Recovery and Muscle Function After Supplementation With Turmeric

Pain Clinical Trial

— RECOFAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04946981
• Other study ID #: AFCRO-128
• Status: Completed
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: December 2022
• Source: Naturex SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Damage
• Muscle Soreness
• Myalgia
• Pain

Intervention

Dietary Supplement:
• Turmipure Gold®
TPG: Turmipure GOLD® - 1 capsule per day - as prescribed
• Placebo
Placebo: colored acacia gum - 1 capsule per day - as prescribed

Locations

Country	Name	City	State
Ireland	Atlantia Food Clinical Trials	Cork

Sponsors (2)

Lead Sponsor	Collaborator
Naturex SA	Atlantia Food Clinical Trials

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on Perceived Muscle Soreness	Perceived Muscle Soreness in quadriceps during squatting activities assessed by VAS (0-100 mm, after two tries)	72 hours
Secondary	Change on Muscle damage	Muscle damage assessed by circulating levels of Creatine kinase in blood samples	72 hours
Secondary	Change on Isometric Muscle function recovery	Muscle function recovery assessed on quadriceps muscular function during isometric contractions recording the torque (Nm) using Biodex	72 hours
Secondary	Change on Isokinetic Muscle function recovery	Muscle function recovery assessed on quadriceps muscular function during isokinetic extensions recording the torque (Nm) using Biodex	72 hours
Secondary	Change on Muscle power recovery	Muscle power recovery assessed by Peak power (Watts) using vertical jump tests (best performance and average of 3 tries)	72 hours
Secondary	Change on Muscle ROM recovery	Muscle ROM recovery assessed by Range Of Movement using a goniometer (knee flexion)	72 hours
Secondary	Change on Perceived wellness and well-being	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)	72 hours
Secondary	Change on Perceived exertion during exercise	Perceived exertion through breathing difficulty during exercise assessed by the Borg Rating of Perceived Exertion (0-10, 10 indicating maximal difficulty)	30 min