Lee S-W, Sin H-S, Hurh J, Kim S-Y. Anti-wrinkle effect of BB-1000: A double-blind, randomized controlled study. Cosmetics. May 16, 2022;9(3):50. doi: 10.3390/cosmetics9030050.
The skin, the largest of human organs, forms a structural barrier between the internal and external environments of the body. Skin aging is caused by structural and functional changes in skin cells and tissues, indicated by moisture loss and wrinkling. As lifespans and incomes increase, interest is also rising in anti-aging products. Treatments with α-hydroxy acids, antioxidants, moisturizers, retinoids, sunscreens, botulinum toxin injection or filler, and/or chemical, physical, and laser dermabrasion are used but may have adverse effects (AEs) or become less effective over time. There is growing interest in functional foods for skin vitality.
Anthocyanins, flavonoids, and phenols in blackberry (BB; Rubus fructicosus, Rosaceae) fruits exert anti-cancer, antiallergic, anti-obesity, and antibacterial effects. Lactic acid bacteria (Lactiplantibacillus plantarum, Lactobacillaceae [LP]), with its antioxidant, antibacterial, and immunomodulating activities, are reported to reduce skin aging in vivo and in human models. The authors conducted a randomized, double-blinded, placebo-controlled clinical trial (RCT) of the effects of BB-1000 (supplier not explicitly disclosed but presumed to be Jeonju AgroBio-Materials Institute; Jeonju-si, Jeollabuk-do, Republic of Korea), a novel fermented dietary supplement combining BB and LP, on dry skin and wrinkles in Korean adults aged 35-60 years. Their previous in vivo studies of BB-1000 reported inhibition of ultraviolet light-induced wrinkling, increased skin thickness, and collagen fiber accumulation. RCT participants were screened on November 30, 2020; enrolled on December 14; and completed the study on April 28, 2021. Process of study recruitment was not outlined.
The study was conducted in accordance with functional cosmetic efficacy evaluation guidelines of the Korean Ministry of Food and Drug Safety. Test capsules (500 mg) were composed of 26.67% BB-1000 with synthetic grape (Vitis vinifera, Vitaceae) flavor, stevia (Stevia rebaudiana, Asteraceae), dextrose and dextrin (usually derived from corn [Zea mays, Poaceae] or wheat [Triticum aestivum, Poaceae]), fillers, and stabilizers. Placebo capsules had no BB-1000 but contained cellulose, citric acid anhydrous (from Citrus spp., Rutaceae), additional sugars, and synthetic pigments.
At the initial screening (visit 1), participants were photographed (front of face; left and right sides) to compare wrinkle characteristics in the corners of the eye (“crow’s feet”). Eligible participants had wrinkles rated fine/mild (grade 3) < very severe (grade 10) at both eyes. Wrinkle parameters recorded included average roughness (Ra), maximum peak-to-valley (Rmax), maximum peak height (Rp), maximum valley depth (Rv), and maximum average roughness (Rz). The Corneometer® CM 825 (Courage & Khazaka; Cologne, Germany), a device to measure skin moisture 30-40 μm below the stratum corneum without interference from cosmetics or dermatological drugs, was applied, with the average value of > three measurements at the orthogonal intersection of the corner of the eye and tip of the nose used. Demographic, lifestyle, and cosmetic use data; medical history; vital signs; drug use; and pregnancy response were collected.*
At randomization (visit 2; day [D] 0), 100 consenting, eligible participants were randomized to either the BB-1000 or placebo group and received a 12-week supply of their blinded supplement. The dosage of BB-1000 or placebo is stated to have been both 800 mg/kg/day or 500 mg/day so there appears to be a reporting error, and the actual study dosage is unclear. Participant weight is not mentioned among data collected. At visits 1, 3 (D0 + 42 ± 7), and 4 (D0 + 84 ± 5), participants washed away facial skin waste or debris and rested for 30 minutes at a consistent room temperature and humidity before wrinkle and skin moisture measures were taken. During the RCT, 13 from each group dropped out (T = 26), leaving 74 completers. Safety of BB-1000 was monitored via reported AEs and blood, urine, and biochemical analyses at visits 1 and 4.
In statistical analysis, P < 0.05, < 0.01, and < 0.001 were considered significant. There were no significant differences between groups in wrinkle parameters or skin moisture at visit 1. At visit 3, neither wrinkle grade nor volume was reduced in either group, but at visit 4 these parameters were significantly reduced from visit 1 in the BB-1000 group (P < 0.05 for both measures). At visit 4, significant improvements were also seen for BB-1000 vs. placebo in Ra (P < 0.001), Rmax (P < 0.01), and in Rp and Rz (P < 0.05 for both). Skin moisture increased in both groups at six and 12 weeks, without statistically significant differences between groups at either point. There were no significant changes in any safety parameter at 12 weeks. No AEs are mentioned.
The effects of BB-1000 are posited to be primarily due to its antioxidant activity, but studies of its specific mechanisms are needed. A comparison of BB-1000 with unfermented BB extract and LP alone would be desirable to investigate their relative contribution to anti-wrinkle effects. Used with a moisturizer these effects may be enhanced. It was reported that anti-wrinkle effects of candelabra aloe (Aloe aborescens, Asphodelaceae) are also boosted by fermentation. The authors state no conflict of interest.
*Analyses of participants’ lifestyle factors and concomitant drug use are presented in Supplementary Materials. Other data collected is not mentioned in results.