Clinical trial NCT06074276: The Effects of Almond on Facial Skin Collagen and Wrinkles
Official title: Prospective Randomized Controlled Trial on the Effects of Almond on Facial Skin Collagen and Wrinkles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Collagen Degeneration
Wrinkle
Pigmentation
Elastic Skin
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Skin collagen and elastin quantification
timeFrame: 24 weeks
measure: Facial wrinkles
timeFrame: 24 weeks
Secondary outcomes:
measure: Pigment intensity score
timeFrame: 12 Weeks
measure: Pigment intensity score
timeFrame: 24 Weeks
measure: Expression of enzymes that either degrade collagen (MMP1) or inhibit collagen degradation (TIMP1) on skin biopsies
timeFrame: 24 Weeks
measure: Plasma for potential AGE (advanced glycation end products) analysis
timeFrame: 12 Weeks
measure: Plasma for potential AGE (advanced glycation end products) analysis
timeFrame: 24 Weeks
measure: Facial Wrinkles
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
affiliation: Integrative Skin Science and Research
name: Raja Sivamani, MD MS AP
role: PRINCIPAL_INVESTIGATOR
References: