A randomized double-blind placebo-controlled clinical trial to evaluate the effect of an Annurca apple supplement formula in androgenic alopecia

Publication Date:
2023-05-24

Institutions involved:

Osun Solutions S.r.l., Italy
EVRA S.r.l. Società Benefit, Italy

Participants:
Total Subjects: 80 individuals with androgenic alopecia - Groups: 40 received AT HAIR-FUL AA® supplement; 40 received placebo Gender: Mixed (men and women)

Duration:
Treatment Period: 180 days

Dosage:
2 capsules per day of whole Annurca apple extract (peel and pulp)

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Key Takeaways:

This is the second randomized, placebo-controlled clinical trial showing decreased hair loss and improved hair growth in pattern baldness patients using oral apple polyphenol extracts.

Subjects taking this apple polyphenol supplement showed a statistically significant increase in hair density and weight after 180 days of treatment.

From the authors: “Hair density and weight significantly increased and hair loss significantly decreased over time (p<0.001).”

Apple Poly Summary:

Why Is This Study Important? This trial provides rare, high-quality clinical evidence that an apple-derived supplement can significantly improve hair density and reduce hair loss in individuals with androgenic alopecia. It supports the therapeutic potential of polyphenol-rich nutraceuticals and offers a well-tolerated alternative to conventional treatments.

You Should Know: The apple polyphenol supplement studied here contained very moderate amounts of the active ingredients identified to improve hair growth in pattern baldness. This is the second clinical trial showing hair growth improvement using an apple-derived dietary supplement. Apple Poly® products contain far higher amounts of these active ingredients.

In Plain English: Researchers tested an apple-based supplement on people with hair loss. After six months, those who took the supplement had thicker hair and less shedding compared to those who didn’t. The supplement was safe and easy to use.

For Medical Professionals: This randomized, double-blind, placebo-controlled trial demonstrated that AT HAIR-FUL AA®, a polyphenol-rich Annurca apple extract, significantly increased hair density and weight while reducing hair loss (p < 0.001) over 180 days. The formulation was well tolerated, with no significant gastrointestinal side effects, supporting its use as a nutraceutical intervention for androgenic alopecia.

Abstract:

Androgenic alopecia is the most common form of hair loss, affecting men and women at different ages. The role of natural bioactive compounds has gained increasing recognition as a potential means to address hair loss. There is great interest in oligomeric procyanidins, particularly procyanidin B2, which have been shown to possess hair-growing activity. Annurca (Malus pumila Miller cv Annurca) apple fruits have one of the highest amounts of oligomeric procyanidins, specifically of procyanidin B2, compared to more common apple cultivars. In this study, randomized double-blind controlled parallel group trial was performed to compare the efficacy of the Annurca apple fruit extract as nutraceutical AT HAIR-FUL AA® food supplement with a placebo in hair growth. AT HAIR-FUL AA® procyanidin B2 whole fruit (peel and pulp) is characterized by a complex mixture of polyphenolic compounds, especially chlorogenic acid (400 - 600 μg/g) and procyanidin B2 (60-100 μg/g). The products were assigned to 80 enrolled subjects with alopecia, divided into 2 groups: 40 subjects took AT HAIR-FUL AA® food supplement and 40 subjects took the alternative treatment (PLACEBO). Each group of volunteers underwent 180 days of treatment, with the intake of 2 capsules per day. After that, volunteers took nothing for 30 consecutive days (follow up). The AT HAIR-FUL AA® food supplement significantly affected hair loss: hair density and weight significantly increased and hair loss significantly decreased over time (p<0.001). Moreover, we observed a fairly good pleasantness and a good skin and gastro-intestinal tolerability of the product, confirming its compliance of use: the product did not have a significant effect on gastrointestinal disorder and stomach ache onset (p=0.41 and p=0.25, respectively). AT HAIR-FUL AA® food supplement could be used as potential agent to induce hair growth.

De Biasio, Filomena, et al. “A Randomized Double-Blind Placebo-Controlled Clinical Trial to Evaluate the Effect of an Annurca Apple Supplement Formula in Androgenic Alopecia.” Journal of Applied Cosmetology, vol. 41, no. 2, 2023, pp. 28–46. https://doi.org/10.56609/jac.v41i2.276.