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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how different supplements, such as hydrolyzed collagen, PrimaColl (a type of collagen supplement), and whey protein, affect collagen production in the body. The goal is to determine which supplement, if any, increases collagen production when combined with vitamin C and exercise. This could improve skin, joint health, and overall recovery. Healthy, active individuals with a normal weight who are not taking conflicting medications may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding how supplements can enhance health and recovery.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that hydrolyzed collagen is generally safe. Studies have found it does not cause skin irritation or allergic reactions. Some individuals might experience mild digestive issues, such as diarrhea, but this is uncommon.

PrimaColl, a vegan collagen, is recognized by the FDA as safe, meeting strict safety standards. It contains no animal products, which some individuals might prefer.

Whey protein is also well-tolerated and commonly used in supplements for muscle building. It is considered safe, but excessive intake can sometimes cause digestive problems or allergies, especially in those sensitive to dairy.

Overall, these treatments are considered safe, with only minor potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for enhancing collagen synthesis because they offer a variety of innovative approaches. PrimaColl is notable for being a vegan collagen supplement, which is a unique option for those seeking plant-based solutions. Unlike traditional collagen sources, PrimaColl is designed to provide similar benefits without animal-derived ingredients. Hydrolized collagen, on the other hand, offers a highly absorbable form of collagen that might boost the body's natural collagen production more effectively than standard protein supplements. Lastly, the inclusion of whey protein in the trial is intriguing because it combines protein with vitamin C to potentially enhance collagen synthesis, which is not typically the focus of standard whey protein supplements. Each treatment aims to offer a distinct pathway to potentially improve skin health and joint function.

What evidence suggests that this trial's treatments could be effective for enhancing collagen synthesis?

Research has shown that hydrolyzed collagen, which participants in this trial may receive, can increase skin elasticity and reduce joint pain, particularly in individuals with osteoarthritis. It also helps maintain skin hydration and reduces wrinkle depth. PrimaColl, another treatment option in this trial, is a vegan collagen designed to mimic natural collagen and has improved joint health and skin appearance. Whey protein, also tested in this trial, helps build and repair muscles, especially when combined with exercise. Each of these treatments has demonstrated benefits in their respective areas, suggesting they might enhance collagen production. ^{6 7 8 9 10}

Who Is on the Research Team?

Keith Baar, PhD

Principal Investigator

UC Davis

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

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Results. Improvements in skin moisturization, skin elasticity and wrinkle depth were measured in the participants taking the hydrolyzed collagen after 28 days.

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Hydrolyzed collagen: Exploring its applications in the food ...

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Joint studies showed pain reduction and improved mobility. Muscle studies were inconsistent, and bone studies had limitations. Collagen showed ...

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11. Sangsuwan et al. (2020) [16], Four-weeks daily intake of oral collagen hydrolysate results in improved skin elasticity, especially in sun ...

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Cocoyl Hydrolyzed Collagen Ingredients

TEA-Cocoyl Hydrolyzed Collagen was non-irritating to rabbit skin at a concentration of 10%, and was mildly/slightly irritating in 2 studies ...

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Collagen Protein, Hydrolyzed

Inhalation: No known hazard. Skin: No known hazard. Ingestion: May cause diarrhea. NFPA Ratings (704):. Health.

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In clinical studies, Hydrolyzed Collagen produced no skin irritation, sensi- tization, or indication of phototoxicity. On the basis of the available animal and ...

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Safety Data Sheet: Collagen hydrolyzates

Shall not be classified as a specific target organ toxicant (repeated exposure). Aspiration hazard. Shall not be classified as presenting an aspiration hazard.

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Conclusions: CollaSel Pro® HCP can be considered a well-tolerated, safe product that effectively improves dermal health and the appearance of ...