Collagen Protein Versus Placebo on Muscle Recovery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 30 Years
Gender	Male

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06465407
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Central Florida
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Additional Details

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.

Arms & Interventions

Arms

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).

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.

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.

Interventions

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.

Dietary Supplement: - Maltodextrin

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Central Florida, Orlando, Florida

Status

Address

University of Central Florida

Orlando, Florida, 32816

Site Contact

David Fukuda, PhD

[email protected]

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