Rhytides Clinical Trial
Official title:
The Effect of Almonds on Skin Lipids and Wrinkles
NCT number | NCT02954315 |
Other study ID # | 930524 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 25, 2016 |
Est. completion date | April 30, 2018 |
Verified date | October 2018 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators hypothesize that regular consumption of almonds will augment the long chain fatty acid profile and the alpha-tocopherol levels, improve the skin barrier function, and improve the appearance of facial wrinkles in post-menopausal women.
Status | Completed |
Enrollment | 31 |
Est. completion date | April 30, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Postmenopausal women - Fitzpatrick skin types 1 and 2 - Able to follow dietary intervention and attend all study visits Exclusion Criteria: - Those with a nut allergy - Smoking: - Current smokers - Those that have smoked within the past year - Former smokers with greater than a 20 pack-year history of smoking within the past 20 years will be excluded. - Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehler-Danlos) - Those that already obtain 20% of their energy intake from nut consumption - Those with implausible reported energy intakes of <1,000 kcal/d or >3,000 kcal/d - Individuals who are unwilling to discontinue high antioxidant supplements and daily food sources listed below, during the washout and intervention. |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis Department of Dermatology, Clinical Trials Unit | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Alasalvar C, Bolling BW. Review of nut phytochemicals, fat-soluble bioactives, antioxidant components and health effects. Br J Nutr. 2015 Apr;113 Suppl 2:S68-78. doi: 10.1017/S0007114514003729. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in wrinkle depth | 16 weeks | ||
Secondary | Change in clinical appearance of facial wrinkles on lateral canthi | 16 weeks | ||
Secondary | Change in facial sebum production through the use of a Sebumeter | 16 weeks | ||
Secondary | Change in serum and sebum lipid profiles | 16 weeks | ||
Secondary | Change in the serum and sebum lipid profile for assessment of long chain/short chain fatty acid ratios and the NS ceramide content | 16-weeks |
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