Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05427279
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2022-06-09
Brief Title:
Effects of Vitamin C Enriched Hydrolyzed Collagen PrimaColl Whey Protein or Placebo on Collagen Synthesis
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Investigating the Effects of 24-hours of Repeated Doses of Vitamin C Enriched Hydrolyzed Collagen PrimaColl Whey Protein or Placebo on Collagen Synthesis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effects of repeated dosing vitamin C enriched hydrolyzed collagen HC over a 24hr period compared to PrimaColl PC whey protein WP and placebo PL with prescribed exercise on collagen synthesis
To achieve this participants will consume a supplemental dose of HC 20g with 50mg vitamin C PC 20g with 50mg vitamin C whey protein 20g whey isolate with 50mg vitamin C or a placebo 20g maltodextrin with 50mg vitamin C 1hr prior to an exercise bout 6 minutes of jump rope this will be repeated three times over a 24h period
The amount of collagen protein synthesized will be indirectly measured by measuring pro-collagen type I N-terminal propeptide PINP in the serum before and 4hrs after the last exercise bout
To achieve this participants will consume a supplemental dose of HC 20g with 50mg vitamin C PC 20g with 50mg vitamin C whey protein 20g whey isolate with 50mg vitamin C or a placebo 20g maltodextrin with 50mg vitamin C 1hr prior to an exercise bout 6 minutes of jump rope this will be repeated three times over a 24h period
The amount of collagen protein synthesized will be indirectly measured by measuring pro-collagen type I N-terminal propeptide PINP in the serum before and 4hrs after the last exercise bout
Detailed Description:
The purpose of this study is to determine the effects of repeated dosing of vitamin C enriched hydrolyzed collagen HC over a 24hr period compared to PrimaColl PC whey protein WP and placebo PL with prescribed exercise on collagen synthesis
To achieve this participants will consume a supplemental dose of HC 20g with 50mg vitamin C PC 20g with 50mg vitamin C whey protein 20g whey isolate with 50mg vitamin C or a placebo 20g maltodextrin with 50mg vitamin C 1hr prior to exercise bouts 6 minutes of jump rope The amount of collagen protein synthesized will be indirectly measured by measuring procollagen type I N-terminal propeptide PINP in the serum before and 4hrs after the last exercise bout
It is expected that this project will determine whether greater increases in collagen synthesis are observed with repeated doses of HC and exercise compared with a single dose and exercise bout from previous research This study will also determine whether collagen synthesis is similarly stimulated with PrimaColl or whey protein Results from this study will help to better prescribe the use of dietary collagen and exercise training to improve collagen synthesis in healthy young people Improved collagen synthesis has the potential to decrease ligament tendon and bone injuries in the general and athletic populations
Male and female participants between the ages of 18-30 years of age will be enrolled in the study A randomized double-blind crossover design with neither the subjects nor the investigators knowing who is on which treatment HC PC WP or PL
I Baseline blood draw
The subjects will arrive in the laboratory following an overnight fast The antecubital vein will be cannulated and an initial 5 mL baseline blood sample will be collected
II Supplementation
After baseline blood draw subjects will be provided with a supplement as shown in the table below Subjects will be asked to consume the supplement that will be pre-mixed with 250 ml of water 60 min before the jump rope exercise This will be repeated 3 times separated by 12 hours over a 24h period
III Exercise
Sixty minutes after the ingestion of the supplement each participant will complete 6 minutes of jump rope This will be repeated on 3 occasions over a 24hr period Subjects will be asked to abstain from vigorous exercise during the 24hr period aside from the prescribed jump rope exercise
Subjects will be asked to ingest supplement and jump rope in lab for time point 1 Subjects will be given the option to ingest supplement and jump rope outside lab if more conducive to their scheduling restrictions at time points 2 and 3 blood draws are not required at these timepoints Subjects will be asked to return to the lab 4 hours after last jumping session for blood sampling
Blood draws for PNIP analysis
Blood samples 5 mL at different time points
Baseline 2 vials will be drawn 1 for PINP and the other for bioassays
1h after the first supplementation 1 vial will be drawn bioassay
4hrs post-exercise session number 3 the last vial will be drawn PINP Blood will be collected in 5 mL serum separating tubes and allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutes and the serum will be frozen and kept at -30C until processed PINP levels will be determined by electrochemiluminescence ECL Roche Diagnostics Indianapolis IN according to the manufacturers instructions The total number of blood draws will be 12 3 per intervention with 4 interventions Treatments will be randomized to avoid an order effect and a washout period of about 72h between trials will be used to minimize the effect of the previous treatment
To achieve this participants will consume a supplemental dose of HC 20g with 50mg vitamin C PC 20g with 50mg vitamin C whey protein 20g whey isolate with 50mg vitamin C or a placebo 20g maltodextrin with 50mg vitamin C 1hr prior to exercise bouts 6 minutes of jump rope The amount of collagen protein synthesized will be indirectly measured by measuring procollagen type I N-terminal propeptide PINP in the serum before and 4hrs after the last exercise bout
It is expected that this project will determine whether greater increases in collagen synthesis are observed with repeated doses of HC and exercise compared with a single dose and exercise bout from previous research This study will also determine whether collagen synthesis is similarly stimulated with PrimaColl or whey protein Results from this study will help to better prescribe the use of dietary collagen and exercise training to improve collagen synthesis in healthy young people Improved collagen synthesis has the potential to decrease ligament tendon and bone injuries in the general and athletic populations
Male and female participants between the ages of 18-30 years of age will be enrolled in the study A randomized double-blind crossover design with neither the subjects nor the investigators knowing who is on which treatment HC PC WP or PL
I Baseline blood draw
The subjects will arrive in the laboratory following an overnight fast The antecubital vein will be cannulated and an initial 5 mL baseline blood sample will be collected
II Supplementation
After baseline blood draw subjects will be provided with a supplement as shown in the table below Subjects will be asked to consume the supplement that will be pre-mixed with 250 ml of water 60 min before the jump rope exercise This will be repeated 3 times separated by 12 hours over a 24h period
III Exercise
Sixty minutes after the ingestion of the supplement each participant will complete 6 minutes of jump rope This will be repeated on 3 occasions over a 24hr period Subjects will be asked to abstain from vigorous exercise during the 24hr period aside from the prescribed jump rope exercise
Subjects will be asked to ingest supplement and jump rope in lab for time point 1 Subjects will be given the option to ingest supplement and jump rope outside lab if more conducive to their scheduling restrictions at time points 2 and 3 blood draws are not required at these timepoints Subjects will be asked to return to the lab 4 hours after last jumping session for blood sampling
Blood draws for PNIP analysis
Blood samples 5 mL at different time points
Baseline 2 vials will be drawn 1 for PINP and the other for bioassays
1h after the first supplementation 1 vial will be drawn bioassay
4hrs post-exercise session number 3 the last vial will be drawn PINP Blood will be collected in 5 mL serum separating tubes and allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutes and the serum will be frozen and kept at -30C until processed PINP levels will be determined by electrochemiluminescence ECL Roche Diagnostics Indianapolis IN according to the manufacturers instructions The total number of blood draws will be 12 3 per intervention with 4 interventions Treatments will be randomized to avoid an order effect and a washout period of about 72h between trials will be used to minimize the effect of the previous treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None