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Completed

NCT Number: NCT04946981

Recovery and Muscle Function After Supplementation With Turmeric

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

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Key information

Age range

25 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Atlantia Food Clinical Trials

Cork, T23 R50R, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Hydrotherapy - cold water immersion, hot water immersion, or contrast therapy (as well as Jacuzzis, Steam baths, or Saunas)
  • Massage - self, foam rolling, etc.
  • Stretching
  • Compression garments
  • 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.

Treatment and study plan

Turmipure Gold®

Dietary Supplement

TPG: Turmipure GOLD® - 1 capsule per day - as prescribed

Placebo

Dietary Supplement

Placebo: colored acacia gum - 1 capsule per day - as prescribed

Primary outcomes

  1. Change on Perceived Muscle Soreness

    Time frame: 72 hours

    Perceived Muscle Soreness in quadriceps during squatting activities assessed by VAS (0-100 mm, after two tries)

Secondary outcomes

  1. Change on Muscle damage

    Time frame: 72 hours

    Muscle damage assessed by circulating levels of Creatine kinase in blood samples

  2. Change on Isometric Muscle function recovery

    Time frame: 72 hours

    Muscle function recovery assessed on quadriceps muscular function during isometric contractions recording the torque (Nm) using Biodex

  3. Change on Isokinetic Muscle function recovery

    Time frame: 72 hours

    Muscle function recovery assessed on quadriceps muscular function during isokinetic extensions recording the torque (Nm) using Biodex

  4. Change on Muscle power recovery

    Time frame: 72 hours

    Muscle power recovery assessed by Peak power (Watts) using vertical jump tests (best performance and average of 3 tries)

  5. Change on Muscle ROM recovery

    Time frame: 72 hours

    Muscle ROM recovery assessed by Range Of Movement using a goniometer (knee flexion)

  6. Change on Perceived wellness and well-being

    Time frame: 72 hours

    Perceived wellness and well-being is assessed by a psychometric test evaluating fatigue, sleep quality, general muscle soreness, stress, and mood (0-25, 25 indicating best feelings of wellness and well-being)

  7. Change on Perceived exertion during exercise

    Time frame: 30 min

    Perceived exertion through breathing difficulty during exercise assessed by the Borg Rating of Perceived Exertion (0-10, 10 indicating maximal difficulty)

Sponsors and collaborators

Lead sponsor

Givaudan France Naturals

Industry

Collaborators

  • Atlantia Food Clinical Trials

Registry information

Official study 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

Acronym: RECOFAST

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2021
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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