PrimaColl + Whey Protein for Collagen Synthesis Enhancement

Overseen By Keith Baar, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Any interfering medications

Disqualifiers: Musculoskeletal injuries, dietary restrictions, others

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if taking different types of collagen or protein supplements with vitamin C helps the body make more collagen. Healthy young adults aged 18-30 will take these supplements and do exercises. The study will measure how much new collagen is made to see if these supplements can help reduce injuries to ligaments, tendons, and bones. Collagen peptide supplements have been shown to improve body composition and strength when paired with resistance training.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking any medication that may interfere with the study.

What data supports the effectiveness of the treatment PrimaColl + Whey Protein for enhancing collagen synthesis?

Research shows that hydrolyzed collagen can improve joint pain and skin quality, while whey protein can boost collagen production in skin cells. This suggests that PrimaColl + Whey Protein might help enhance collagen synthesis. ^{1 2 3 4 5}

Is PrimaColl + Whey Protein safe for human use?

Studies show that collagen hydrolysate and whey protein, components of PrimaColl, are generally safe for human use. Collagen hydrolysate has been used safely in studies for joint pain, and whey protein has been evaluated as safe by the European Food Safety Authority for various uses, including in infants and toddlers. ^{1 6 7 8 9}

How does the treatment PrimaColl + Whey Protein differ from other treatments for collagen synthesis enhancement?

PrimaColl + Whey Protein is unique because it combines hydrolyzed collagen, which is broken down into smaller peptides for better absorption, with whey protein to potentially enhance collagen synthesis. This combination may offer improved bioavailability and effectiveness compared to using collagen or whey protein alone. ^{10 11 12 13 14}

Research Team

Keith Baar, PhD

Principal Investigator

UC Davis

Eligibility Criteria

This trial is for healthy, active men and women with a normal weight (BMI between 18-25). Participants should not have dietary restrictions affected by supplements, more than three muscle or bone injuries in the past year, or be on medication that could interfere with the study.

Inclusion Criteria

You are a healthy and physically active male or female.

You have a healthy weight, meaning your body mass index (BMI) is between 18 and 25 kg/m2.

Exclusion Criteria

You have any health or diet restrictions that would prevent you from following the supplement plan.

You have had more than three injuries to your bones, muscles, or joints in the past year.

You are currently taking medication that could affect the study results.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Baseline blood draw and initial supplementation

1 day

1 visit (in-person)

Supplementation and Exercise

Participants consume supplements and perform jump rope exercise three times over a 24-hour period

1 day

1 visit (in-person), 2 optional visits (in-person or remote)

Follow-up

Participants are monitored for collagen synthesis through blood draws

4 hours after last exercise bout

1 visit (in-person)

Treatment Details

Interventions

• Hydrolized Collagen
• Placebo
• PrimaColl
• Whey protein

Trial Overview The study tests how different supplements affect collagen production when taken before exercise. It compares vitamin C enriched hydrolyzed collagen, PrimaColl™, whey protein, and a placebo over a day with repeated doses and jump rope exercises.

Participant Groups

Group I: Whey Protein Experimental Treatment 1 Intervention

This arm will be given whey protein (20g with 50mg vitamin C)

Group II: PrimaColl Experimental Treatment 1 Intervention

This arm will be given PrimaColl, a vegan collagen supplementation (20g with 50mg vitamin C)

Group III: Hydrolized Collagen Experimental Treatment 1 Intervention

This arm will be given Hydrolized Collagen (20g with 50mg vitamin C)

Group IV: Placebo Placebo Group 1 Intervention

This arm will be given a placebo (20g maltodextrin with 50mg vitamin C)

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Geltor

Collaborator

Trials

1

Recruited

20+

Findings from Research

In a 6-month study involving 200 patients aged 50 and older with joint pain, collagen hydrolysate at 1200 mg/day significantly increased the percentage of clinical responders (51.6%) compared to placebo (36.5%), indicating its potential efficacy in improving joint pain.

No significant safety or tolerability issues were reported between the collagen hydrolysate and placebo groups, suggesting that the supplement is safe for use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of collagen hydrolysate in articular pain: a 6-month randomized, double-blind, placebo controlled study. Bruyère, O., Zegels, B., Leonori, L., et al.[2022]

In a triple-blind study involving 60 healthy women over 12 weeks, a food supplement containing collagen peptides and vitamins significantly improved the collagen structure of facial skin compared to a placebo, as assessed by confocal laser scanning microscopy.

Participants also reported subjective improvements in skin elasticity, wrinkle appearance, and evenness across various body areas, indicating that the supplement is both effective and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Dermonutrient Containing Special Collagen Peptides Improves Skin Structure and Function: A Randomized, Placebo-Controlled, Triple-Blind Trial Using Confocal Laser Scanning Microscopy on the Cosmetic Effects and Tolerance of a Drinkable Collagen Supplement. Laing, S., Bielfeldt, S., Ehrenberg, C., et al.[2020]

A study identified 176 dietary supplements marketed for skin, hair, and nail health, revealing that most lack independent testing and often use outdated nutrient values.

Many of these products make health claims that are not verified by the FDA or rigorous clinical trials, highlighting the need for healthcare providers to educate patients about the reliability of such supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin, Hair, and Nail Supplements: Marketing and Labeling Concerns. Perez-Sanchez, AC., Tantry, EK., Burns, EK., et al.[2021]

The EFSA Panel concluded that whey basic protein isolate, derived from skimmed cow's milk, is safe for use in infant formula, meal replacements, and dietary supplements, with no safety concerns raised regarding its composition or production process.

The estimated intake levels for infants and toddlers (up to 27.8 mg/kg body weight per day) are considered safe, with sufficient margins of exposure indicating that it does not pose a nutritional disadvantage or genotoxicity risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Whey basic protein isolates as a novel food pursuant to Regulation (EU) 2015/2283. Turck, D., Bresson, JL., Burlingame, B., et al.[2023]

A 24-week randomized, placebo-controlled study involving 147 athletes showed that collagen hydrolysate significantly reduced activity-related joint pain compared to a placebo, indicating its potential efficacy in supporting joint health.

The study found that athletes taking collagen hydrolysate experienced notable improvements in joint pain during various activities, such as walking and standing, suggesting it may help maintain performance and reduce the risk of joint deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

24-Week study on the use of collagen hydrolysate as a dietary supplement in athletes with activity-related joint pain. Clark, KL., Sebastianelli, W., Flechsenhar, KR., et al.[2022]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Effect of collagen hydrolysate in articular pain: a 6-month randomized, double-blind, placebo controlled study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of a Hydrolyzed Collagen Supplement for Improving Skin Moisturization, Smoothness, and Wrinkles. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Low-molecular-weight whey proteins promote collagen production in dermal fibroblasts via the TGF-β receptor/Smad pathway. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A Dermonutrient Containing Special Collagen Peptides Improves Skin Structure and Function: A Randomized, Placebo-Controlled, Triple-Blind Trial Using Confocal Laser Scanning Microscopy on the Cosmetic Effects and Tolerance of a Drinkable Collagen Supplement. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Enzymatic Hydrolysis of a Collagen Hydrolysate Enhances Postprandial Absorption Rate-A Randomized Controlled Trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Skin, Hair, and Nail Supplements: Marketing and Labeling Concerns. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A collagen hydrolysate/milk protein-blend stimulates muscle anabolism equivalently to an isoenergetic milk protein-blend containing a greater quantity of essential amino acids in older men. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of Whey basic protein isolates as a novel food pursuant to Regulation (EU) 2015/2283. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Optimization of dose of collagen hydrolysate to prevent UVB-irradiated skin damage. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Determination of Peptide Profile Consistency and Safety of Collagen Hydrolysates as Quality Attributes. [2020]

11. England pubmed.ncbi.nlm.nih.gov

24-Week study on the use of collagen hydrolysate as a dietary supplement in athletes with activity-related joint pain. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Isolation and characterization of fish scale collagen from tilapia (Oreochromis sp.) by a novel extrusion-hydro-extraction process. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Development of Low-Molecular Weight Collagen Peptide Complex with Glycosaminoglycan Components. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Analysis of native collagen monomers and oligomers by size-exclusion high-performance liquid chromatography and its application. [2003]