Nutritional Supplement for Connective Tissue Health

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: Pregnancy, Smoking, others

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a natural supplement (Natural Product Supplement) can boost collagen production when combined with collagen protein. Collagen is a key component of connective tissues, and the study aims to determine if certain vitamins and compounds can enhance its benefits. Participants will take either the natural supplement or a placebo to compare effects. The trial seeks healthy adults aged 18 to 30 who are not on medications that could affect the results. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on natural supplements and their potential health benefits.

Do I need to stop taking my current medications?

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

Will I have to stop taking my current medications?

The trial requires that you not be on any medication that might interfere with the study outcomes, so you may need to stop taking certain medications.

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

Research has shown that collagen supplements are usually safe for consumption. Studies suggest that collagen peptides benefit bone and joint health. One study found that combining collagen supplements with exercise might alleviate bone and joint issues.

Regarding safety, strong evidence of major side effects from collagen itself is lacking. As a protein already abundant in the body, collagen poses minimal risk. The supplement in this trial also includes vitamin C, vitamin E, epicatechin, and stevia extract. Vitamins C and E are common in many diets and are generally safe at the doses used here. Epicatechin, found in foods like chocolate and tea, is considered safe in moderate amounts. Stevia, a natural sweetener, is widely used and generally safe for most people.

Overall, the ingredients in this natural supplement are well-known and usually safe. However, as with any supplement, personal allergies or sensitivities should be considered. Always consult a healthcare provider if concerns arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike most treatments for connective tissue health, which often focus on pharmaceutical interventions or basic supplements, this new approach uses a unique combination of natural ingredients. The treatment leverages hydrolyzed collagen, known for supporting skin, joint, and bone health, but enhances its effects with vitamin C, epicatechin, vitamin E, and stevia extract. This combination is designed not only to support connective tissue but also to boost antioxidant levels and potentially improve overall wellness. Researchers are excited because these ingredients, particularly epicatechin from cocoa, have shown promise in supporting tissue structure and function, offering a more holistic approach to connective tissue health.

What evidence suggests that this trial's treatments could be effective for connective tissue health?

This trial will compare a Natural Product Supplement with a Placebo for connective tissue health. Research has shown that collagen supplements can improve joint function and reduce joint pain, benefiting those with connective tissue issues. Studies have found that hydrolyzed collagen can enhance skin elasticity and hydration, potentially benefiting joints as well. When combined with vitamin C, collagen can further boost the body's collagen production. Recent studies suggest that this supplement holds promise for improving connective tissue health. ^{1 4 6 7 8}

Who Is on the Research Team?

Keith Baar, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Pregnancy

Smoking

I am not on medications 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

Treatment

Participants consume a dose of hydrolyzed collagen supplemented with vitamin C, epicatechin, vitamin E, and stevia extract or placebo for 7 days

7 days

Follow-up

Participants are monitored for collagen protein synthesis and ligament strength post-exercise

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Natural Product Supplement
• Placebo control

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.

How Is the Trial Designed?

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+

AmpHP, Inc

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

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]

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]

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]

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]

In a study involving 10 recreationally active males, both vitamin C-enriched gelatin and hydrolyzed collagen supplementation led to a 20% increase in N-terminal peptide of procollagen levels after exercise, suggesting potential benefits for collagen synthesis.

All collagen supplements similarly increased circulating amino acids, but the variability in results means that further research is needed to confirm the effectiveness of these nutritional strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Different Vitamin C-Enriched Collagen Derivatives on Collagen Synthesis. Lis, DM., Baar, K.[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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8824545/

Collagen Supplements for Aging and Wrinkles: A Paradigm ... The overarching goal of this research is to collate the consequences of oral collagen with those of topical collagen in reducing or delaying the aging process.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8521576/

The effects of collagen peptide supplementation on body ... The results indicated that COL is most beneficial in improving joint functionality and reducing joint pain. Certain improvements in body composition, strength ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023021680

Collagen supplementation in skin and orthopedic diseases Hydrolyzed collagen supplementation promotes skin changes, such as decreased wrinkle formation; increased skin elasticity; increased hydration.

4. withpower.com withpower.com/trial/phase-dietary-supplementation-10-2023-017e4

Nutritional Supplement 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03293004

Collagen Vitamin C Dose Response Performance These data conclusively demonstrate that gelatin supplementation can increase exercise-induced collagen synthesis in humans. Hydrolyzed collagen has a similar ...

6. healthline.com healthline.com/nutrition/collagen

Collagen: Benefits, Side Effects, and Caution Collagen is the most abundant protein in your body. It has several health benefits and uses, and taking it may benefit some people.

7. nutritionsource.hsph.harvard.edu nutritionsource.hsph.harvard.edu/collagen/

Collagen - The Nutrition Source - Harvard University Collagen is the most abundant protein in the body. Its fiber-like structure is used to make connective tissue. Like the name implies, this type of tissue.

8. my.clevelandclinic.org my.clevelandclinic.org/health/articles/23089-collagen

Collagen: What It Is, Types, Function & Benefits Collagen accounts for 30% of your body's protein. It provides structure, support or strength to your skin, muscles, bones and connective tissues.