Effects of Dietary Soy Protein on Facial Wrinkles in Postmenopausal Women

NCT04871750 | Unknown

• 1 other identifier: SYW_01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Photoaging

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Facial wrinkles

  Wrinkle severity score measured by Facial Image Analysis System

  week 24

Secondary Outcomes (7)

• Procollagen I expression

  24

• Pigment intensity score

  week 24

• Blood levels of soy isoflavones and metabolites

  week 24

• Gut microbiome

  week 24

• Blood lipidome

  week 24

Study Arms (2)

Soy protein

EXPERIMENTAL

30 g powder/day, contains 50 mg of isoflavones

Dietary Supplement: Soy protein

Casein protein

PLACEBO COMPARATOR

30 g powder/day, no isoflavones

Dietary Supplement: Casein protein

Interventions

Soy protein DIETARY_SUPPLEMENT

Daily consumption for 24 weeks

Soy protein

Casein protein DIETARY_SUPPLEMENT

Daily consumption for 24 weeks

Casein protein

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• United Soybean Board: collaborator

MeSH Terms

Interventions

Soybean Proteins

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Central Study Contacts

Raja K Sivamani, MD

CONTACT

(916) 524-1216; raja.sivamani@integrativeskinresearch.com

Vivien W Fam, RD

CONTACT

(530) 760-5968; vivien@integrativeskinresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy postmenopausal women aged 50 to 70, with Fitzpatrick skin type I or II.

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 4, 2021
• Study Start: June 15, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share