Evaluation of Soy Isoflavones on Skin Ageing Parameters

NCT06047145 | Completed

• 1 other identifier: CTB2022TN110
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This double-blind, placebo-controlled, randomised pilot trial aims to assess the effect of oral soy isoflavone consumption on skin ageing parameters in post-menopausal women.

Conditions

Skin Ageing

Keywords

soy isoflavones; skin ageing; menopause

Outcome Measures

Primary Outcomes (1)

• Change in Crow's Feet wrinkles (Ra)

  Cutaneous relief parameters (Ra - Average roughness) on Crow's Feet wrinkles measured with fringe projection acquisitions

  day 0, day 84

Secondary Outcomes (11)

• Change in Crow's Feet wrinkles (Ra)

  day 0, day 42

• Change in Crow's Feet wrinkles (Rz)

  day 0, day 42, day 84

• Change in Crow's Feet wrinkles (Rt)

  day 0, day 42, day 84

• Change in under eye wrinkles (Ra)

  day 0, day 42, day 84

• Change in under eye wrinkles (Rt)

  day 0, day 42, day 84

Other Outcomes (2)

• Urinary isoflavones and metabolites

  day 0, day 42, day 84

• Equol-producing status

  day 0, day 42, day 84

Study Arms (2)

soy isoflavones

EXPERIMENTAL

One oral capsule daily containing 200mg soy isoflavones for 84 days

Dietary Supplement: soy isoflavones

placebo

PLACEBO COMPARATOR

One oral capsule daily containing equivalent placebo for 84 days

Dietary Supplement: Placebo

Interventions

soy isoflavones DIETARY_SUPPLEMENT

1 capsule daily for 84 days

soy isoflavones

Placebo DIETARY_SUPPLEMENT

1 capsule daily for 84 days

placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subject.
• Sex: female.
• Age: from 40 to 65 years (inclusive).
• Phototype: I to IV on the Fitzpatrick scale.
• Post-menopausal subject, with last menstrual period at least 12 months prior to screening and who is not using hormonal contraception.
• Subject having Crow's feet wrinkles from grade 2 to 5 on Bazin's scale.
• Subject having under eyes wrinkles.
• Subject agreeing not to change her alimentary and cosmetic habits during the study.
• Subject, able to understand the study related information and to give a written informed consent.
• Subject having given freely and expressly informed consent.
• Subject able and willing to comply with protocol requirements.
• Subject affiliated to a health social security system.

You may not qualify if:

• Women with childbearing potential or women on long term hormonal contraception whose childbearing potential is difficult to ascertain.
• Subject deprived of her freedom by administrative or legal decision.
• Subject under guardianship or unable to provide consent.
• Subject in a social or healthcare institution.
• Subject suspected to be non-compliant according to the investigator's judgment.
• Subject having crow's feet wrinkles with grades \< 2 or \> 5 on Bazin's scale.
• Subject with a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation.
• Personal or family history of breast, uterine or ovarian cancer as per investigator judgement.
• Subject with personal history of cancer.
• Subject with a condition or receiving a medication which, in the investigator's judgement, put the subject at undue risk.
• Subject suffering from a severe or progressive disease, likely to interfere with the measured parameters.
• Subject with any skin or systemic disease (acute and/or chronic), ongoing or in the previous year, likely to interfere with the measured parameters or to put the subject at undue risk.
• Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
• Subject with allergies or intolerance to soy or soy products.
• Subject having history of allergy or hypersensitivity to any of the components of the tested product.

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• Eurofins Dermscan Pharmascan: collaborator

Study Sites (1)

Eurofins Dermscan Pharmascan

Villeurbanne, France

Location

Related Publications (1)

• Vijayakumar V, Climent E, Enrique M, Lamelas A, Alvarez B, Chenoll E, Naghibi M, Day R. S-equol status modulates skin response to soy isoflavones in postmenopausal women: results from a randomized placebo-controlled pilot trial. Front Nutr. 2025 Nov 3;12:1671835. doi: 10.3389/fnut.2025.1671835. eCollection 2025.

  PMID: 41256931 DERIVED

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

Study Design

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

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: October 27, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: April 10, 2025

Record last verified: 2024-03

Locations

FR (1)