Nutritional Supplement for Connective Tissue Health

Recruiting in Palo Alto (17 mi)

Overseen by Keith Baar, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

Trial Summary

What is the purpose of this trial?

This trial tests if a natural supplement can help the body make more collagen when taken with collagen protein. It targets people who want better skin, joint, or ligament health. The supplement works by boosting collagen production in the body.

Do I need to stop taking my current medications?

Yes, you must stop taking any medication that may interfere with the study outcomes.

What data supports the idea that Nutritional Supplement for Connective Tissue Health is an effective treatment?

The available research shows that collagen supplements can be effective for joint pain and skin health. In a study on joint pain, people taking collagen hydrolysate reported less pain compared to those taking a placebo. Another study found that collagen supplements improved skin elasticity and hydration, which are signs of healthier skin. These findings suggest that collagen supplements can help with joint pain and improve skin quality. ^{1 2 3 4 5}

What safety data exists for the nutritional supplement for connective tissue health?

The safety data for the nutritional supplement, often evaluated as collagen supplements, indicates that it is generally safe with no reported adverse events. Studies, including randomized, placebo-controlled trials, have shown that collagen supplementation is well-tolerated and does not cause significant adverse effects. The supplement has been used in various studies for joint pain, skin quality, and other dermatological applications, consistently demonstrating safety and good tolerance among participants. ^{1 3 5 6 7}

Is the treatment Natural Product Supplement a promising treatment for connective tissue health?

Yes, the Natural Product Supplement, which includes collagen, shows promise for connective tissue health. Studies suggest it can help reduce joint pain, improve skin elasticity, and support cartilage health. It is generally safe and may enhance collagen production, which is important for healthy skin and joints. ^{1 2 5 8 9}

Research Team

Keith Baar, PhD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for young healthy adults aged 18-35 who are not pregnant, do not smoke, and are not on medications that could affect the study results. It's designed to see if a new nutritional supplement can help the body make more collagen after taking collagen protein.

Inclusion Criteria

I am between 18 and 35 years old and healthy.

Exclusion Criteria

Pregnancy

Smoking

I am not on medications that could affect the study results.

Treatment Details

Interventions

• Natural Product Supplement (Other)
• Placebo control (Other)

Trial Overview Researchers are testing a natural product supplement against a placebo to see if it enhances collagen production in the body when taken with collagen protein. Participants' blood samples will be used to treat lab-grown ligaments and measure effects.

Participant Groups

Group I: Natural Product Supplement Experimental Treatment 1 Intervention

The participant will consume a dose of hydrolyzed collagen (20g) supplemented with vitamin C (100 mg), epicatechin (75 mg), vitamin E (350 iU) and stevia extract (225 mg).

Group II: Placebo Placebo Group 1 Intervention

The participant will consume a dose of hydrolyzed collagen (20g) supplemented with vitamin C (100 mg) and sweetener.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Rakesh Dixit

University of California, Davis

Chief Executive Officer since 2024

PhD in Biochemistry and Molecular Biology from the University of California, Davis

Suresh Mahabhashyam

University of California, Davis

Chief Medical Officer since 2020

MD from Bangalore Medical College

AmpHP, Inc

Collaborator

Trials

1

Recruited

20+

Findings from Research

A review of 11 randomized-controlled trials involving 805 patients indicates that collagen supplementation can significantly improve skin quality, including elasticity and hydration, over periods ranging from 4 to 24 weeks.

Collagen supplements are generally safe with no reported adverse events, suggesting they could be a beneficial option for treating skin aging and aiding in wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Collagen Supplementation: A Systematic Review of Dermatological Applications Choi, FD., Sung, CT., Juhasz, ML., et al.[2019]

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 randomized trial with 80 patients suffering from osteoarthritis, BioCell Collagen (BCC) significantly reduced joint pain and improved physical function compared to a placebo over 70 days.

The treatment was well tolerated, showing no serious side effects, and suggests that BCC could be a beneficial addition to existing osteoarthritis therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the novel low molecular weight hydrolyzed chicken sternal cartilage extract, BioCell Collagen, on improving osteoarthritis-related symptoms: a randomized, double-blind, placebo-controlled trial. Schauss, AG., Stenehjem, J., Park, J., et al.[2022]

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]

Collagen-based medical products are safe and effective for delivering drugs and biologics, thanks to their biodegradable nature and minimal tissue reaction.

Regulatory requirements for collagen products are evolving, particularly concerning safety standards for animal-derived materials, which must address risks like Transmissible Spongiform Encephalopathies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Global regulatory registration requirements for collagen-based combination products: points to consider. O'Grady, JE., Bordon, DM.[2019]

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 90-day clinical trial with 120 participants showed that daily oral supplementation with a liquid nutraceutical containing hydrolyzed fish collagen and other active ingredients significantly improved skin elasticity by 40% and enhanced skin architecture, as confirmed by both histological analysis and self-reported perceptions.

The same supplementation also led to a 43% reduction in joint pain and a 39% improvement in joint mobility, suggesting that this combination may effectively support both skin health and joint function as part of the aging process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily oral supplementation with collagen peptides combined with vitamins and other bioactive compounds improves skin elasticity and has a beneficial effect on joint and general wellbeing. Czajka, A., Kania, EM., Genovese, L., et al.[2019]

References

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

Oral Collagen Supplementation: A Systematic Review of Dermatological Applications [2019]

2. 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]

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

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

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

Effect of the novel low molecular weight hydrolyzed chicken sternal cartilage extract, BioCell Collagen, on improving osteoarthritis-related symptoms: a randomized, double-blind, placebo-controlled trial. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Global regulatory registration requirements for collagen-based combination products: points to consider. [2019]

7. 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]

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

Daily oral supplementation with collagen peptides combined with vitamins and other bioactive compounds improves skin elasticity and has a beneficial effect on joint and general wellbeing. [2019]

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

Effects of Different Vitamin C-Enriched Collagen Derivatives on Collagen Synthesis. [2019]