Collagen Vitamin C Dose Response Performance

NCT03293004 | Completed DMC

• 1 other identifier: 1042848
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Previous work has shown that gelatin supplementation could increase collagen synthesis in humans. In this study subjects consume placebo, 5 or 15 g of gelatin with a standard amount of vitamin C (48 mg) 1 hour before 6 minutes of jump rope exercise. The feeding and exercise intervention was repeated every 6 hours while the subjects were awake for three days and the amount of the amino terminal procollagen I peptide (PINP) was determined; a marker of collagen synthesis, in the blood. Consistent with the hypothesis that gelatin increases collagen synthesis in humans; the amount of PINP in the 15 g gelatin group was significantly higher than either the placebo or the 5 g groups. These data conclusively demonstrate that gelatin supplementation can increase exercise-induced collagen synthesis in humans. Hydrolyzed collagen has a similar amino acid profile, in particular with high concentrations of glycine, proline, hydroxyproline, and arginine. Thus the current study aims to precisely map out the dose response relationship of hydrolyzed collagen and vitamin C on PINP and to determine the optimal dose to achieve maximal increased in PINP levels.

Conditions

Healthy Volunteers

Keywords

collagen; tendon; procollagen type I N-terminal; athletes; vitamin C; hydrolyzed collagen

Outcome Measures

Primary Outcomes (2)

• PINP Levels

  To determine optimal dose of supplemental hydrolyzed collagen and vitamin C required to maximally elevate PINP levels (a marker of collagen synthesis) in healthy athletes.

  9 weeks

• Rate of force development (RFD)

  a measure of explosive strength

  3 weeks

Study Arms (4)

Hydrolyzed collagen

EXPERIMENTAL

First, we aim to determine the optimal amount of hydrolyzed collagen with a constant dose of vitamin C in humans to increase a marker of collagen synthesis (PINP). In a randomized, double-blinded, crossover design subjects consume a nutritional supplement with varying doses of hydrolyzed collagen (control (0 g), 5 10, 20 and 30 g hydrolyzed collagen) with a constant dose of vitamin C (50 mg). Each intervention will be separated by a 6-day wash out. Subjects will be asked to consume the supplement 1 hour before 6-min of jump rope exercise. Following completion of exercise, subjects will remain in the lab in a rested state for the subsequent 4 hours. After 4 hours and 24 hours blood samples will be collected. Blood samples will be used for PINP analysis.

Dietary Supplement: Hydrolyzed collagen

Vitamin C

EXPERIMENTAL

Second, we aim to determine the optimal amount of vitamin C with the determined optimal dose of hydrolyzed collagen in humans to increase a marker of collagen synthesis (PINP). In a randomized, double-blinded, crossover design subjects consume a nutritional supplement with varying doses of vitamin C (0 (control), 50, 250 and 500 mg) with an optimized dose of hydrolyzed collagen as determined from the first arm. Each intervention will be separated by a 6-day wash out. Subjects will be asked to consume the supplement 1 hour before 6-min of jump rope exercise. Following completion of exercise, subjects will remain in the lab in a rested state for the subsequent 4 hours. After 4 hours and 24 hours blood samples will be collected. Blood samples will be used for PINP analysis.

Dietary Supplement: Vitamin C

Optimized Collagen and Vitamin C supplement

EXPERIMENTAL

The findings from the first 2 arms of the study will be used to inform a training-based study aimed to determine whether exercise together with this optimal dose of hydrolyzed collagen and vitamin C is sufficient to improve rate of force development (RFD) and performance. A gummy food will be developed with the optimized dose of hydrolyzed collagen and vitamin C as well as a placebo. In a randomized, double-blinded, parallel design with subjects undertake a 3 week exercise protocol. The supplement will be ingested 1 hour prior to each exercise session (Monday/Wednesday/Friday). Exercise testing to assess rate of force development (RFD) will take place at the end of each week (Fridays) and these outcomes will be the basis for determining the effects of the nutrition intervention on performance.

Dietary Supplement: Optimized Hydrolyzed Collagen and Vitamin C

Gummy Placebo

PLACEBO COMPARATOR

A gummy food will be developed with the optimized dose of hydrolyzed collagen and vitamin C as well as a placebo. In a randomized, double-blinded, parallel design with subjects undertake a 3 week exercise protocol. The supplement or placebo will be ingested 1 hour prior to each exercise session (Monday/Wednesday/Friday). Exercise testing to assess rate of force development (RFD) will take place at the end of each week (Fridays) and these outcomes will be the basis for determining the effects of the nutrition intervention on performance.

Dietary Supplement: Gummy Placebo

Interventions

Hydrolyzed collagen DIETARY_SUPPLEMENT

Escalating dose of Hydrolyzed collagen

Hydrolyzed collagen

Vitamin C DIETARY_SUPPLEMENT

Escalating dose of Vitamin C

Vitamin C

Optimized Hydrolyzed Collagen and Vitamin C DIETARY_SUPPLEMENT

combination of optimized doses of Hydrolyzed Collagen and Vitamin C

Optimized Collagen and Vitamin C supplement

Gummy Placebo DIETARY_SUPPLEMENT

Gummy placebo

Gummy Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Male Then initial phases of this study will be performed in males since collagen synthesis varies significantly throughout the menstrual cycle in females. Since collagen in the main outcome measure for this study this natural variation would confound the initial phase of the work. • Provided this work proves successful then we will aim to perform similar studies in females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Collegiate level male athletes between 18 - 25 years of age
• Currently registered/participating as an intercollegiate athlete
• \< 3 musculoskeletal injuries in the past year
• No health or dietary restriction that would be affected by the supplementation protocol.

You may not qualify if:

• History of more than 3 musculoskeletal injuries within the past 12 months.
• Health, dietary restriction or diet that would be affected by the supplementation protocol.
• Then initial phases of this study will be performed in males since collagen synthesis varies significantly throughout the menstrual cycle in females. Since collagen in the main outcome measure for this study this natural variation would confound the initial phase of the work. Provided this work proves successful then we will aim to perform similar studies in females.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Davis, California, 95616, United States

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All nutritional interventions taste and look similar and are prepared for subjects in opaque bottles
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A double blinded cross over design where subject are randomized to consume all 5 intervention doses.

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 26, 2017
• Study Start: September 13, 2017
• Primary Completion: May 24, 2018
• Study Completion: May 24, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)