PhotoagingNCT04871750
Effects of Dietary Soy Protein on Facial Wrinkles in Postmenopausal Women
A study testing Soy protein and Casein protein in people with Photoaging, run by Integrative Skin Science and Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- Soy protein and Casein protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Randomized Controlled Study on the Effects of Dietary Soy Protein on Facial
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
- Being tested
- Soy protein, Casein protein
- Keywords
- Facial Wrinkles, Soy-derived isoflavone, Short-chain fatty acids, Gut microbiome, Dermatology, Supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy proteinDietary supplement
Daily consumption for 24 weeks
Casein proteinDietary supplement
Daily consumption for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Soy protein | Experimental | 30 g powder/day, contains 50 mg of isoflavones Receives: Dietary Supplement: Soy protein |
| Casein protein | Placebo comparator | 30 g powder/day, no isoflavones Receives: Dietary Supplement: Casein protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial wrinkles
Wrinkle severity score measured by Facial Image Analysis System
Measured: week 24
Secondary outcomes (7)
Procollagen I expression
Assess with biopsy (optional participation)
Measured: 24
Pigment intensity score
Measured by the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA)
Measured: week 24
Blood levels of soy isoflavones and metabolites
Blood samples will be collected
Measured: week 24
Gut microbiome
Evaluate changes in the gut microbiome (Bifidobacteria and Lactobacilli, ratio of Firmicutes to Bacteroidetes) through stool samples
Measured: week 24
Blood lipidome
Assess changes in butyrate, propionate, and acetate levels
Measured: week 24
Facial wrinkles
Wrinkle score measured by Facial Image Analysis System
Measured: week 8
Facial wrinkles
Wrinkle score measured by Facial Image Analysis System
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start15 Jun 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy postmenopausal women aged 50 to 70, with Fitzpatrick skin type I or II.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United Soybean Board
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871750
- Sponsor's protocol ID
- SYW_01
- Status last verified
- May 2021
- First submitted
- 28 Apr 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Controlled Study on the Effects of Dietary Soy Protein on Facial
- ClinicalTrials.gov ID
- NCT04871750
- Acronym / sponsor ID
- SYW_01
- Conditions
- Photoaging
- Keywords
- Facial Wrinkles, Soy-derived isoflavone, Short-chain fatty acids, Gut microbiome, Dermatology, Supplementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- United Soybean Board
- Study start
- 15 Jun 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Healthy postmenopausal women aged 50 to 70, with Fitzpatrick skin type I or II.
| Arm | Type | Receives |
|---|---|---|
| Soy protein | Experimental | Dietary Supplement: Soy protein30 g powder/day, contains 50 mg of isoflavones |
| Casein protein | Placebo comparator | Dietary Supplement: Casein protein30 g powder/day, no isoflavones |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy proteinDaily consumption for 24 weeks | Dietary supplement | Soy protein |
| Casein proteinDaily consumption for 24 weeks | Dietary supplement | Casein protein |
Primary outcome
Facial wrinkles
Time frame: week 24
Wrinkle severity score measured by Facial Image Analysis System
7 secondary outcomes
Procollagen I expression
Time frame: 24
Pigment intensity score
Time frame: week 24
Blood levels of soy isoflavones and metabolites
Time frame: week 24
Gut microbiome
Time frame: week 24
Blood lipidome
Time frame: week 24
Facial wrinkles
Time frame: week 8
Facial wrinkles
Time frame: week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Soy protein and Casein protein in people with Photoaging, run by Integrative Skin Science and Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raja K Sivamani, MD ((916) 524-1216, raja.sivamani@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial wrinkles (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.