Rice Ceramide Supplementation and Skin Health

NCT05101421 | Completed

• 1 other identifier: NW-RC-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Skin Condition

Keywords

Rice ceramide; Supplementation; Skin health

Outcome Measures

Primary Outcomes (7)

• Wrinkle change

  To be assessed using Total Wrinkle Score (TWS). TWS has a minimum value of 4 and maximum value of 20, with higher values indicating higher severity.

  Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

• Change in skin firmness and elasticity

  To be assessed using Courage \& Khazaka Cutometer®, MPA580

  Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

• Change in skin hydration

  To be assessed using Courage \& Khazaka Corneometer®, CM825

  Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

• Change in transepidermal water loss and skin barrier function

  To be assessed using Tewameter® TM 300

  Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

• Change in skin whitening

  To be assessed using Courage \& Khazaka Mexameter®, MX18

  Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

• Change in sebum secretion

  To be assessed using Courage \& Khazaka Sebumeter®, SM815

  Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

• Change in skin pH

  To be assessed using Courage \& Khazaka pH meter®, PH900

  Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

Secondary Outcomes (1)

• Adverse events

  Follow-up visit month 3

Study Arms (1)

Treatment arm

EXPERIMENTAL

To receive rice ceramide supplementation for 3 months

Dietary Supplement: Rice ceramide supplementation

Interventions

Rice ceramide supplementation DIETARY_SUPPLEMENT

At the dosage of 40mg daily for 3 months

Treatment arm

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health
• Free from any skin diseases
• Willing to comply with rice ceramide consumption plan
• Willing to give consent

You may not qualify if:

• Undergoing medication plan for skin condition
• Undergone major surgical procedures in the past six months
• Pregnant or lactating woman

Sponsors & Collaborators

• Nexus Wise Sdn Bhd: lead
• JScience Consultancy PLT: collaborator

Study Sites (2)

UCSI University

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Nexus Wise Sdn. Bhd.

Petaling Jaya, Selangor, 47400, Malaysia

Location

Related Publications (9)

• Henderson AJ, Ollila CA, Kumar A, Borresen EC, Raina K, Agarwal R, Ryan EP. Chemopreventive properties of dietary rice bran: current status and future prospects. Adv Nutr. 2012 Sep 1;3(5):643-53. doi: 10.3945/an.112.002303.

  PMID: 22983843 BACKGROUND

• Heule F. An oral approach to the treatment of photodamaged skin: a pilot study. J Int Med Res. 1992 Jun;20(3):273-8. doi: 10.1177/030006059202000309.

  PMID: 1397672 BACKGROUND

• Kawano K, Umemura K. Oral intake of beet extract provides protection against skin barrier impairment in hairless mice. Phytother Res. 2013 May;27(5):775-83. doi: 10.1002/ptr.4792. Epub 2012 Sep 4.

  PMID: 22949397 BACKGROUND

• Yeom M, Kim SH, Lee B, Han JJ, Chung GH, Choi HD, Lee H, Hahm DH. Oral administration of glucosylceramide ameliorates inflammatory dry-skin condition in chronic oxazolone-induced irritant contact dermatitis in the mouse ear. J Dermatol Sci. 2012 Aug;67(2):101-10. doi: 10.1016/j.jdermsci.2012.05.009. Epub 2012 Jun 7.

  PMID: 22726258 BACKGROUND

• Asai S, Miyachi H. [Evaluation of skin-moisturizing effects of oral or percutaneous use of plant ceramides]. Rinsho Byori. 2007 Mar;55(3):209-15. Japanese.

  PMID: 17441463 RESULT

• Guillou S, Ghabri S, Jannot C, Gaillard E, Lamour I, Boisnic S. The moisturizing effect of a wheat extract food supplement on women's skin: a randomized, double-blind placebo-controlled trial. Int J Cosmet Sci. 2011 Apr;33(2):138-43. doi: 10.1111/j.1468-2494.2010.00600.x.

  PMID: 20646083 RESULT

• Imokawa G, Akasaki S, Hattori M, Yoshizuka N. Selective recovery of deranged water-holding properties by stratum corneum lipids. J Invest Dermatol. 1986 Dec;87(6):758-61. doi: 10.1111/1523-1747.ep12456950.

  PMID: 3782858 RESULT

• Kimata H. Improvement of atopic dermatitis and reduction of skin allergic responses by oral intake of konjac ceramide. Pediatr Dermatol. 2006 Jul-Aug;23(4):386-9. doi: 10.1111/j.1525-1470.2006.00268.x.

  PMID: 16918640 RESULT

• Miyanishi K, Shiono N, Shirai H, Dombo M, Kimata H. Reduction of transepidermal water loss by oral intake of glucosylceramides in patients with atopic eczema. Allergy. 2005 Nov;60(11):1454-5. doi: 10.1111/j.1398-9995.2005.00915.x. No abstract available.

  PMID: 16197483 RESULT

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Chung Keat Tan, PhD

  UCSI University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: This will be a single arm and open-labelled prospective study

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: November 1, 2021
• Study Start: September 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: March 31, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anticipated to be available by the end of April 2022, for 6 months
• Access Criteria: Requestor need to send in an official email to sponsor to request for the data access.

Locations

MY (2)