Nutraceutical Supplements for Alopecia

Overseen By Emily Hu

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Nutraceutical Wellness Inc.

Must not be taking: Finasteride, Minoxidil, Anticoagulants, others

Disqualifiers: Pregnancy, Alopecia, Thyroid disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different hair supplements can help women experiencing hair thinning. It aims to determine if these supplements can address the underlying causes of hair thinning. Participants will try one of four different Nutrafol hair growth supplements, selected by the researchers. Women who notice thinning hair and have had this confirmed by a dermatologist may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on hair health.

Will I have to stop taking my current medications?

The trial requires participants to stop using any products or medications known to promote hair growth, like finasteride or minoxidil, at least 6 months before starting the study. If you are using hormones for birth control or hormone replacement therapy, you must have been on a stable dose for at least 6 months. Additionally, you cannot use any medications or medicated shampoos that might cause hair loss or affect hair growth.

Is there any evidence suggesting that these supplements are likely to be safe?

Research has shown that Nutrafol Women's Balance Hair Growth Supplement is safe and effective for menopausal women. In one study, all participants experienced improved hair growth after nine months, with no major side effects.

Nutrafol Women's Hair Growth Supplement has also been studied and found to safely aid women with thinning hair in growing more hair, again without major side effects.

Nutrafol Women's Postpartum Hair Growth Supplement is designed for new mothers and is safe to use while breastfeeding. Although specific safety details from studies aren't provided, it emphasizes safety for new mothers.

Nutrafol Women's Vegan Hair Growth Supplement underwent a six-month study with individuals on a plant-based diet. The study demonstrated significant hair growth and improved hair quality, with no major safety issues.

These findings suggest that Nutrafol supplements are generally safe for the groups studied. However, individual results may vary, so consulting a healthcare provider before starting any new supplement is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Nutrafol's hair growth supplements because they offer a natural, nutraceutical-based approach to treating alopecia. Unlike traditional treatments like minoxidil or finasteride, which often involve synthetic chemicals, Nutrafol uses botanical ingredients that support hair health from within. Each supplement targets specific life stages or needs, such as hormone balance, postpartum recovery, or vegan preferences, providing personalized options that are not typically found in conventional hair loss treatments. This approach not only focuses on hair growth but also on overall wellness, appealing to those seeking a holistic alternative.

What evidence suggests that these nutraceutical supplements could be effective for alopecia?

This trial will evaluate four different Nutrafol hair growth supplements. Research has shown that Nutrafol's supplements can improve hair health. Specifically, for the Women's Balance supplement, all menopausal women in the study experienced hair growth improvement after 9 months. The Women's Hair Growth supplement resulted in noticeable hair growth, with 93% of women reporting healthier hair after 6 months. The Postpartum supplement helped 91% of users experience less hair shedding after 2 months and visible improvements in their hairline after 4 months. In a 6-month study, Nutrafol's Vegan supplement also demonstrated significant hair growth. These studies highlight Nutrafol's potential to address thinning hair at different life stages. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for women experiencing hair loss, including conditions like Alopecia and Alopecia Areata. Participants should be interested in trying dietary supplements designed to promote hair growth.

Inclusion Criteria

Willing and able to adhere to the same dietary lifestyles for the duration of the study

General good health, as determined by the Investigator or qualified sub-investigator

Able to complete and understand the various questionnaires

Exclusion Criteria

I have a history of cancer other than skin cancer or am currently receiving cancer treatment.

Individuals who are pregnant, planning a pregnancy, nursing, or within 1-year post-partum

Individuals who have experienced serious complications due to COVID-19 previously or during the study as determined by the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nutraceutical hair growth supplements and are monitored at baseline, 90 days, and 180 days

26 weeks

6 visits (in-person), 2 compliance phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nutrafol Women's Balance Hair Growth Supplement
• Nutrafol Women's Hair Growth Supplement
• Nutrafol Women's Postpartum Hair Growth Supplement
• Nutrafol Women's Vegan Hair Growth Supplement

Trial Overview The study tests four Nutrafol supplements: Vegan, Balance, Postpartum, and a general Hair Growth supplement. It aims to see if these products can improve thinning hair by addressing its root causes.

How Is the Trial Designed?

Group I: Nutrafol Hair Growth Supplement Experimental Treatment 4 Interventions

4 commercially available hair growth nutraceuticals will be evaluated. Treatment groups will be assigned according to the investigator's discretion. Efficacy comparisons will not be made across treatment groups.

Nutrafol Women's Balance Hair Growth Supplement is already approved in United States for the following indications:

Approved in United States as Nutrafol Women's Balance for:

• Hair thinning in women before, during, and after menopause

Who Is Running the Clinical Trial?

Nutraceutical Wellness Inc.

Lead Sponsor

Trials

8

Recruited

1,000+

Published Research Related to This Trial

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]

In a study of 10 adults with androgenetic alopecia, 80% showed improvement after 24 weeks of taking the oral supplement Forti5®, which includes ingredients like green tea extract and omega fatty acids.

The supplement led to a significant increase in terminal hair count (5.9%) and Hair Mass Index (9.5%), suggesting it may be an effective adjunct treatment for hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open-Label Evaluator Blinded Study of the Efficacy and Safety of a New Nutritional Supplement in Androgenetic Alopecia: A Pilot Study. Nichols, AJ., Hughes, OB., Canazza, A., et al.[2020]

A 12-month study of a nutraceutical supplement showed significant improvements in hair growth and quality for women experiencing hair thinning, particularly beneficial for post-menopausal women.

Participants who initially received a placebo also experienced significant hair growth and reduced shedding after switching to the active supplement, indicating its long-term efficacy and potential positive effects on quality of life and menopausal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Long-Term Study of the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women. Ablon, G., Kogan, S., Raymond, I.[2022]

The study identified that the most commonly reported plant species associated with adverse reactions (ARs) were black cohosh, hops, and soybean, indicating potential safety concerns with these phytoestrogenic products.

Adverse reactions were frequently related to gastrointestinal, skin, and reproductive system disorders, and there was a notable association between phytoestrogenic products and postmenopausal bleeding, highlighting the need for further research on their safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Safety Concerns on Herbal Products with Assumed Phytoestrogenic Activity. Tjeerdsma, AM., van Hunsel, FPAM., van de Koppel, S., et al.[2023]

The use of dietary supplements containing phyto-oestrogens, such as hop and soy, may lead to postmenopausal bleeding due to endometrial proliferation, as illustrated by four patient reports to the Netherlands Pharmacovigilance Centre.

Despite being available over-the-counter and perceived as safe, these herbal supplements can cause adverse drug reactions, highlighting the need for awareness among healthcare providers regarding their potential effects during diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postmenopausal bleeding and dietary supplements: a possible causal relationship with hop- and soy-containing preparations]. van Hunsel, FP., Kampschöer, P.[2012]

In a 6-month study involving 70 perimenopausal, menopausal, and postmenopausal women, the nutraceutical supplement Nutrafol® Women’s Balance Capsules significantly increased hair counts and reduced hair shedding compared to a placebo, with notable improvements observed by day 90 and day 180.

The supplement was well-tolerated, indicating a favorable safety profile while effectively promoting hair growth and quality in women experiencing hair thinning due to menopause.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair. Ablon, G., Kogan, S.[2021]

In a study of 60 perimenopausal women, the use of nutraceuticals containing Equol, Resveratrol, Quercetin, and Passiflora significantly reduced menopause symptoms over 6 months, improving the modified Kupperman Index scores from 35 to 18.

The nutraceuticals also led to significant improvements in quality of life and sexual function by the second follow-up, with the Female Sexual Function Index score increasing from 23.1 to 27.6 and the Female Sexual Distress Scale score decreasing from 18.1 to 11.3, indicating enhanced sexual well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nutraceuticals on quality of life and sexual function of perimenopausal women. Caruso, S., Cianci, S., Cariola, M., et al.[2022]

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]

The EFSA Panel reconfirmed that EstroG-100™, a hot-water extract from three herbal roots, is safe for use in food supplements at a maximum intake of 175 mg/day for post-menopausal women, based on various toxicity studies.

Despite the applicant proposing a higher intake level of 514 mg/day, the Panel maintained its safety conclusion due to insufficient evidence on liver and haematological effects at higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statement on the safety of EstroG-100™ as a novel food pursuant to Regulation (EC) No 258/97. Turck, D., Bresson, JL., Burlingame, B., et al.[2023]

A study of 190 peri- and post-menopausal women in Bologna revealed that 79% used phytoestrogens primarily to alleviate hot flushes, with many reporting positive effects, especially long-term users who experienced greater relief from symptoms.

However, negative perceptions, such as edema, increased with long-term use, indicating that while phytoestrogens can be beneficial, monitoring for adverse effects is important for ongoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of phytoestrogens and effects perceived by postmenopausal women: result of a questionnaire-based survey. Girardi, A., Piccinni, C., Raschi, E., et al.[2022]

Citations

1. nutrafol.com nutrafol.com/women-balance/

Women's Balance The first and only hair growth supplement with published clinical studies on menopausal women. 100% of women showed improvement in hair growth after 9 months.

2. amazon.com amazon.com/Nutrafol-Supplements-Clinically-Dermatologist-Recommended/dp/B07QZ5CTTF

Nutrafol Women's Balance Hair Growth Supplements ... Nutrafol Women's Balance Hair Growth Supplements, Ages 45 and Up, Clinically Proven for Visibly Thicker Hair and Scalp Coverage, Dermatologist Recommended - 1 ...

3. nutrafol.com nutrafol.com/results/

Nutrafol Results - Before & After Hair Growth Progress In a 6-month clinical study, participants taking Nutrafol Women's Balance experienced significant hair growth. Before. Lilyana before taking Nutrafol ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29742189/

A Six-Month, Randomized, Double-Blind, Placebo ... A significant percentage of subjects receiving active treatment also reported improvement in hair growth, volume, thickness, and hair growth ...

5. mcgill.ca mcgill.ca/oss/article/medical-student-contributors-health-and-nutrition/nutrafol-holy-grail-hair-loss-or-overpriced-supplement

Nutrafol; A Holy Grail for Hair Loss or an Overpriced ... Another study showed a significant increase in baseline hair growth, coverage, density, and volume at weeks 12 and 24 for all 98 participants.

6. nutrafol.com nutrafol.com/

Nutrafol: Hair Wellness from Within Nutrafol Women's Balance is the only hair growth supplement with published clinical studies in menopausal women with hair thinning.†.

7. ulta.com ulta.com/p/womens-balance-45-clinically-proven-hair-growth-supplement-pimprod2053184?sku=2644735

NUTRAFOL - Women's Balance 45+ Clinically Proven Hair ... Nutrafol Women's Balance 45+ Clinically Proven Hair Growth Supplement is physician-formulated for before, during, and after menopause with ...