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Clinical Trials/NCT05760742
NCT05760742CompletedNot Applicable

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

Microphyt1 site in 1 country80 target enrollmentStarted: January 10, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Microphyt
Enrollment
80
Locations
1
Primary Endpoint
Neuromuscular function

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Placebo group

Placebo Comparator

2 capsules of Maltodextrin per day

Intervention: Placebo (Dietary Supplement)

MicAlgae100

Experimental

2 capsules per day containing 100mg of microalgae based ingredient

Intervention: MicAlgae (Dietary Supplement)

MicAlgae250

Experimental

2 capsules per day containing 250mg of microalgae based ingredient

Intervention: MicAlgae (Dietary Supplement)

MicAlgae500

Experimental

2 capsules per day containing 500mg of microalgae based ingredient

Intervention: MicAlgae (Dietary Supplement)

Outcomes

Primary Outcomes

Neuromuscular function

Time Frame: From 0 to week 4

isokinetic peak torque in Newton per meter (N/m)

Secondary Outcomes

  • Energy utilization (Oxygen consumption - VO2)(From 0 to week 8)
  • Isometric neuromuscular function(From 0 to week 8)
  • Endurance capacity(From 0 to week 8)
  • Swelling - Muscle thickness (mm or cm)(From 0 to week 4)
  • Tumor necrosis factor-α (ug/ml)(After 4 weeks of supplementation)
  • Swelling - overall thigh circumference (mm or cm)(From 0 to week 4)
  • Myoglobin (ug/l)(After 4 weeks of supplementation)
  • Interleukin-6 (pg/ml)(After 4 weeks of supplementation)
  • Creatine kinase (UI/I)(After 4 weeks of supplementation)
  • C-reactive protein (mg/l)(After 4 weeks of supplementation)
  • Isometric Neuromuscular function(From 0 to week 4)
  • Isokinetic neuromuscular function(From 0 to week 8)
  • Soreness and perceptual wellness(From 0 to week 8)
  • lactate dehydrogenase (U/L)(After 4 weeks of supplementation)
  • Energy utilization (Oxygen consumption - VO2)(From 0 to week 4)
  • Endurance capacity(From 0 to week 4)
  • Soreness and perceptual wellness(From 0 to week 4)

Investigators

Sponsor
Microphyt
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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