The Effects of Almond on Facial Skin Collagen and Wrinkles

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

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.

Study Overview

• Status: Recruiting
• Conditions: Wrinkle; Pigmentation; Collagen Degeneration; Elastic Skin
• Intervention / Treatment: Other: Food: whole almonds; Other: Food: non-nut snack

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Adnan; Phone Number: 9168074299; Email: sarah@integrativeskinresearch.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95819
      • Recruiting
      • Integrative Skin Science and Research
      • Contact: Nasima Afzal; Phone Number: 916-750-2463; Email: nasima@integrativeskinresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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). Higher scores indicate worsened wrinkle severity and lower scores represent improvement in wrinkle severity.	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). Higher scores indicate worsened wrinkle severity and lower scores represent improvement in wrinkle severity.	12 Weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Investigators: Principal Investigator: Raja Sivamani, MD MS AP, Integrative Skin Science and Research

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 15, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Congenital Abnormalities; Hematologic Diseases; Hemorrhagic Disorders; Genetic Diseases, Inborn; Connective Tissue Diseases; Hemostatic Disorders; Skin Diseases, Genetic; Skin Abnormalities; Collagen Diseases; Ehlers-Danlos Syndrome
• Other Study ID Numbers: i23-07_Almond_Collagen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No