Dietary Supplement for Hair Loss

Recruiting at 2 trial locations

Overseen By Emily Hu

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Nutraceutical Wellness Inc.

Must not be taking: Steroids, Immunosuppressants, Antidepressants, others

Disqualifiers: Hair loss disorders, Skin infections, others

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

174 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a dietary supplement to determine its safety and effectiveness for men experiencing hair thinning. Participants will receive either the supplement or a placebo (inactive substance) over nine months. The trial aims to assess whether the supplement helps with hair thinning. It suits men who notice thinning hair, particularly on the top or at the temples, and are willing to maintain their current hair routine and products during the study. As an unphased trial, this study provides a unique opportunity for participants to contribute to early-stage research and potentially benefit from an innovative approach to addressing hair thinning.

Will I have to stop taking my current medications?

The trial requires participants to avoid using any prescription or over-the-counter products that claim to impact hair loss or growth during the study. If you are on hormone replacement therapy, you must maintain a stable dose. Other medications may need to be reviewed for eligibility.

Is there any evidence suggesting that this dietary supplement is likely to be safe?

Research shows that the safety of dietary supplements for hair loss remains uncertain. Some studies suggest that certain hair supplements, such as Nutrafol and biotin, might pose health risks. However, the available information on these supplements is not robust, and their effectiveness varies from promising to ineffective. Specific safety information for the supplement tested in this trial is not available. While some people use these supplements without issues, their safety is not fully understood. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike standard hair loss treatments that often involve medications like minoxidil or finasteride, this dietary supplement offers a unique approach by addressing potential nutritional deficiencies that could contribute to hair thinning. Researchers are excited about this supplement because it could provide a natural alternative with fewer side effects, targeting hair health from within. Additionally, the simplicity of taking a dietary supplement may increase adherence compared to topical or prescription treatments.

What evidence suggests that this dietary supplement might be an effective treatment for hair thinning?

Research has shown that certain dietary supplements can aid hair growth. In one study, participants who took a nutritional supplement experienced noticeable hair growth after 3 and 6 months. Another study found that these supplements increased hair thickness after 24 weeks compared to a placebo. Additionally, a clinical trial reported a 10.1% increase in hair density, along with stronger and better-looking hair. This trial will evaluate a specific dietary supplement, provided to participants in the active treatment arm, to determine its effectiveness for those experiencing hair thinning. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for aging males who notice their hair thinning. Participants should be experiencing hair loss conditions like Alopecia Areata but not have hairy birthmarks or other forms of Alopecia.

Inclusion Criteria

I consider myself to be in good health.

Willing to sign a photography release

Willing to provide written informed consent and able to read, speak, write, and understand English

Exclusion Criteria

I am experiencing hair loss due to a specific cause.

Having a pregnant partner or a partner planning to become pregnant during the study

Having specific hairstyles or hair lengths

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the dietary supplement or placebo for 9 months

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Supplement

Trial Overview The study tests a dietary supplement against a placebo over 9 months to see if it's safe and effective in treating men's hair thinning.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Dietary Supplement

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Nutraceutical Wellness Inc.

Lead Sponsor

Trials

8

Recruited

1,000+

Published Research Related to This Trial

Viviscal®, a nutraceutical supplement containing proteins, lipids, and glycosaminoglycans from marine sources, has been shown in clinical studies to effectively stimulate hair growth and reduce hair shedding.

The supplement is considered safe and is part of a multi-therapy approach to treat alopecia and thinning hair, which is particularly challenging to diagnose and manage in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of a Sustainable Marine Extract for the Treatment of Thinning Hair: A Summary of New Clinical Research and Results from a Panel Discussion on the Problem of Thinning Hair and Current Treatments. Hornfeldt, CS., Holland, M., Bucay, VW., et al.[2015]

In a randomized, placebo-controlled study involving 15 healthy women over 180 days, an oral supplement significantly increased the number of terminal hairs in participants, with counts rising from 271 to 609.6 hairs compared to no change in the placebo group.

Participants taking the supplement reported noticeable improvements in hair volume, scalp coverage, and hair thickness, with no adverse events, indicating both safety and efficacy of the treatment for temporary hair thinning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Double-blind, Placebo-controlled Study Evaluating the Efficacy of an Oral Supplement in Women with Self-perceived Thinning Hair. Glynis, A.[2021]

A 6-month study involving 40 adult women showed that the nutraceutical supplement Nutrafol® significantly increased hair growth and quality, with improvements observed at both 90 and 180 days compared to a placebo.

The supplement was found to be safe, with no reported adverse events, and it effectively addressed hair loss by targeting inflammation, stress, and oxidative damage through its unique blend of active botanicals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair. Ablon, G., Kogan, S.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3509882/

A Double-blind, Placebo-controlled Study Evaluating the ... CONCLUSION. The daily administration of a proprietary nutritional supplement significantly increased hair growth after 90 and 180 days. Self-perceived ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06174441

The Effect of 24-week Dietary Intake of Food Supplements ... Significant change of hair thickness from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36449274/

Evaluation of the Safety and Effectiveness of Nutritional ... The review suggests a potential role for nutritional supplements in hair loss treatment, with some showing potential benefit, and rare, mild ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.16778

A Randomized, Double‐Blind, Placebo‐Controlled Study ... The results of this study show statistically significant improvements in subjects taking the supplement compared to placebo in hair growth and ...

5. jcadonline.com jcadonline.com/a-randomized-placebo-controlled-clinical-study-evaluating-a-dietary-supplement-for-hair-growth/

A Randomized, Placebo-controlled Clinical Study ... The study showed a significant increase in hair density (10.1%) and positive self-assessed improvements in hair strength, shedding, and appearance with the ...

6. jaad.org jaad.org/article/S0190-9622(20)30864-1/pdf

Unknown safety profile of ingredients in hair supplements Quality data, including randomized control trials examining dietary supplementation for hair growth in well-nourished adults, are limited, and significant.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07111299

Clinical Evaluation of a Nutraceutical Supplement for Hair ... This 6-month, double-blind, placebo-controlled, 1:1 randomized clinical trial investigates whether daily supplementation with Olistic Next Women ...

8. thedermdigest.com thedermdigest.com/hair-loss-supplements-buyer-beware/

Hair-loss supplements: buyer beware The evidence for the effectiveness of specific ingredients ranges from promising to nonexistent, according to a recent review.

9. womenshealthmag.com womenshealthmag.com/beauty/a65130958/are-hair-loss-supplements-safe/

Hair Loss Supplements & Treatments: Health Risks & What ... Popular hair loss supplements like Nutrafol and biotin and prescriptions like finasteride have come under fire for potential health risks.