Clinical trial NCT06465407: Collagen Protein Versus Placebo on Muscle Recovery
Official title: Effect of Collagen Protein Versus Placebo on Indirect Markers of Musculotendinous Unit Recovery Following Eccentric Plantar Flexor Exercise
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Calf muscle thickness
timeFrame: 5 days
Secondary outcomes:
measure: Achilles tendon thickness.
timeFrame: 5 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References: