NCT05760742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

February 23, 2023

Last Update Submit

September 21, 2023

Conditions

Keywords

recoverymuscle enduranceexercise capacitymicroalgaeinflammation

Outcome Measures

Primary Outcomes (1)

  • Neuromuscular function

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

    From 0 to week 4

Secondary Outcomes (17)

  • Energy utilization (Oxygen consumption - VO2)

    From 0 to week 4

  • Energy utilization (Oxygen consumption - VO2)

    From 0 to week 8

  • Isokinetic neuromuscular function

    From 0 to week 8

  • Isometric neuromuscular function

    From 0 to week 8

  • Endurance capacity

    From 0 to week 4

  • +12 more secondary outcomes

Study Arms (4)

Placebo group

PLACEBO COMPARATOR

2 capsules of Maltodextrin per day

Dietary Supplement: Placebo

MicAlgae100

EXPERIMENTAL

2 capsules per day containing 100mg of microalgae based ingredient

Dietary Supplement: MicAlgae

MicAlgae250

EXPERIMENTAL

2 capsules per day containing 250mg of microalgae based ingredient

Dietary Supplement: MicAlgae

MicAlgae500

EXPERIMENTAL

2 capsules per day containing 500mg of microalgae based ingredient

Dietary Supplement: MicAlgae

Interventions

MicAlgaeDIETARY_SUPPLEMENT

2 months of supplementation with an innovative microalgae based ingredient

MicAlgae100MicAlgae250MicAlgae500
PlaceboDIETARY_SUPPLEMENT

2 months of supplementation with a placebo (Maltodextrin)

Placebo group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Fukuda, PhD

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 8, 2023

Study Start

January 10, 2023

Primary Completion

August 1, 2023

Study Completion

August 18, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations