Clinical trial NCT05760742: Evaluation of the Effects of a Novel Dietary Microalgae Based Ingredient on Muscle Recovery and Endurance Capacity
Official title: Evaluation of the Protective Effects of a Novel Dietary Microalgae Supplement (PeLiv) Following Exercise-induced Muscle Damage and Influence on Endurance Capacity After Prolonged Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: recovery
muscle endurance
exercise capacity
microalgae
inflammation
Lead sponsor: Microphyt
Sponsor class: INDUSTRY
Collaborators: name: University of Central Florida
First posted: 2023-03-08
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this investigation is to examine the effects of consuming a new dietary microalgae based supplement vs. placebo on neuromuscular function, energy utilization, soreness, perceptual wellness, swelling, and markers of muscle damage and inflammation in healthy young men before and after an acute exercise-induced muscle damage protocol (downhill running), and influence on endurance capacity after prolonged consumption.


Eligibility criteria: Inclusion Criteria:

* Male participants
* Healthy as assessed by Medical and activity history questionnaire (MHQ)
* Recreationally active according to American College of Sports Medicine guidelines
* Able to provide written and dated informed consent to participate in the study

Exclusion Criteria:

* Untrained
* Any response of "yes" on the PAR-Q+
* Physical limitations preventing running, countermovement jump, and strength (peak isometric torque and peak isokinetic torque) assessments

Primary outcomes:
measure: Neuromuscular function
timeFrame: From 0 to week 4
Secondary outcomes:
measure: Energy utilization (Oxygen consumption - VO2)
timeFrame: From 0 to week 4
measure: Energy utilization (Oxygen consumption - VO2)
timeFrame: From 0 to week 8
measure: Isokinetic neuromuscular function
timeFrame: From 0 to week 8
measure: Isometric neuromuscular function
timeFrame: From 0 to week 8
measure: Endurance capacity
timeFrame: From 0 to week 4
measure: Endurance capacity
timeFrame: From 0 to week 8
measure: Soreness and perceptual wellness
timeFrame: From 0 to week 4
measure: Soreness and perceptual wellness
timeFrame: From 0 to week 8
measure: Swelling - Muscle thickness (mm or cm)
timeFrame: From 0 to week 4
measure: Swelling - overall thigh circumference (mm or cm)
timeFrame: From 0 to week 4
measure: Creatine kinase (UI/I)
timeFrame: After 4 weeks of supplementation
measure: lactate dehydrogenase (U/L)
timeFrame: After 4 weeks of supplementation
measure: Myoglobin (ug/l)
timeFrame: After 4 weeks of supplementation
measure: Interleukin-6 (pg/ml)
timeFrame: After 4 weeks of supplementation
measure: Tumor necrosis factor-α (ug/ml)
timeFrame: After 4 weeks of supplementation
measure: C-reactive protein (mg/l)
timeFrame: After 4 weeks of supplementation
measure: Isometric Neuromuscular function
timeFrame: From 0 to week 4
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: David Fukuda, PhD
role: PRINCIPAL_INVESTIGATOR
References: