The Effect of Almonds on Skin Lipids and Wrinkles

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

Tracking Information

• First Submitted Date: November 1, 2016
• First Posted Date: November 3, 2016
• Last Update Posted Date: October 17, 2018
• Actual Study Start Date: October 25, 2016
• Actual Primary Completion Date: April 30, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 1, 2016): Change in wrinkle depth [ Time Frame: 16 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 1, 2016)

• Change in clinical appearance of facial wrinkles on lateral canthi [ Time Frame: 16 weeks ]
• Change in facial sebum production through the use of a Sebumeter [ Time Frame: 16 weeks ]
• Change in serum and sebum lipid profiles [ Time Frame: 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 [ Time Frame: 16-weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Almonds on Skin Lipids and Wrinkles
• Official Title: The Effect of Almonds on Skin Lipids and Wrinkles
• 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.

Detailed Description

Primary Endpoint:

A) Change in wrinkle depth. Full facial photographs will be obtained at baseline, 8 weeks, and 16 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. This system can assess average wrinkle depth. The PI has already validated this measurement tool against standard clinical grading of facial wrinkles[13].

Secondary Endpoint:

A) Change in clinical appearance of facial wrinkles on lateral canthi: Two blinded dermatologists will grade the photographs obtained at each of the time points on the lateral canthi ("crow's feet"). The dermatologists will not know which group the subjects were in.

B) Change in facial sebum production through the use of a Sebumeter, a commonly used device that measures sebum excretion rate [13,17]. Sebum excretion rate will be measured at baseline, 8 weeks, and 16 weeks.

C) Change in serum and sebum lipid profiles obtained through the use of Sebutapes at baseline, 8 weeks, and 16 weeks.

D) Change in the serum and sebum lipid profile for assessment of long chain/short chain fatty acid ratios and the NS ceramide content.

Procedures Involved This study will be a 16-week supplementation study that utilizes two study groups: 1) Control group 2) Almond supplementation: 20% energy intake. This will be a randomized, rater-blinded, controlled study.

There will be a total of 30 subjects:

Control Group: n=15 Almond Supplementation: n=15

The subjects will be recruited from the UC Davis Dermatology Department, the surrounding clinics in a 25 mile radius, and the general population in the Davis and Sacramento areas. The greater Sacramento area has a population of over 2 million to draw from and recruitment will be conducted through the use of Social Media and flyer based recruitment.

Investigators will collect medical history and current medications from study participants- this is outlined in the HIPAA form. The two intervention groups will consist of those receiving almonds and those that are receiving a calorie matched snack. 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 of tree nuts [23,24]. The control snack will be a typical western diet snack. The calorie-matched control snack will be commercially available individually wrapped food products such as a small granola bar + pretzels. Once a subject has met inclusion criteria and has signed IRB consent, anthropometric data will be obtained, 3-24 hour recall will be collected by phone, skype, or in person by a Registered Dietitian, training will be provided for recording dietary records, and estimated caloric needs will be calculated. Estimated energy needs (EER) will be determined using the Mifflin-St. Jeor equation and total daily energy needs (TDE) calculated as EER x activity factor of 1.3-1.5 for sedentary to average activity, or a higher activity level as indicated. A representative example of a 60 year old woman, 5'4", 140 pounds with typical activity level yields TDE of approximately 1,600 - 1,800 kcal/day, and 20% E of 320-360 kcal/day. The dose of almonds would be 2 ounces (equal to 23 whole kernels)/day, providing 328 calories.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Rhytides
• Intervention: Other: Almonds

Study Arms

• 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.
  Intervention: 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.

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 15, 2018): 31
• Original Estimated Enrollment (submitted: November 1, 2016): 30
• Actual Study Completion Date: April 30, 2018
• Actual Primary Completion Date: April 30, 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02954315
• Other Study ID Numbers: 930524
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of California, Davis
• Original Responsible Party: Raja Sivamani, MD, University of California, Davis, Assistant Professor of Clinical Dermatology
• Current Study Sponsor: University of California, Davis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Raja K Sivamani, M.D.; UC Davis

• PRS Account: University of California, Davis
• Verification Date: October 2018