The Effects of Almond on Facial Skin Collagen and Wrinkles

Not Applicable

Recruiting

• Conditions: Elastic Skin; Collagen Degeneration; Wrinkle; Pigmentation

• Registration Number: NCT06074276
• Lead Sponsor: Integrative Skin Science and Research

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-10-03
• Study Start: 2023-10-04
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-15
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Skin collagen and elastin quantification	24 weeks	Assess with biopsy based histological examination
Facial wrinkles	24 weeks	Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system). Higher scores indicate worsened wrinkle severity and lower scores represent improvement in wrinkle severity.

Secondary Outcome Measures

Name	Time	Method
Facial Wrinkles	12 Weeks	Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system). Higher scores indicate worsened wrinkle severity and lower scores represent improvement in wrinkle severity.
Pigment intensity score	24 Weeks	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.
Plasma for potential AGE (advanced glycation end products) analysis	24 Weeks	Blood samples will be collected
Expression of enzymes that either degrade collagen (MMP1) or inhibit collagen degradation (TIMP1) on skin biopsies	24 Weeks	Assess through biopsy based histological examination

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States