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| Name | Class |
|---|---|
| Eurofins Dermscan Pharmascan | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| soy isoflavones | Experimental | One oral capsule daily containing 200mg soy isoflavones for 84 days |
|
| placebo | Placebo Comparator | One oral capsule daily containing equivalent placebo for 84 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soy isoflavones | Dietary Supplement | 1 capsule daily for 84 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 42 |
| Change in Crow's Feet wrinkles (Rz) |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary isoflavones and metabolites | To quantify levels of key isoflavones and metabolites in urine | day 0, day 42, day 84 |
| Equol-producing status | To identify equol-producing individuals based on urine levels of equol |
Inclusion Criteria:
Exclusion Criteria:
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 participating in any other clinical study or being in an exclusion period for a previous study.
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.
Subject under anti-coagulant treatment.
Subject under thyroid hormones treatment.
Subject under osteoporosis treatment other than vitamin D and calcium.
Subject having started or stopped supplements used to treat menopausal symptoms, which may affect measured parameters, such as phytoestrogens, Black Cohosh, dehydroepiandrosterone (DHEA), hyaluronic acid, collagen, NADH, resveratrol soy supplements, etc. within one month prior to screening.
Subject having received injection with botulinum toxin on Crow's feet wrinkles in the year before the screening visit.
Subject having received injection with botulinum toxin on other zone of the face in the past 6 months before the screening visit.
Subject having received injection of filling product on the studied zones (crow's feet and under eye wrinkles, cheekbones and forearms) in the year before the screening visit.
Subject having received tensor threads on the face in the two years before the screening visit.
Subject having received injection of mesotherapy in the face in the past 3 months before the screening visit.
Subject having received professional peeling on the face and forearms in the past 3 months before the screening visit.
Subject having received a treatment with a laser on the face or forearms in the past 6 months before the screening visit.
Subject under oral hormonal substitutive treatment during the year previous the screening visit.
Subject receiving any long-term medical treatment or any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject at undue risk.
Subject undergoing a topical treatment on the test area (forearms and face) or a systemic treatment:
Intensive exposure to sunlight within the previous month and foreseen during the study without adequate sun protection, as per the investigator's judgement.
Exposure to artificial UV or spray tan in the month preceding the screening or during the study.
Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Dermscan Pharmascan | Villeurbanne | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41256931 | Derived | 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. |
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| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
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| Placebo |
| Dietary Supplement |
1 capsule daily for 84 days |
|
Cutaneous relief parameters (Rz - Average height of the roughness) on Crow's Feet wrinkles measured with fringe projection acquisitions
| day 0, day 42, day 84 |
| Change in Crow's Feet wrinkles (Rt) | Cutaneous relief parameters (Rt - Maximum height of the roughness profile) on Crow's Feet wrinkles measured with fringe projection acquisitions | day 0, day 42, day 84 |
| Change in under eye wrinkles (Ra) | Cutaneous relief parameters (Ra - Average roughness) on under eye wrinkles measured with fringe projection acquisitions | day 0, day 42, day 84 |
| Change in under eye wrinkles (Rt) | Cutaneous relief parameters (Rt - Maximum height of the roughness profile) on under eye wrinkles measured with fringe projection acquisitions | day 0, day 42, day 84 |
| Change in under eye wrinkles (Rz) | Cutaneous relief parameters (Rz - Average height of the roughness) on under eye wrinkles measured with fringe projection acquisitions | day 0, day 42, day 84 |
| Change in skin hydration | Skin hydration will be evaluated by Corneometer® on the forearm. | day 0, day 42, day 84 |
| Change in skin colour | Skin colour will be evaluated by Spectrophotometer® on the cheekbone. | day 0, day 42, day 84 |
| Change in skin barrier function | Skin barrier function will be evaluated by the measurement of Trans Epidermal Water Loss with Aquaflux® on the forearm | day 0, day 42, day 84 |
| Subject satisfaction | A non-validated subjective evaluation questionnaire on the study product's effects on the skin will be completed by subjects (each item is scored individually on a 5 point Likert scale ranging from 'Totally agree' to 'Totally disagree') | day 42, day 84 |
| Adverse events | Collection of adverse events throughout the study | day 0, day 42, day 84 |
| day 0, day 42, day 84 |
| D004044 |
| Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |