Evaluation of the Effects of a Novel Dietary Microalgae Based Ingredient on Muscle Recovery and Endurance Capacity

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: MicAlgae
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>2 capsules of Maltodextrin per day | Dietary Supplement: Placebo<br>* 2 months of supplementation with a placebo (Maltodextrin)<br>|
| Experimental: MicAlgae100<br>2 capsules per day containing 100mg of microalgae based ingredient | Dietary Supplement: MicAlgae<br>* 2 months of supplementation with an innovative microalgae based ingredient<br>|
| Experimental: MicAlgae250<br>2 capsules per day containing 250mg of microalgae based ingredient | Dietary Supplement: MicAlgae<br>* 2 months of supplementation with an innovative microalgae based ingredient<br>|
| Experimental: MicAlgae500<br>2 capsules per day containing 500mg of microalgae based ingredient | Dietary Supplement: MicAlgae<br>* 2 months of supplementation with an innovative microalgae based ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuromuscular function | isokinetic peak torque in Newton per meter (N/m) | From 0 to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy utilization (Oxygen consumption - VO2) | Running economy during a 5-minute run at 80% of the speed at VO2max with gaz exchange analyzis | From 0 to week 4 | 
| Energy utilization (Oxygen consumption - VO2) | Running economy during a 5-minute run at 80% of the speed at VO2max with gaz exchange analyzis | From 0 to week 8 | 
| Isokinetic neuromuscular function | peak torque in Newton per meter (N/m) | From 0 to week 8 | 
| Isometric neuromuscular function | peak torque in Newton per meter (N/m) | From 0 to week 8 | 
| Endurance capacity | Maximal oxygen consumption (VO2max) determined during graded exercise test | From 0 to week 4 | 
| Endurance capacity | Maximal oxygen consumption (VO2max) determined during graded exercise test | From 0 to week 8 | 
| Soreness and perceptual wellness | Evaluated using using a 100-point numerical pain rating scale anchored with 0= no pain to 100= the most intense pain sensation imaginable after exercise-induced muscle damage protocol | From 0 to week 4 | 
| Soreness and perceptual wellness | Evaluated using using a 100-point numerical pain rating scale anchored with 0= no pain to 100= the most intense pain sensation imaginable after exercise-induced muscle damage protocol | From 0 to week 8 | 
| Swelling - Muscle thickness (mm or cm) | Evaluated using musculoskeletal ultrasound | From 0 to week 4 | 
| Swelling - overall thigh circumference (mm or cm) | Evaluated using musculoskeletal ultrasound | From 0 to week 4 | 
| Creatine kinase (UI/I) | Blood marker analyzis | After 4 weeks of supplementation | 
| lactate dehydrogenase (U/L) | Blood marker analyzis | After 4 weeks of supplementation | 
| Myoglobin (ug/l) | Blood marker analyzis | After 4 weeks of supplementation | 
| Interleukin-6 (pg/ml) | Blood marker analyzis - inflammation | After 4 weeks of supplementation | 
| Tumor necrosis factor-α (ug/ml) | Blood marker analyzis - inflammation | After 4 weeks of supplementation | 
| C-reactive protein (mg/l) | Blood marker analyzis - inflammation | After 4 weeks of supplementation | 
| Isometric Neuromuscular function | Peak torque in Newton per meter (N/m) | From 0 to week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recovery, muscle endurance, exercise capacity, microalgae, inflammation