Skin AgingPhase 4NCT00352157
Effect of Revival Soy on Weight Loss and Skin, Hair, and Nails in Premenopausal Women
A Phase 4 study testing Revival Soy Dietary Supplement in people with Skin Aging and Weight Loss, run by Physicians Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine if dietary consumption of Revival Soy can improve the appearance of the skin, hair, and finger nails and support weight loss in overweight, premenopausal women. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Weight Loss
- What is being tested?
- Revival Soy Dietary Supplement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Mar 2007
- Phase
- Phase 4
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females
- Age: 25-45 years.
- BMI between 30 - 40 kg/m2.
- Motivated to lose weight.
- Subjects must be in general good health as determined from a medical history.
- Subjects must have mild to moderate photoaging.
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- Subjects must use a shampoo from the approved list without change for the entire duration of the study.
- Must not be consuming soy supplements or other soy products currently.
- Must not be pregnant (negative pregnancy test at screening) and agree not to become pregnant during the course of the study.
- Subjects must read and sign the informed consent form after the nature of the study has been fully explained.
Who cannot join
- Subjects with known allergies or sensitivities to ingredients contained in the dietary supplement.
- Subjects who are required to spend excessive time in the sun (i.e. lifeguards, other outdoor workers).
- Subjects who are currently participating or have participated within the last 4 weeks in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.).
- Subjects viewed by the investigator as not being able to complete the study.
- Subjects who are unwilling to leave all of their current skin care products unchanged for the 6 months of the study.
- Subjects who are unwilling to leave all of their current nail care products unchanged for the 6 months of the study.
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- Subjects who are unwilling to leave all of their current oral medications unchanged for the 6 months of the study.
- Subjects who have experienced large variations in body weight during the previous 3 months
- Subjects currently using other weight loss medications or supplements.
- Subjects who had surgical intervention for the treatment of obesity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consulting Services
High Point, North Carolina, 27262
About this study
Official title: Effect of Revival Soy on Weight Loss and Appearance of Skin, Hair, and Nails in High BMI Premenopausal Women
The purpose of this study is to determine if dietary consumption of Revival Soy can improve the appearance of the skin, hair, and finger nails and support weight loss in overweight, premenopausal women.
Read the detailed description
The researchers hypothesize that supplementation of Revival® Soy products to overweight premenopausal women as part of a soy-based meal replacement diet plan will:
- Improve the health and appearance of the skin by normalizing skin pigmentation and reducing wrinkles,
- Improve the health and appearance of hair by enhancing sheen and ease of combing, and
- Improve the health and appearance of nails by enhancing shine, flexibility, and strength.
- Stimulate a loss in weight and a reduction in the Body Mass Index (BMI),
For this study, obese (BMI = 30-40 kg/m2) premenopausal women (25-45 years of age) with mild to moderate photoaging (n=40) will receive either a Revival® soy shake (20 grams soy protein with 160 mg total isoflavones; n=20) or a placebo shake (20 grams of milk protein with 0 mg isoflavones; n=20) daily for 6 months. The subjects will be asked to come into the office for a total of seven visits, at baseline and at monthly intervals for 6 months. At baseline, month 3, and month 6, the subjects will be asked to complete a questionnaire in order to provide self-reported improvements related to hair, skin, and nail health. Following completion of the questionnaire, the investigator and the dermatology clinic staff will examine the subjects to assess the health and appearance of their skin, hair, and nails at baseline, month 3, and month 6.
After acceptance into the study, a registered dietitian will instruct the study subjects in the use of a low-energy (1,200 - 1,500 kcal/day) diet that incorporates 2 soy-based daily meal replacements (shakes, ~500 kcal), a minimum of 5 daily servings of fruits and vegetables (~300 kcal), and one entrée (~400 - 500 kcal). Subjects will be required to keep a dietary food intake record of all food and supplement use during the trial. Anthropometric data (height, body weight, waist circumference and hip circumference) will be collected at baseline and at monthly intervals.
- Conditions
- Skin Aging, Weight Loss
- Being tested
- Revival Soy Dietary Supplement
- Keywords
- Soy, Dermatology, Skin, Hair, Finger Nails, Weight Loss, Body Mass Index, Photoaging of Skin, Skin Wrinkling
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revival Soy Dietary SupplementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator assessed appearance of skin (roughness, wrinkling, dyspigmentation, and redness) at baseline and after 3 and 6 months
Investigator assessed appearance of hair (roughness, dullness, lack of manageability, and scalp flaking) at baseline and after 3 and 6 months
Investigator assessed appearance of finger nails (roughness, ridging, flaking, and splitting) at baseline and after 3 and 6 months.
Secondary outcomes (3)
Body weight at monthly intervals
Body mass index (BMI) at the baseline and study completion
Subject-perceived changes in appearance of skin, hair, and finger nails at baseline and after 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startJul 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Physicians Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, High Point NC
- Investigators
- Zoe D Draelos, M.D., Principal investigator, Dermatology Consulting Services, High Point NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352157
- Sponsor's protocol ID
- DCS-61-06
- Status last verified
- Jul 2009
- First submitted
- 13 Jul 2006
- Last updated
- 21 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Revival Soy on Weight Loss and Appearance of Skin, Hair, and Nails in High BMI Premenopausal Women
- ClinicalTrials.gov ID
- NCT00352157
- Acronym / sponsor ID
- DCS-61-06
- Conditions
- Skin Aging, Weight Loss
- Keywords
- Soy, Dermatology, Skin, Hair, Finger Nails, Weight Loss, Body Mass Index, Photoaging of Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Physicians Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, High Point NC
- Study start
- Jul 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 14 Jul 2006 (estimated)
- 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.
The purpose of this study is to determine if dietary consumption of Revival Soy can improve the appearance of the skin, hair, and finger nails and support weight loss in overweight, premenopausal women.
Detailed description
The researchers hypothesize that supplementation of Revival® Soy products to overweight premenopausal women as part of a soy-based meal replacement diet plan will:
- Improve the health and appearance of the skin by normalizing skin pigmentation and reducing wrinkles,
- Improve the health and appearance of hair by enhancing sheen and ease of combing, and
- Improve the health and appearance of nails by enhancing shine, flexibility, and strength.
- Stimulate a loss in weight and a reduction in the Body Mass Index (BMI),
For this study, obese (BMI = 30-40 kg/m2) premenopausal women (25-45 years of age) with mild to moderate photoaging (n=40) will receive either a Revival® soy shake (20 grams soy protein with 160 mg total isoflavones; n=20) or a placebo shake (20 grams of milk protein with 0 mg isoflavones; n=20) daily for 6 months. The subjects will be asked to come into the office for a total of seven visits, at baseline and at monthly intervals for 6 months. At baseline, month 3, and month 6, the subjects will be asked to complete a questionnaire in order to provide self-reported improvements related to hair, skin, and nail health. Following completion of the questionnaire, the investigator and the dermatology clinic staff will examine the subjects to assess the health and appearance of their skin, hair, and nails at baseline, month 3, and month 6.
After acceptance into the study, a registered dietitian will instruct the study subjects in the use of a low-energy (1,200 - 1,500 kcal/day) diet that incorporates 2 soy-based daily meal replacements (shakes, ~500 kcal), a minimum of 5 daily servings of fruits and vegetables (~300 kcal), and one entrée (~400 - 500 kcal). Subjects will be required to keep a dietary food intake record of all food and supplement use during the trial. Anthropometric data (height, body weight, waist circumference and hip circumference) will be collected at baseline and at monthly intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Females
- Age: 25-45 years.
- BMI between 30 - 40 kg/m2.
- Motivated to lose weight.
- Subjects must be in general good health as determined from a medical history.
Key exclusion criteria (10 listed)
- Subjects with known allergies or sensitivities to ingredients contained in the dietary supplement.
- Subjects who are required to spend excessive time in the sun (i.e. lifeguards, other outdoor workers).
- Subjects who are currently participating or have participated within the last 4 weeks in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.).
- Subjects viewed by the investigator as not being able to complete the study.
- Subjects who are unwilling to leave all of their current skin care products unchanged for the 6 months of the study.
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 |
|---|---|---|
| Revival Soy Dietary Supplement | Behavioural | – |
Primary outcome
Investigator assessed appearance of skin (roughness, wrinkling, dyspigmentation, and redness) at baseline and after 3 and 6 months
Investigator assessed appearance of hair (roughness, dullness, lack of manageability, and scalp flaking) at baseline and after 3 and 6 months
Investigator assessed appearance of finger nails (roughness, ridging, flaking, and splitting) at baseline and after 3 and 6 months.
3 secondary outcomes
Body weight at monthly intervals
Body mass index (BMI) at the baseline and study completion
Subject-perceived changes in appearance of skin, hair, and finger nails at baseline and after 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2009.
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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.
Zoe D Draelos, M.D. principal investigator
Dermatology Consulting Services, High Point NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Revival Soy Dietary Supplement in people with Skin Aging and Weight Loss, run by Physicians Pharmaceuticals, Inc. at 1 site in United States.
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 10 inclusion and 10 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: finished, as of the sponsor's last update on 21 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator assessed appearance of skin (roughness, wrinkling, dyspigmentation, and redness) at baseline and after 3 and 6 months. The study lists 3 primary outcomes in all. 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 21 Jul 2009.