Safety Evaluation of the Excessive Intake of Ceramide-Containing Acetic Acid Bacteria - A Randomized, Double-Blind, Placebo-Controlled Study Over a 4-week Period

Abstract

decrease in the stratum corneum of aged skin 2 .Supplementing ceramide to the skin contributes in maintaining or improving the skin barrier function. It has been reported that the application of ceramide-containing cream improved the destruction of the skin barrier, induced by tape stripping or sodium lauryl sulfate treatment 4 . Oral intake of plant-derived ceramides has also been reported to reduce transepidermal water loss TEWL in mice 5,6 , in healthy adults 6 , and even in patients with atopic dermatitis 7 .Ceramides are known to exist mainly in plants and animals, but they have also been found in a very limited number of species of Gram-negative bacteria 8,9 . Acetic acid bacteria is a general term for Gram-negative aerobic bacteria that oxidize and ferment ethanol to produce acetic acid. These bacteria are also used in the production of Abstract: Ceramide plays an important role in maintaining the skin barrier function. Aging and atopic dermatitis are known to reduce the levels of ceramide. Application of exogenous ceramide to the skin can restore the barrier function. In recent years, the effect of oral intake of ceramide has been demonstrated to improve the skin barrier function, and it has been marketed as a food supplement. Therefore, it is important to provide information on the safety of unintentional overdose of ceramide. This randomized, double-blind, placebo-controlled study was conducted in 30 healthy adults, aged between 20 and 60 years of age (both female and male). The subjects consumed either dietary supplement, comprising 1197 mg of acetic acid bacteria containing 9.06 mg of ceramide, or placebo for four consecutive weeks. Safety was evaluated based on physical measurements, blood test, urinalysis, adverse events, and side effects. The results showed several significant differences in physical measures and blood tests between the two groups. However, these differences were considered to be unrelated to the intake of the ceramide-containing acetic acid bacteria or placebo. Thus, no adverse effects or clinically concerning changes in physical, blood, and urine parameters were observed due to the excessive intake of the ceramide-containing acetic acid bacteria in the present study. TRIAL REGISTRATION: UMIN000035481

Effectiveness of Dietary Supplement for Skin Moisturizing in Healthy Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…Orally administered plant glucosylceramides (GlcCERs) derived from rice and konjac can elevate epidermis CERs by mechanisms including direct localization and usage of absorbed diet CERs in the epidermis without any metabolism conversion, the usage of exogenetic GlcCERs metabolins by keratinocytes to establish their own sphingolipids or the generation of skin CERs by metabolins ( 98 ). Other proposed mechanisms regarding skin barrier improvement include the stimulation of collagen synthesis ( 40 ), the inhibition of matrix proteases ( 40 ), and the elevation of the expression of aquaporin-3 ( 46 ). The improvement in skin moisture content resulting from the oral intake of ceramides is likely to be induced by the combination of the mechanisms described above.…”

Research Progress on Skin Aging and Active Ingredients

“…A group of 30 healthy adults (including women and men) aged 20 to 60 years old were selected and they consumed dietary supplements (including 1197 mg of acetic acid bacteria containing 9.06 mg of ceramide) for four consecutive weeks. Physical measurements, blood tests, and urine analyses showed that ceramide can preserve the skin barrier [ 43 ]. This reveals that ceramide has a role in protecting the skin and resisting the influence of external substances on skin aging.…”

Gastrointestinal Microbiome and Neurologic Injury

“…The impact of orally administered SCFAs on neurologic injury outcomes is still being investigated and has not been adequately tested on human neurologic injury patients in a clinical setting. However, SCFAs appear to have a relatively safe profile and can be administered easily through oral intake [ 118 ]. Thus, although more research is needed to evaluate efficacy in human subjects in this context, oral SCFAs may eventually serve as a safe and easy-to-use adjunct to post-neurologic injury therapy to improve patient outcomes.…”