NCT04946981

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

July 12, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

June 21, 2021

Last Update Submit

December 9, 2022

Conditions

Keywords

TurmericCurcuminoidsSport performance & recovery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change on Muscle damage

    72 hours

  • Change on Isometric Muscle function recovery

    72 hours

  • Change on Isokinetic Muscle function recovery

    72 hours

  • Change on Muscle power recovery

    72 hours

  • Change on Muscle ROM recovery

    72 hours

  • +2 more secondary outcomes

Study Arms (2)

Randomized Crossover_Sequence 1

OTHER

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.

Dietary Supplement: Turmipure Gold®Dietary Supplement: Placebo

Randomized Crossover_Sequence 2

OTHER

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.

Dietary Supplement: Turmipure Gold®Dietary Supplement: Placebo

Interventions

Turmipure Gold®DIETARY_SUPPLEMENT

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

Randomized Crossover_Sequence 1Randomized Crossover_Sequence 2
PlaceboDIETARY_SUPPLEMENT

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

Randomized Crossover_Sequence 1Randomized Crossover_Sequence 2

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantia Food Clinical Trials

Cork, T23 R50R, Ireland

Location

Related Publications (1)

  • Schonenberger KA, Laval J, Woods T, Truillet R, Naranjo-Modad S, Mettler S, Fanca-Berthon P. A randomized, placebo-controlled, crossover clinical trial to evaluate the effect of a turmeric formulation on muscle soreness and function recovery in moderately active adults. J Int Soc Sports Nutr. 2025 Dec;22(1):2568048. doi: 10.1080/15502783.2025.2568048. Epub 2025 Oct 3.

MeSH Terms

Conditions

MyalgiaPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Timothy Dinan, Professor

    Atlantia Food Clinical Trials

    PRINCIPAL INVESTIGATOR
  • Trevor Wood, PhD

    Sport Physiologist University College Cork

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2021

First Posted

July 1, 2021

Study Start

July 12, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Locations