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The Effect of Almonds on Skin Lipids and Wrinkles

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ClinicalTrials.gov Identifier: NCT02954315
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rhytides Other: Almonds Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Almonds on Skin Lipids and Wrinkles
Actual Study Start Date : October 25, 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Arm Intervention/treatment
Experimental: Almond arm
The almond dose will be provided as 20% of total energy (20% E) in the diet. This dose was selected based on a previous randomized trial examining lipid parameters in response to 0, 10%, and 20% E as dietary almonds and a recent meta-analysis of intervention trials.
Other: Almonds
No Intervention: Western diet Snack (Granola bar + Pretzels)
The control snack will be a typical western diet snack (see Table 1). The calorie-matched control snack will be commercially available individually wrapped food products such as a small granola bar + pretzels.



Primary Outcome Measures :
  1. Change in wrinkle depth [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Change in clinical appearance of facial wrinkles on lateral canthi [ Time Frame: 16 weeks ]
  2. Change in facial sebum production through the use of a Sebumeter [ Time Frame: 16 weeks ]
  3. Change in serum and sebum lipid profiles [ Time Frame: 16 weeks ]
  4. Change in the serum and sebum lipid profile for assessment of long chain/short chain fatty acid ratios and the NS ceramide content [ Time Frame: 16-weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954315


Locations
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United States, California
UC Davis Department of Dermatology, Clinical Trials Unit
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Raja K Sivamani, M.D. UC Davis
Publications:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02954315    
Other Study ID Numbers: 930524
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018