Effects of Dietary Soy Protein on Facial Wrinkles in Postmenopausal Women

• ClinicalTrials.gov Identifier: NCT04871750
• Recruitment Status: Not yet recruiting
• First Posted: May 4, 2021
• Last Update Posted: May 20, 2021
• Sponsor: Integrative Skin Science and Research
• Collaborator: United Soybean Board
• Information provided by (Responsible Party): Integrative Skin Science and Research

Study Description

Brief Summary:

Soy and soy-derived products are the primary dietary sources of isoflavones, particularly daidzein and genistein, for humans. Isoflavones are noted to have several effects on the skin including proliferation of keratinocytes resulting in epidermal thickening and increasing collagen and moisture content of the skin. Previous work has shown that the ingestion of an oral supplement containing soy isoflavones as a component led to a clinically measurable improvement in wrinkle depth after 14 weeks of supplementation.

Ingestion of soy-based products has been shown to shift the Bifidobacteria and Lactobacilli among the gut microbiota and modulate the ratio of Firmicutes to Bacteroidetes. Many studies have shown that short-chain fatty acids result from beneficial shifts in the gut microbiome and may influence the inflammatory state of the skin.

Therefore, the study aims to investigate whether soy-derived isoflavone can reduce wrinkles and alter both gut microbiome and short-chain fatty acids.

Condition or disease	Intervention/treatment	Phase
Photoaging	Dietary Supplement: Soy protein; Dietary Supplement: Casein protein	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Healthy postmenopausal women aged 50 to 70, with Fitzpatrick skin type I or II.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized Controlled Study on the Effects of Dietary Soy Protein on Facial
• Estimated Study Start Date: June 15, 2021
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: June 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Soy protein; 30 g powder/day, contains 50 mg of isoflavones	Dietary Supplement: Soy protein; Daily consumption for 24 weeks
Placebo Comparator: Casein protein; 30 g powder/day, no isoflavones	Dietary Supplement: Casein protein; Daily consumption for 24 weeks

Outcome Measures

Primary Outcome Measures :

1. Facial wrinkles [ Time Frame: week 24 ]
   Wrinkle severity score measured by Facial Image Analysis System

Secondary Outcome Measures :

1. Procollagen I expression [ Time Frame: 24 ]
   Assess with biopsy (optional participation)
2. Pigment intensity score [ Time Frame: week 24 ]
   Measured by the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA)
3. Blood levels of soy isoflavones and metabolites [ Time Frame: week 24 ]
   Blood samples will be collected
4. Gut microbiome [ Time Frame: week 24 ]
   Evaluate changes in the gut microbiome (Bifidobacteria and Lactobacilli, ratio of Firmicutes to Bacteroidetes) through stool samples
5. Blood lipidome [ Time Frame: week 24 ]
   Assess changes in butyrate, propionate, and acetate levels
6. Facial wrinkles [ Time Frame: week 8 ]
   Wrinkle score measured by Facial Image Analysis System
7. Facial wrinkles [ Time Frame: week 16 ]
   Wrinkle score measured by Facial Image Analysis System

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Postmenopausal females, 50 to 70 years of age
• Fitzpatrick skin type I or II, based on skin melanin content
• BMI 18.5-35 kg/m2
• Must be willing to comply with all protocol requirements
• Must be willing to have flash photo facial images taken with the imaging systems

Exclusion Criteria:

• Any systemic or antibiotics (injected or oral) within 6 months of starting study
• Any topical antibiotic or benzoyl peroxide within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or benzoyl peroxide ingredient.
• Allergic to soy and milk products
• Fruit consumption > 2 cups/day
• Vegetable consumption > 3 cups/day for females
• Fruit juice consumption > 1 cup/day
• Coffee consumption > 1 cup per day
• Alcohol consumption ≥ 3 servings per week (1 serving = 1 bottle of beer, ½ glass of wine, or 1 shot of hard liquor)
• Self-reported malabsorption
• Any oral probiotic or prebiotic supplementation within past 1 month at the discretion of the investigator. Probiotic and prebiotic containing foods are NOT considered an exclusion.
• Subjects must have no history of malignancy or cancer or diagnosis of gastrointestinal inflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis)
• Has a condition or is on medication the investigator and/or designee believe could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results
• Is participating in a concurrent intervention based clinical research study
• Commencement of a new diet (such as the ketogenic diet) or supplements within the 1 month prior to initiating participation, at the discretion of the investigator.
• Use of medications that alter blood lipids, such as statins and anti-hyperlipidemic medications
• Is participating in or has participated in a intervention based facial study at this or any other facility in the past 2 weeks. Participation in survey-based studies are approved at the discretion of the investigator.
• Has a skin disease on face that will interfere with image collection and assessment in the opinion of the investigator
• Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, sun tanning, or artificial tanning.
• Planned vacation to sunny destination with the intention of sun tanning during the duration of the study.
• Persons who regularly undergo sauna treatments (dry or wet) or who swim daily. Known allergy or irritation to the supplement or facial products utilized in the study
• Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
• Prisoners
• Adults unable to consent
• Vegans and vegetarians

Contacts and Locations

Contacts

Contact: Raja K Sivamani, MD; (916) 524-1216; raja.sivamani@integrativeskinresearch.com

Contact: Vivien W Fam, RD; (530) 760-5968; vivien@integrativeskinresearch.com

Sponsors and Collaborators

Integrative Skin Science and Research

United Soybean Board

More Information

• Responsible Party: Integrative Skin Science and Research
• ClinicalTrials.gov Identifier: NCT04871750
• Other Study ID Numbers: SYW_01
• First Posted: May 4, 2021
• Last Update Posted: May 20, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Integrative Skin Science and Research:

Facial Wrinkles; Soy-derived isoflavone; Short-chain fatty acids; Gut microbiome; Dermatology; Supplementation

Additional relevant MeSH terms:

Caseins; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action