Collagen Protein Versus Placebo on Muscle Recovery

Effect of Collagen Protein Versus Placebo on Indirect Markers of Musculotendinous Unit Recovery Following Eccentric Plantar Flexor Exercise

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anthropometrics: Height and Weight; Isometric Standing and Seated Plantarflexion; Calf Muscle Thickness; Achilles Tendon Length and Thickness; Myotonography of the Calf Musculature and Achilles Tendon; Pain Pressure Threshold of the Calf; Pain Scale; Endurance Calf Test; Dietary Analysis
• Intervention / Treatment: Dietary supplement: Collagen; Dietary supplement: Maltodextrin

Detailed Description

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, will consume a daily dose of two 30-g amount of collagen peptides derived from bovine hide (commercially available as Vital Proteins or Peptan) or placebo (30 g of pure maltodextrin with no amino acids) mixed in 300 ml of orange Gatorade zero.

Gatorade zero, maltodextrin, and collagen is going to be stored in the locked cabinet in the lab. Research team will mix the supplement (placebo or maltodextrin) with Gatorade zero in a non-clear bottle and will administer it to the participants on-site.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • University of Central Florida
      • Contact: David Fukuda, PhD; Email: david.fukuda@ucf.edu
      • Principal Investigator: Katie Vasenina, M.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Untrained (no resistance training in the past 3 months)
• Any response of "yes" on the PAR-Q+; exclusion criteria noted on the HHQ
• Allergy to bovine collagen or maltodextrin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collagen; 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; 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.
Placebo Comparator: Placebo; 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; Participants will consume two 30-g amount of pure maltodextrin mixed in 300 ml of orange gatorade zero.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achilles tendon thickness.	Achilles tendon will be scanned using a B-mode US imaging device (GE Logiq e, GE Healthcare,Wauwatosa, WI, USA) and a multi-frequency linear-array probe (12 L-RS, 5-13 MHz, 38.4-mm field of view; GE Healthcare). The same researcher will perform the assessments. All ultrasound imaging analyses will be performed using Image-J software 1.8.0 (National Institute of Health, Bethesda, MD, USA). Achilles tendon length will be determined using the segmented line function between calcaneal notch and muscle-tendon junction along the midline of the Achilles tendon. Additionally, sagittal images of the Achilles tendon will be collected with the ankle passively dorsiflexed to approximately 90 degrees. Tendon thickness will be measured at reference point of 2 cm proximal to the superior aspect of the calcaneus.	5 days

Collaborators and Investigators

• Sponsor: University of Central Florida

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Osteochondrosis; Kyphosis; Scheuermann Disease; Spinal Osteochondrosis
• Other Study ID Numbers: UCFlorida1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No