Recovery and Muscle Function After Supplementation With Turmeric (RECOFAST)

Givaudan

Status: Completed

Conditions: Muscle Soreness; Muscle Damage; Pain

Treatments: Dietary Supplement: Turmipure Gold®; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04946981

AFCRO-128

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: Male

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups

Randomized Crossover_Sequence 1

Other group

Description:

Participants who meet the eligibility criteria will be randomized and will receive first the experimental product Turmipure GOLD® during the first study phase and then the placebo control during the second study phase. Both study phases are separated by a washout period of minimum 14 days.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Turmipure Gold®

Randomized Crossover_Sequence 2

Other group

Description:

Participants who meet the eligibility criteria will be randomized and will receive first the placebo control during the first study phase and then the experimental product Turmipure GOLD® during the second study phase. Both study phases are separated by a washout period of minimum 14 days.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Turmipure Gold®