The Effects of Almond on Facial Skin Collagen and Wrinkles

Study Overview
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Brief Summary
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Investigate the effects of almond consumption on collagen production, elastin levels, wrinkles, and pigmentation among premenopausal women and postmenopausal women belonging to all Fitzpatrick skin types.

Detailed Description
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Almonds are energy-dense and rich in beneficial nutrients including B vitamins, vitamin E, mono- and polyunsaturated fatty acids, protein, fiber, minerals and polyphenols. Polyphenols and vitamin E in almonds provide protection to the body in part, through their ability to combat oxidative stress. Clinical studies have demonstrated beneficial effects of almond consumption on diseases such as diabetes and cardiovascular disease. Almond consumption has been shown to significantly decrease wrinkle severity in two clinical studies conducted with postmenopausal women with Fitzpatrick skin type I and II. Almond intake has also been shown to increase resistance to erythema induced by ultraviolet exposure. The extracellular matrix contains proteins including collagen and elastin, which contributes to the integrity of the skin. Enzymatic and ultraviolet radiation induced degradation and a reduction in synthesis of collagen and elastin contribute to wrinkle formation. Furthermore, the process of menopause decreases the level of estrogen which affects the skin in several ways, including a decrease in skin collagen and hydration, and an increase in wrinkling.

Official Title
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Prospective Randomized Controlled Trial on the Effects of Almond on Facial Skin Collagen and Wrinkles

Conditions
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Wrinkle, Collagen Degeneration, Pigmentation, Elastic Skin

Intervention / Treatment
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* Other: Food: whole almonds
* Other: Food: non-nut snack


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 35 to 70 years of age of all skin types 50% of the subjects will be postmenopausal women determined as >1-year loss of menstrual period 50% of the subjects will be premenopausal women BMI 18.5 - 35 kg/m2 Individuals with a habitual diet that has been maintained for at least 6 months and to be maintained for the duration of the study Individuals must maintain their usual skincare products, defined as products that has been used for at least 1 month, for the duration of the study Exclusion Criteria: Those with a nut allergy Those who are unwilling to discontinue oral collagen supplementation 1 month prior to the start of the study Individuals who are unwilling to discontinue vitamin E or nut containing supplements 2 weeks prior to and during the intervention. Individuals who are pregnant or breastfeeding Change in skincare products during the study Had a medical or cosmetic procedure such as laser resurfacing or plastic surgery to the face within the last 6 months (include botulinum toxin, dermal fillers, collagen, or other similar cosmetic procedure) Has an autoimmune photosensitive condition or known genetic condition with a deficiency in collagen production (such as Ehler-Danlos) Those with a skin disease on their face that would affect the assessment of their skin based on the assessment of the investigator. Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almonds<br>Consumption of almonds 5 times per week | Other: Food: whole almonds<br>* 60 grams or ( 2 oz) will be consumed 5 times per week.<br>|
| Placebo Comparator: Control Snack<br>Consumption of protein and calorie matched non-nut-based food 5 times per week | Other: Food: non-nut snack<br>* Protein and calorie matched non-nut-based food will be consumed 5 times per week by mouth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin collagen and elastin quantification | Assess with biopsy based histological examination | 24 weeks | 
| Facial wrinkles | Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system) | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pigment intensity score | Change in the appearance of facial pigmentation by high resolution photography (BTBP Clarity Pro) and measures intensity of facial pigmentation. Higher scores indicate darker pigmentation. | 12 Weeks | 
| Pigment intensity score | Change in the appearance of facial pigmentation by high resolution photography (BTBP Clarity Pro) and measures intensity of facial pigmentation. Higher scores indicate darker pigmentation. | 24 Weeks | 
| Expression of enzymes that either degrade collagen (MMP1) or inhibit collagen degradation (TIMP1) on skin biopsies | Assess through biopsy based histological examination | 24 Weeks | 
| Plasma for potential AGE (advanced glycation end products) analysis | Blood samples will be collected | 12 Weeks | 
| Plasma for potential AGE (advanced glycation end products) analysis | Blood samples will be collected | 24 Weeks | 
| Facial Wrinkles | Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system) | 12 Weeks |