The Effects of Almond on Facial Skin Collagen and Wrinkles

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074276
• Other study ID #: i23-07_Almond_Collagen
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Integrative Skin Science and Research
• Contact: Sarah Adnan
• Phone: 9168074299
• Email: sarah[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Degeneration
• Ehlers-Danlos Syndrome
• Elastic Skin
• Pigmentation
• Wrinkle

Intervention

Other:
• Food: whole almonds
60 grams or (~2 oz) will be consumed 5 times per week.
• Food: non-nut snack
Protein and calorie matched non-nut-based food will be consumed 5 times per week by mouth

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Integrative Skin Science and Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin collagen and elastin quantification	Assess with biopsy based histological examination	24 weeks
Primary	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	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
Secondary	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
Secondary	Expression of enzymes that either degrade collagen (MMP1) or inhibit collagen degradation (TIMP1) on skin biopsies	Assess through biopsy based histological examination	24 Weeks
Secondary	Plasma for potential AGE (advanced glycation end products) analysis	Blood samples will be collected	12 Weeks
Secondary	Plasma for potential AGE (advanced glycation end products) analysis	Blood samples will be collected	24 Weeks
Secondary	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