The Effects of Almond on Facial Skin Collagen and Wrinkles

NCT ID: NCT06074276

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-04

Study Completion Date

2024-12-31

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.

Conditions

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Collagen Degeneration Wrinkle Pigmentation Elastic Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Almonds

Consumption of almonds 5 times per week

Group Type EXPERIMENTAL

Food: whole almonds

Intervention Type OTHER

60 grams or (\~2 oz) will be consumed 5 times per week.

Control Snack

Consumption of protein and calorie matched non-nut-based food 5 times per week

Group Type PLACEBO_COMPARATOR

Food: non-nut snack

Intervention Type OTHER

Protein and calorie matched non-nut-based food will be consumed 5 times per week by mouth

Interventions

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Food: whole almonds

60 grams or (\~2 oz) will be consumed 5 times per week.

Intervention Type OTHER

Food: non-nut snack

Protein and calorie matched non-nut-based food will be consumed 5 times per week by mouth

Intervention Type OTHER

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Integrative Skin Science and Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raja Sivamani, MD MS AP

Role: PRINCIPAL_INVESTIGATOR

Integrative Skin Science and Research

Locations

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Integrative Skin Science and Research

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Adnan

Role: CONTACT

9168074299

Facility Contacts

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Nasima Afzal

Role: primary

916-750-2463

Other Identifiers

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i23-07_Almond_Collagen

Identifier Type: -

Identifier Source: org_study_id

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