Anthropometrics: Height and WeightNCT06465407
Collagen Protein Versus Placebo on Muscle Recovery
A study testing Collagen and Maltodextrin in people with Anthropometrics: Height and Weight and Isometric Standing and Seated Plantarflexion, run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anthropometrics: Height and Weight, Isometric Standing and Seated Plantarflexion, Calf Muscle Thickness
- What is being tested?
- Collagen and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males between the ages of 18-30 years old
- Determined to be healthy by PAR-Q+ and the HHQ
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
David Fukuda, PhD, david.fukuda@ucf.edu
Katie Vasenina, M.S.
About this study
Official title: 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.
Read the 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.
- 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
- Being tested
- Collagen, Maltodextrin
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MaltodextrinDietary supplement
Participants will consume two 30-g amount of pure maltodextrin mixed in 300 ml of orange gatorade zero.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (1)
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anthropometrics: Height and WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ecaterina Vasenina, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465407
- Sponsor's protocol ID
- UCFlorida1
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Collagen Protein Versus Placebo on Indirect Markers of Musculotendinous Unit Recovery Following Eccentric Plantar Flexor Exercise
- ClinicalTrials.gov ID
- NCT06465407
- Acronym / sponsor ID
- UCFlorida1
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Collagen | Experimental | Dietary Supplement: CollagenCollagen 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 | Placebo comparator | Dietary Supplement: MaltodextrinPlacebo 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. |
| 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males between the ages of 18-30 years old
- Determined to be healthy by PAR-Q+ and the HHQ
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CollagenParticipants 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 | Collagen |
| MaltodextrinParticipants will consume two 30-g amount of pure maltodextrin mixed in 300 ml of orange gatorade zero. | Dietary supplement | Placebo |
Primary outcome
Calf muscle thickness
Time frame: 5 days
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.
1 secondary outcome
Achilles tendon thickness.
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen and Maltodextrin in people with Anthropometrics: Height and Weight and Isometric Standing and Seated Plantarflexion, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calf muscle thickness (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.