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Recovery and Muscle Function After Supplementation With Turmeric (RECOFAST)

Primary Purpose

Muscle Soreness, Pain, Muscle Damage

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Turmipure Gold®
Placebo
Sponsored by
Naturex SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle Soreness focused on measuring Turmeric, Curcuminoids, Sport performance & recovery

Eligibility Criteria

25 Years - 45 Years (Adult)MaleAccepts 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.

Sites / Locations

  • Atlantia Food Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Randomized Crossover_Sequence 1

Randomized Crossover_Sequence 2

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change on Muscle damage
Muscle damage assessed by circulating levels of Creatine kinase in blood samples
Change on Isometric Muscle function recovery
Muscle function recovery assessed on quadriceps muscular function during isometric contractions recording the torque (Nm) using Biodex
Change on Isokinetic Muscle function recovery
Muscle function recovery assessed on quadriceps muscular function during isokinetic extensions recording the torque (Nm) using Biodex
Change on Muscle power recovery
Muscle power recovery assessed by Peak power (Watts) using vertical jump tests (best performance and average of 3 tries)
Change on Muscle ROM recovery
Muscle ROM recovery assessed by Range Of Movement using a goniometer (knee flexion)
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)
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)

Full Information

First Posted
June 21, 2021
Last Updated
December 9, 2022
Sponsor
Naturex SA
Collaborators
Atlantia Food Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT04946981
Brief Title
Recovery and Muscle Function After Supplementation With Turmeric
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Naturex SA
Collaborators
Atlantia Food Clinical Trials

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Soreness, Pain, Muscle Damage
Keywords
Turmeric, Curcuminoids, Sport performance & recovery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized Crossover_Sequence 1
Arm Type
Other
Arm 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.
Arm Title
Randomized Crossover_Sequence 2
Arm Type
Other
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Turmipure Gold®
Intervention Description
TPG: Turmipure GOLD® - 1 capsule per day - as prescribed
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo: colored acacia gum - 1 capsule per day - as prescribed
Primary Outcome Measure Information:
Title
Change on Perceived Muscle Soreness
Description
Perceived Muscle Soreness in quadriceps during squatting activities assessed by VAS (0-100 mm, after two tries)
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Change on Muscle damage
Description
Muscle damage assessed by circulating levels of Creatine kinase in blood samples
Time Frame
72 hours
Title
Change on Isometric Muscle function recovery
Description
Muscle function recovery assessed on quadriceps muscular function during isometric contractions recording the torque (Nm) using Biodex
Time Frame
72 hours
Title
Change on Isokinetic Muscle function recovery
Description
Muscle function recovery assessed on quadriceps muscular function during isokinetic extensions recording the torque (Nm) using Biodex
Time Frame
72 hours
Title
Change on Muscle power recovery
Description
Muscle power recovery assessed by Peak power (Watts) using vertical jump tests (best performance and average of 3 tries)
Time Frame
72 hours
Title
Change on Muscle ROM recovery
Description
Muscle ROM recovery assessed by Range Of Movement using a goniometer (knee flexion)
Time Frame
72 hours
Title
Change on Perceived wellness and well-being
Description
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)
Time Frame
72 hours
Title
Change on Perceived exertion during exercise
Description
Perceived exertion through breathing difficulty during exercise assessed by the Borg Rating of Perceived Exertion (0-10, 10 indicating maximal difficulty)
Time Frame
30 min

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Dinan, Professor
Organizational Affiliation
Atlantia Clinical Food Trials
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trevor Wood, PhD
Organizational Affiliation
Sport Physiologist University College Cork
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlantia Food Clinical Trials
City
Cork
ZIP/Postal Code
T23 R50R
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Recovery and Muscle Function After Supplementation With Turmeric

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