Status:
COMPLETED
Effects of Protein Hydrolysate Supplement on Systemic Muscle Function Markers Following Resistance Type Exercise in Male Subjects
Lead Sponsor:
Nuritas Ltd
Conditions:
Muscle Injury
Eligibility:
MALE
30-45 years
Phase:
NA
Brief Summary
The effect of exercise on serum concentrations of creatine kinase (CK) and subsequent use of protein hydrolysate supplementation, Elio, to influence the expression of CK following resistance type exer...
Detailed Description
Following muscle injury or exertion, several muscle specific enzymes (CK, LDH), metabolites (Acylcarnitine, FFAs) and inflammatory cytokines (IL-6, CRP) display a temporal increase in expression over ...
Eligibility Criteria
Inclusion
- Participants agree to comply with study procedures
- Participants agree to abstain from taking additional supplements throughout the testing period, with particular emphasis placed upon protein-based products
- Participants agree to maintain their normal diet and exercise routine throughout the study
- BMI between 18.5 to 29.9 kg/m2
- Participants agree to refrain from consuming alcohol in the 48 hrs leading up to a test day
- Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
- Provide voluntary, written, informed consent to participate in the study.
- Refrain from any sort of exhaustive physical exercise from 48 hrs prior to each test.
- Healthy as determined by medical examination at screening visit
- Willingness to complete food diaries (including two weekdays and one weekend day the week before testing) dietary intake records shall be completed before and during the study
- Non-smoker
- Subjects must possess a smart phone
Exclusion
- .Alcohol or drug abuse in past year
- Participation in any other clinical trial in the last 3 months from time of randomisation
- Subject has a known allergy to the test material's active or inactive ingredients
- Subjects with unstable medical conditions
- Clinically significant abnormal laboratory results at screening
- Any complaints that could interfere with ability to exercise
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any co-morbidities interacting with mobility or muscle metabolism of the lower limbs (e.g., arthritis, spasticity/rigidity, all neurological disorders and paralysis)
- Creatine supplements, anticoagulants, corticosteroids, growth hormones, testosterone, immunosuppressants, or exogenous insulin over the previous six months
- Presence or history of neurological disorders or significant psychiatric illness
- 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
- Participation in resistance or aerobic exercise within 48 hours of Day 0, Day 4, Day 15 and Day 19 visits in this trial
- Have been in contact with a suspected or confirmed case of Covid-19 in the previous 14 days
- Are Hepatitis A or B positive, HIV positive or have had a sexual partner who is infected with hepatitis or HIV
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05367648
Start Date
September 24 2020
End Date
November 24 2020
Last Update
May 10 2022
Active Locations (1)
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1
Nuritas Ltd
Dublin, Leinster, Ireland, 2