Rice Ceramide Supplementation and Skin Health
Condition: Skin Condition
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      Ceramides have been added to newer cosmetic products to improve skin barrier function and
      exogenously replenish skin ceramides. Of the stratum corneum intercellular lipids, Ceramides
      are the most effective at restoring barrier function and increasing skin hydration. Different
      ceramides have been incorporated into cosmetic formulations, but understanding the
      differences between ceramides used in formulations, or even identifying ceramides in
      formulations can be complex. This is mostly because of an archaic nomenclature system that is
      fundamentally flawed based on current scientific evidence. In the recent past, due to the
      unique bioactive components of rice, it has been explored to a certain limit for its
      components. Further, much attention has been paid to the plant ceramide with its
      incorporation into cosmetics and food preparations owing to its safety in contrast to
      animal/synthetic origin. There are reports on plant ceramide deciphering its protective
      effects on human skin by preventing moisture loss. It has been anticipated that ceramides,
      fatty acids, and cholesterol in combination with hydrocortisone (HC) can be an useful
      therapeutic agents against xerosis and atopic dermatitis.

      The beneficial effects of oral intake of plant-derived ceramides for skin hydration and skin
      barrier reinforcement have been established in several studies involving animal models as
      well as human subjects. Ingestion of konjac ceramides has also shown positive effects in
      atopic dermatitis patients as well as healthy volunteers. Results showed improved skin
      symptoms and reduced skin allergic responses. The foregoing studies support the beneficial
      effects of oral intake of plant ceramides and their potential complementary and alternative
      therapeutic applications in the restoration and maintenance of skin barrier function.
      However, the findings from human study are still very limited, more detailed and
      comprehensive studies are still required to document the clinical efficacy of oral
      supplementation of ceramides. Thus, this study aims to evaluate the effects of rice ceramides
      consumption in improving skin health.
    

Detailed description: 
      EFFECTS OF RICE CERAMIDES IN IMPROVING SKIN HEALTH - STUDY PROTOCOL

      INTRODUCTION

      Background

      Ceramides are important structural components of the epidermis, which plays a key role in
      maintaining homeostasis of the human body. Specifically, its outermost layer, known as the
      stratum corneum, forms a barrier between the external environment and the internal body. This
      barrier function serves multiple purposes including prevention of water loss and protection
      from foreign insult. The structure of the stratum corneum is often referred to as ''brick and
      mortar''. The ''bricks'' are terminally differentiated keratinocytes composed mostly of
      keratin filaments and filaggrin. The ''mortar'' is composed of intercellular lipids arranged
      into lamellar layers consisting of ceramides, free fatty acids, and cholesterol. Ceramides
      are the predominant lipid comprising approximately 50% of the intercellular lipid content by
      mass. Stratum corneum lipids are essential for maintaining skin barrier function and
      preventing transepidermal water loss (TEWL). Disruptions or damage to the stratum corneum can
      impair skin barrier function and result in TEWL.

      Ceramides have been added to newer cosmetic products to improve skin barrier function and
      exogenously replenish skin ceramides. Of the stratum corneum intercellular lipids, Ceramides
      are the most effective at restoring barrier function and increasing skin hydration. Different
      ceramides have been incorporated into cosmetic formulations, but understanding the
      differences between ceramides used in formulations, or even identifying ceramides in
      formulations can be complex. This is mostly because of an archaic nomenclature system that is
      fundamentally flawed based on current scientific evidence. In the recent past, due to the
      unique bioactive components of rice, it has been explored to a certain limit for its
      components. Further, much attention has been paid to the plant ceramide with its
      incorporation into cosmetics and food preparations owing to its safety in contrast to
      animal/synthetic origin. There are reports on plant ceramide deciphering its protective
      effects on human skin by preventing moisture loss. It has been anticipated that ceramides,
      fatty acids, and cholesterol in combination with hydrocortisone (HC) can be an useful
      therapeutic agents against xerosis and atopic dermatitis. In addition, report also showed
      that topical emulsions containing ceramides possessed anti-inflammatory and skin beneficial
      properties. Hence, isolation of ceramide from natural source possessing anti-inflammatory and
      skin protective properties becomes vital.

      The beneficial effects of oral intake of plant-derived ceramides for skin hydration and skin
      barrier reinforcement have been established in several studies involving animal models as
      well as human subjects. A randomized, double-blind placebo-controlled trial was conducted on
      women with dry skin to investigate the moisturizing effect of dietary supplement containing
      wheat extract enriched with ceramides and digalactosyldiglycerides (DGDG). According to the
      finding, there was a significant increase in skin hydration with improved associated clinical
      signs (itching, squamae, roughness, and redness). Ingestion of konjac ceramides has also
      shown positive effects in atopic dermatitis patients as well as healthy volunteers. Results
      showed improved skin symptoms and reduced skin allergic responses . The foregoing studies
      support the beneficial effects of oral intake of plant ceramides and their potential
      complementary and alternative therapeutic applications in the restoration and maintenance of
      skin barrier function. However, the findings from human study are still very limited, more
      detailed and comprehensive studies are still required to document the clinical efficacy of
      oral supplementation of ceramides. Thus, this study aims to evaluate the effects of rice
      ceramides consumption in improving skin health.

      Objective

      To determine the effects of rice ceramides consumption in improving skin health.

      METHODOLOGY

      Study Design

      This will be an open-label, single arm, prospective interventional study that involves
      three-months period of rice ceramides (komercera) supplementation. Fifty subjects will be
      recruited via convenient sampling for this study.

      Study Population

      Fifty subjects are required to consume rice ceramides (komecera) supplements at the dosage of
      40mg, one vegetarian capsule per day. Monthly follow-up for the duration of 3 months will be
      conducted to allow sufficient time for the changes to take place.

      Good general healthy subjects who are free from any skin diseases, aged 20 to 45 and willing
      to comply with rice ceramides consumption plan will be recruited. Participant with underlying
      skin medical condition such as eczema, psoriasis, rosacea, atopic dermatitis, ichthyosis or
      vitiligo, undergoing medication plan, currently taking antimicrobial or antiviral medication,
      undergone major surgical procedures in the past six months, pregnant or lactating woman will
      be excluded from this study. All the study participants will be provided with a participant
      information sheet, briefly containing the research detail and a written informed consent will
      also be sought from each recruited participant.

      Assessment will be conducted at baseline when they were first recruited, and also during
      their 3 times monthly follow ups. Participants will be remunerated with RM200 vouchers by the
      end of the study to compensate the time they spent in this research. Location of recruitment
      will be at public settings in Klang Valley.

      Clinical Assessment

      The efficacy of rice ceramides in improving the overall skin health will be assessed using
      the parameters below: -

        -  Total Wrinkle Score (TWS)

        -  Skin firmness and elasticity (Courage & Khazaka Cutometer®, MPA580)

        -  Skin hydration (Courage & Khazaka Corneometer®, CM825)

        -  Transepidermal Water Loss and Skin Barrier Function (Courage & Khazaka Tewameter®, TM
           300)

        -  Skin whitening (Courage & Khazaka Mexameter®, MX18)

        -  Sebum Secretion (Courage & Khazaka Sebumeter®, SM815)

        -  Skin pH (Courage & Khazaka pH meter®, PH900)

      The assessment mentioned above will be carried out using Multiprobe Adapter System (MPA),
      which is a non-invasive assessment.

      Subjects Self-Perceived Assessment

      Subject will also be required to do a self-perceived Visual Analogue Scale (VAS) to reflect
      their self-perceived changes.

      Statistical Analysis

      Demographic characteristics will be presented as categorical data, expressed in frequency and
      percentage. All outcomes will be analyzed as continuous dependent variables, presented as
      mean ± SD. The changes in clinical assessment from baseline visit to last follow-up visit
      will be analyzed using general linear model (GLM) for repeated measures model.
      Within-subjects factor will be defined as the sampling time point. Gender and age will be
      tested as between-subject effect. Homogeneity of the variance and covariance structure of the
      dependent variables will be assessed by Levene and Box M tests. Sphericity test of the
      residual covariance matrix will be assessed using Mauchly's sphericity test. Results will
      only be considered significant if P<0.05 with 95% of confidence interval. Statistical
      analysis will be performed using SPSS 26.0 (IBM Corp., New York, United States) for MacOS.
    

Intervention name(s): Rice ceramide supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): At the dosage of 40mg daily for 3 months
Intervention model: Single Group Assignment
Intervention model description: This will be a single arm and open-labelled prospective study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Rice ceramide; Supplementation; Skin health