Clinical trial NCT04946981: Recovery and Muscle Function After Supplementation With Turmeric
Official title: A Placebo Controlled, Randomised, Crossover Clinical Trial to Evaluate the Effect of Turmipure Gold® in Muscle Pain and Function Recovery in Moderately Active Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Soreness
Pain
Muscle Damage
Keywords: Turmeric
Curcuminoids
Sport performance & recovery
Lead sponsor: Givaudan France Naturals
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
First posted: 2021-07-01
Enrollment: 45
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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


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:

  1. Hydrotherapy - cold water immersion, hot water immersion, or contrast therapy (as well as Jacuzzis, Steam baths, or Saunas)
  2. Massage - self, foam rolling, etc.
  3. Stretching
  4. Compression garments
  5. Topical applications - Tiger Balm, Deep Heat etc.

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
* Any previous or current cancer diagnosis (including a benign or malign tumour of intestine or colon)
* Current illnesses which could interfere with the study (e.g., prolonged severe diarrhoea, regurgitation/severe, difficulty swallowing)
* Known allergy to components of the test product or sensitivity to herbal products or with a medical history of food allergies
* Participants taking any anticoagulant or heparin treatment (including aspirin)
* Clinically significant abnormal laboratory results at screening
* Participant currently involved in any other clinical trial or having participated in a trial within 90 days prior to randomisation.
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
* History of non-compliance with medical treatments or recommendations.
* Participants who are required to perform squatting motions or descend a lot of stairs in their daily work activities, which may be painful following the Exercise Induced Muscle Damage.

Primary outcomes:
measure: Change on Perceived Muscle Soreness
timeFrame: 72 hours
Secondary outcomes:
measure: Change on Muscle damage
timeFrame: 72 hours
measure: Change on Isometric Muscle function recovery
timeFrame: 72 hours
measure: Change on Isokinetic Muscle function recovery
timeFrame: 72 hours
measure: Change on Muscle power recovery
timeFrame: 72 hours
measure: Change on Muscle ROM recovery
timeFrame: 72 hours
measure: Change on Perceived wellness and well-being
timeFrame: 72 hours
measure: Change on Perceived exertion during exercise
timeFrame: 30 min
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials
Study officials:
affiliation: Atlantia Clinical Food Trials
name: Timothy Dinan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sport Physiologist University College Cork
name: Trevor Wood, PhD
role: PRINCIPAL_INVESTIGATOR
References: