NCT06465407

Brief Summary

This study is focused on exploring the gap in the literature by comparing the effects of collagen protein versus placebo supplementation on the musculotendinous unit following muscle damaging protocol. Thus, the purpose of this study is to identify and compare the effect of collagen protein versus placebo supplementation on indirect markers of musculotendinous unit recovery following eccentric calf exercises.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 13, 2024

Last Update Submit

June 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Calf muscle thickness

    Portable B-mode Ultrasound (GE Logiq e BT12, GE Healthcare, Milwaukee, WI, USA) and a multi-frequency linear- array probe (12 L-RS, 5-13 MHz, 38.4-mm field of view, GE Healthcare, Milwaukee, WI, USA) will be used to determine changes in muscle thickness of the randomized leg. The distance between the medial point of the knee joint space and the central point of the medial malleolus will be measured at 70% and ultrasound gel will be placed on this location prior to measurement. The highest and mean values of 3-5 measurements will be recorded for each assessment. All measurements will be done on one randomized leg.

    5 days

Secondary Outcomes (1)

  • Achilles tendon thickness.

    5 days

Study Arms (3)

Collagen

EXPERIMENTAL

Collagen supplementation group will have 12 participants. They will perform various physical assessments that include pain scale, pain pressure threshold assessment, body composition, calf circumference measurements, muscle thickness measurements, Achilles tendon length and thickness measurements, myotonography of the calf, isometric force assessments during standing and seated plantarflexion positions, a heel raise test, and a standardized exercise routine focused on eccentric movements, targeting a leg chosen at random. Additionally, they will consume a daily dose of two 30-g amount of collagen peptides derived from bovine hide (commercially available as Vital Proteins or Peptan).

Dietary Supplement: Collagen

Placebo

PLACEBO COMPARATOR

Placebo supplementation group will have 12 participants. They will perform various physical assessments that include pain scale, pain pressure threshold assessment, body composition, calf circumference measurements, muscle thickness measurements, Achilles tendon length and thickness measurements, myotonography of the calf, isometric force assessments during standing and seated plantarflexion positions, a heel raise test, and a standardized exercise routine focused on eccentric movements, targeting a leg chosen at random. Additionally, they will consume a daily dose of placebo (two 30 g of pure maltodextrin with no amino acids) mixed in 300 ml of orange Gatorade zero.

Dietary Supplement: Maltodextrin

Control

NO INTERVENTION

Control group (n=12) will receive no supplement. Control group participants will do all the assessments that the intervention participants are performing, except for the standardized exercise routine focused on the eccentric movements. Randomization will be performed via www.randomizer.org website.

Interventions

CollagenDIETARY_SUPPLEMENT

Participants will consume two 30-g amount of collagen peptides derived from bovine hide (commercially available as Vital Proteins or Peptan) mixed in 300 ml of orange gatorade zero.

Collagen
MaltodextrinDIETARY_SUPPLEMENT

Participants will consume two 30-g amount of pure maltodextrin mixed in 300 ml of orange gatorade zero.

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales between the ages of 18-30 years old
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males between the ages of 18-30 years old
  • Determined to be healthy by PAR-Q+ and the HHQ

You may not qualify if:

  • Untrained (no resistance training in the past 3 months)
  • Allergy to bovine collagen or maltodextrin

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

Body Weight

Interventions

Collagenmaltodextrin

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blind repeated measures design. Participants will be blinded to the intervention while research team will not be blinded and will be mixing supplements.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: This is a single blind repeated measures study design. There will be an intervention group and a control group. Intervention group is sub-divided into those who receive collagen (n=12) and those who receive placebo (n=12). The intervention group will perform every assessment including a standardized exercise routine focused on eccentric movements. Control group (n=12) will receive no supplement. Control group participants will do all the assessments that the intervention participants are performing, except for the standardized exercise routine focused on the eccentric movements. Randomization will be performed via www.randomizer.org website.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Research Associate

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 18, 2024

Study Start

July 1, 2024

Primary Completion

October 30, 2024

Study Completion

December 1, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations