The Efficacy of Amway Herbal Drink to Improve Skin Anti-aging

NCT05986799 | Unknown

• 1 other identifier: 23-RD-05-AY-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This goal of this two arms, randomized, double-blind controlled trial is to study whether Amway herbal drink could improve skin anti-aging in the middle-aged people of 30-60 years old. The main questions it aims to answer are:

1. 1.whether skin elasticity will be improved measured by Cutometer
2. 2.whether skin wrinkles/roughness/pores will be improved measured by Antera 3D

Conditions

Skin Laxity; Skin Lines

Keywords

Anti-aging; Amway herbal drink

Outcome Measures

Primary Outcomes (1)

• Change of Skin Elasticity

  The changes of skin elasticity from baseline to day 90 by CK Cutometer MPA580

  baseline day 0, day 90

Secondary Outcomes (1)

• Change of Facial Lines/Wrinkles

  baseline day 0, day 45, day 90

Study Arms (2)

Amway Herbal Drink

ACTIVE COMPARATOR

Amway Herbal Drink: 5g/sachet, containing the following active ingredients: * Extract of Phyllanthus emblica * Sophora flower extract * Wild cherry extract * Flower extract of Dendrobium candidum * Pomegranate extract * Resistant dextrin * γ-cyclodextrin

Dietary Supplement: Amway Herbal Drink

Placebo Drink

PLACEBO COMPARATOR

Placebo Drink: 5g/sachet, containing the following active ingredients: * Maltodextrin * Sugar * Honey

Dietary Supplement: Placebo Drink

Interventions

Amway Herbal Drink DIETARY_SUPPLEMENT

1 sachet per time, 3 times daily, for 3 months period.

Amway Herbal Drink

Placebo Drink DIETARY_SUPPLEMENT

1 sachet per time, 3 times daily, for 3 months period.

Placebo Drink

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects, aged 30 to 60 years, with a gender ratio of 3:7;
• Subjects are healthy;
• Visual assessment, smoothness is greater than or equal to 3 points (according to the Test Method of Efficacy Measurement of Nourishing Cosmetic Products issued by Chinese Association of Fragrance Flavor and Cosmetic Industries, the smaller the index, the better. Please refer to appendix II);
• Visual assessment, the gloss index is greater than or equal to 4 points (according to the Unilever Radiance Scale, the smaller the index is the better. Please refer to appendix III);
• Subjects could not use facial whitening and moisturizing products during the trial;
• Agree not to take other oral products with similar efficacy (such as collagen, sodium hyaluronate, etc.) during the trial. During the trial, participants agreed not to take any drugs or supplements. Do not do any medical beauty projects during the trial, do not participate in other interventional clinical research;
• Have a full understanding of the purpose, benefits, and possible risks and side effects of the study;
• Willing to comply with all research requirements and procedures;
• Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.

You may not qualify if:

• Use of any medications or supplements that may alter skin properties during the first 3 months of enrollment;
• Skin disease patients;
• Ggastrointestinal symptoms being treated;
• Lactose intolerance, allergy to fish and its products;
• Present with other organic diseases that affect intestinal function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, congenital megacolon, scleroderma, anorexia nervosa, etc.;
• Controlling diet, exercising more, or taking medications to control weight or affect appetite in the last 3 months;
• Subjects have any of the following medical history or clinical findings that may affect the evaluation of the trial effect: significant gastrointestinal disorders, liver, kidney, endocrine, hematological, respiratory and cardiovascular diseases;
• Abuse of alcohol or other illicit drugs, supplements currently or in the past, or OTC prescription drugs that may cause intestinal dysfunction or interfere with the evaluation of trial effects;
• Frequent use of drugs that may affect gastrointestinal function or the immune system, as judged by the researcher;
• Use of laxatives or other digestive substances in the 2 weeks prior to trial commencement;
• Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial;
• PI considers that volunteers cannot fully cooperate with the trial arrangement.

Sponsors & Collaborators

• Amway (China) R&D Center: lead

Study Sites (1)

Ai You Mei Medical Beauty Clinic

Jinhua, Zhejiang, China

RECRUITING

Related Publications (11)

• Cao C, Xiao Z, Wu Y, Ge C. Diet and Skin Aging-From the Perspective of Food Nutrition. Nutrients. 2020 Mar 24;12(3):870. doi: 10.3390/nu12030870.

  PMID: 32213934 BACKGROUND

• Blanpain C, Fuchs E. Epidermal stem cells of the skin. Annu Rev Cell Dev Biol. 2006;22:339-73. doi: 10.1146/annurev.cellbio.22.010305.104357.

  PMID: 16824012 BACKGROUND

• Zhang S, Duan E. Fighting against Skin Aging: The Way from Bench to Bedside. Cell Transplant. 2018 May;27(5):729-738. doi: 10.1177/0963689717725755. Epub 2018 Apr 25.

  PMID: 29692196 BACKGROUND

• Blume-Peytavi U, Kottner J, Sterry W, Hodin MW, Griffiths TW, Watson RE, Hay RJ, Griffiths CE. Age-Associated Skin Conditions and Diseases: Current Perspectives and Future Options. Gerontologist. 2016 Apr;56 Suppl 2:S230-42. doi: 10.1093/geront/gnw003.

  PMID: 26994263 BACKGROUND

• Michalak M. Plant-Derived Antioxidants: Significance in Skin Health and the Ageing Process. Int J Mol Sci. 2022 Jan 6;23(2):585. doi: 10.3390/ijms23020585.

  PMID: 35054770 BACKGROUND

• Fam VW, Charoenwoodhipong P, Sivamani RK, Holt RR, Keen CL, Hackman RM. Plant-Based Foods for Skin Health: A Narrative Review. J Acad Nutr Diet. 2022 Mar;122(3):614-629. doi: 10.1016/j.jand.2021.10.024. Epub 2021 Oct 30.

  PMID: 34728412 BACKGROUND

• Chaikul P, Kanlayavattanakul M, Somkumnerd J, Lourith N. Phyllanthus emblica L. (amla) branch: A safe and effective ingredient against skin aging. J Tradit Complement Med. 2021 Feb 9;11(5):390-399. doi: 10.1016/j.jtcme.2021.02.004. eCollection 2021 Sep.

  PMID: 34522633 BACKGROUND

• Binic I, Lazarevic V, Ljubenovic M, Mojsa J, Sokolovic D. Skin ageing: natural weapons and strategies. Evid Based Complement Alternat Med. 2013;2013:827248. doi: 10.1155/2013/827248. Epub 2013 Jan 29.

  PMID: 23431351 BACKGROUND

• Lee HR, Ryu HG, Lee Y, Park JA, Kim S, Lee CE, Jung S, Lee KH. Effect of Aronia Extract on Collagen Synthesis in Human Skin Cell and Dermal Equivalent. Oxid Med Cell Longev. 2022 Aug 8;2022:4392256. doi: 10.1155/2022/4392256. eCollection 2022.

  PMID: 35979399 BACKGROUND

• Benatrehina PA, Pan L, Naman CB, Li J, Kinghorn AD. Usage, biological activity, and safety of selected botanical dietary supplements consumed in the United States. J Tradit Complement Med. 2018 Mar 2;8(2):267-277. doi: 10.1016/j.jtcme.2018.01.006. eCollection 2018 Apr.

  PMID: 29736381 BACKGROUND

• Zhou H, Zhou L, Li B, Yue R. Anti-cyclooxygenase, anti-glycation, and anti-skin aging effect of Dendrobium officinale flowers' aqueous extract and its phytochemical validation in aging. Front Immunol. 2023 Mar 17;14:1095848. doi: 10.3389/fimmu.2023.1095848. eCollection 2023.

  PMID: 37006297 BACKGROUND

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Yun Wang, MD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlie Zhang, MD

CONTACT

+8613901981272; charlie.zhang@sprimmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 13, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 30, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)