The Effect of Almonds on Facial Aesthetics and Modulation of the Microbiome and Lipidome
Condition: Wrinkle
Study type: Interventional

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.
    

Detailed description: 
      This study will be a 24 week supplementation study that utilizes two study groups: 1) control
      group and 2) almond supplementation: 20% energy intake. This will be a randomized,
      rater-blinded, and controlled study. There will be a total of 60 subjects, with 30 assigned
      to the control group and 30 assigned to almond supplementation.

      Subjects will be recruited from the UC Davis Dermatology Clinic, UC Davis Main campus,
      California State University- Sacramento, and from the surrounding community physicians and
      the community in a 100 mile radius. 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. Postmenopausal women have previous been recruited successfully in a
      previous study. The study visits will be performed at the UC Davis Dermatology Clinic located
      at 3301 C Street, Suite 1400, Sacramento, CA 95816.

      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 [5, 6]. The
      control snack will be a typical western diet snack (see Table 1) . The calorie matched snacks
      are commercially available prepackaged snack items that will be purchased from Costco. Once a
      subject has met inclusion criteria and has signed IRB consent, anthropometric data will be
      obtained, 1-24 hour recall will be collected, 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 intervention and control snacks would be 56.7 g of almonds and 56.7 g
      pretzel + one-24 g chewy granola bar, respectively.
    

Intervention name(s): Almond
Intervention type(s): Other
Intervention description(s): The almond dose will be provided as 20% of total energy (20% E) in the diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science