Turmeric and Exercise-Induced Muscle Damage and Oxinflammation

NCT04765527 | Completed

• 1 other identifier: 19-0294
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure the effect of using a turmeric-based supplement for 2-weeks on muscle damage and soreness that occur in the body after 90-minutes of exercise. Participants will first come to the human performance lab (HPL) for orientation and pre-study fitness tests including muscular fitness and body composition. Participants will be randomized to turmeric or placebo groups, and take 2 tablets of the supplements each day for the first two weeks. Participants will report back to the HPL on a Monday to engage in weight lifting and calisthenics for 90 minutes. Fitness tests (vertical jump, bench press, leg-back lift for strength, 30-second cycling sprint test) and blood samples will be given and collected before and after this exercise session. Participants will then come back to the HPL each morning, Tuesday through Friday, in the early morning to provide blood samples and retake the fitness tests. This study will entail seven HPL visits over a 3-week period.

Conditions

Muscular Injury

Keywords

turmeric; muscular strength; inflammation; exercise; oxidative stress

Outcome Measures

Primary Outcomes (1)

• Serum concentration of creatine kinase

  Muscle damage biomarker

  Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

Secondary Outcomes (12)

• Serum concentration of myoglobin

  Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

• Rating of Delayed onset of muscle soreness

  Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

• Plasma concentration of 4-hydroxynonenal (4HNE)

  Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

• Serum concentration of C-reactive protein

  Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

• Plasma concentration of IL-6

  Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

Study Arms (2)

Turmeric

EXPERIMENTAL

Dietary supplement, Turmeric Strength for Joint, containing turmeric root extract (with 350 mg curcumin), black pepper extract, boswellia gum resin extract, devil's claw root extract, and ginger root; 2 tablets each day in the morning prior to breakfast, 2 weeks, and Monday through Friday of exercise and recovery.

Dietary Supplement: Turmeric Strength for Joint

Placebo

PLACEBO COMPARATOR

Placebo tablets; 2 tablets each day in the morning prior to breakfast, 2 weeks, and Monday through Friday of exercise and recovery.

Dietary Supplement: Placebo

Interventions

Turmeric Strength for Joint DIETARY_SUPPLEMENT

Turmeric-based tablets

Also known as: Turmeric

Turmeric

Placebo DIETARY_SUPPLEMENT

Placebo tablets

Also known as: Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, ages 18-50 years.
• Non-smoker.
• Body mass index less than 35 kg/m2 (below moderate or severe obesity).
• Not engaged in regular resistance training (less than 3 sessions per week).
• Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, protein supplements, herbs, and medications that influence inflammation and immune function (especially Advil, Motrin, aspirin, and similar anti-inflammatory drugs) for the duration of the study. (You will review your supplement and medication use with the Research Manager during orientation).
• Categorized as "low risk" using the American College of Sports Medicine screening questionnaire.
• Generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis.

You may not qualify if:

• Inability to comply with study requirements.
• Engaged in regular resistance training (3 or more sessions per week, on average).
• Body weight below 110 pounds.
• Pregnant or breastfeeding.
• Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.
• Current diagnosis of cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).
• History of allergic reactions to turmeric, devil's claw, boswellia extract, or ginger extract.

Sponsors & Collaborators

• Appalachian State University: lead
• MegaFood: collaborator

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Inflammation; Motor Activity

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• David C Nieman, DrPH

  Appalachian State Univ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Coded, capsules
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel group

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: February 21, 2021
• Study Start: December 15, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)