The Effect of Almonds on Facial Aesthetics and Modulation of the Microbiome and Lipidome

NCT03729700 | Completed DMC

• 1 other identifier: 1257688
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator hypothesizes that regular consumption of almonds will 1) improve the facial wrinkle severity in post-menopausal women, 2) improve the evenness of facial skin pigmentation, 3) diversify the gut microbiome and increase the short chain fatty acids in the blood, and 4) improve the skin barrier biophysical properties.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• Change in wrinkle severity

  Photographs will be obtained at baseline, 8 weeks, 16 weeks, and 24 weeks. The images will be obtained with the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA) that has standardized positioning and lighting and iPad. The investigator has already validated this measurement tool against standard clinical grading of facial wrinkles.

  24 weeks

Secondary Outcomes (5)

• Change in facial pigmentation

  24 weeks

• Change in appearance of facial wrinkles on lateral canthi

  24 weeks

• Change in facial sebum production

  24 weeks

• Change in the serum profile

  24 weeks

• Change in sebum lipid profile

  24 weeks

Study Arms (2)

Almond supplementation

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: Almond

Control snack

NO INTERVENTION

The control snack will be a typical western diet snack. The calorie-matched control snack will be commercially available individually wrapped food products.

Interventions

Almond OTHER

The almond dose will be provided as 20% of total energy (20% E) in the diet.

Almond supplementation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Post-menopausal women
• Healthy Volunteers: No
• 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
• Current smokers, those that have smoked within the past year, and former smokers with greater than a 20 pack-year history of smoking, as smoking is a independent risk factor and serves as a confounder for the development of facial wrinkles
• Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehler-Danlos), as this can be a confounder for the development of facial wrinkles
• 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 vitamin E containing supplements and food sources 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

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: October 30, 2018
• First Posted: November 5, 2018
• Study Start: October 22, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 22, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

US (1)