The Effect of Almonds on Skin Lipids and Wrinkles

NCT02954315 | Completed

• 1 other identifier: 930524
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhytides

Outcome Measures

Primary Outcomes (1)

• Change in wrinkle depth

  16 weeks

Secondary Outcomes (4)

• Change in clinical appearance of facial wrinkles on lateral canthi

  16 weeks

• Change in facial sebum production through the use of a Sebumeter

  16 weeks

• Change in serum and sebum lipid profiles

  16 weeks

• 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

Study Arms (2)

Almond arm

EXPERIMENTAL

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

Western diet Snack (Granola bar + Pretzels)

NO INTERVENTION

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.

Interventions

Almonds OTHER

Almond arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women
• Fitzpatrick skin types 1 and 2
• Able to follow dietary intervention and attend all study visits

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Department of Dermatology, Clinical Trials Unit

Sacramento, California, 95816, United States

Location

Related Publications (1)

• 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.

  PMID: 26148924 BACKGROUND

Study Officials

• Raja K Sivamani, M.D.

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 3, 2016
• Study Start: October 25, 2016
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

US (1)