Soreness Pain Muscle Damage

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Muscle Soreness
Sponsor: Givaudan France Naturals
Enrollment: 45
Locations: 1
Primary Endpoint: Change on Perceived Muscle Soreness
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study is to test the capacity of a five-day supplementation of Turmipure Gold® to improve exercise-induced muscle pain and function recovery in moderately active adults after exercise-induced muscle damage

Registry

clinicaltrials.gov

Start Date

July 12, 2021

End Date

April 1, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Givaudan France Naturals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy free-living males
•Age: 25-45 years old
•Have a BMI between 18.5 and 28 kg/m²
•Moderately active with running 15-20 km per week
•With 1 to 4h of training per week, with maximum 1h of lower body heavy-load or resistance training (e.g., Hill running or hiking, HIT exercise, Squats, Lunges, Leg-press, Bench steps, etc.)
•Consent to the study protocol and to comply with study product
•Willing to limit caffeine, smoking, and alcohol consumption during the entire study period with no more than 5 cigarettes per day and 2 drinks. Also, alcohol consumption will not be allowed 24hours prior to exercise-induced muscular damage
•Willing to refrain from training for 3 days before the first test, 5 days before each damage-inducing exercise and during each supplementation phase, including active recovery exercises such as swimming, cycling at low intensity, unusual distance walking (however such should be encouraged during the 14 days wash-out)
•Willing to refrain the use of anti-inflammatory/pain reliever drugs such as paracetamol, NSAIDs, etc., during each supplementation phase, from 24 hours prior to 72 hours following the exercise-induced muscular damage
•Willing to refrain from 'recovery' treatments over the 72 hours following the damage inducing exercise such as:

Exclusion Criteria

•Participants with any indicators of arthritis, joint disorders chronic pain syndrome, muscle disorder diseases (e.g., fibromyalgia, etc.)
•History of surgery or significant injury in joints or in the lower limb in the last six months prior to study enrolment, or an anticipated need for surgical or invasive procedure that will be performed during the study
•Using omega-3-fatty acid, probiotic supplements, vitamins, minerals, or any dietary supplements (including botanicals), especially to maintain joint health 4 weeks prior to screening and during the entire study. Potential supplements include but are not limited to Beta-alanine, Creatine, HMB, Carnosine, Taurine, androstenedione, DHEA, Whey protein, or a pre-workout supplement
•Following any specific diet such as high-protein, vegetarian, vegan, etc
•Taking any drugs such as antibiotics, laxatives, or immunosuppressant drugs
•History of glucocorticoid injection or hyaluronic acid injections within 3 months prior to enrolment
•Participants near or in the peak of training for an athletic race (half or marathon, cycling tour or triathlon)
•History or current significant cardiovascular, pulmonary, renal, liver, digestive (including an inflammatory bowel disease), infectious disease, systemic disease, immune disorder, or metabolic/endocrine disorders (including diabetes mellitus) or other disease that would preclude supplement ingestion and/or assessment of study objectives, including uncontrolled hypertension, uncontrolled thyroidism or lipidaemia that is not on stable medication for at least 3 months.
•Participant has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements
•Participant with history of drug and / or alcohol abuse at the time of enrolment