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The Effects of Almond on Facial Skin Collagen and Wrinkles

Primary Purpose

Collagen Degeneration, Wrinkle, Pigmentation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food: whole almonds
Food: non-nut snack
Sponsored by
Integrative Skin Science and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Collagen Degeneration

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Integrative Skin Science and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Almonds

Control Snack

Arm Description

Consumption of almonds 5 times per week

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

Outcomes

Primary Outcome Measures

Skin collagen and elastin quantification
Assess with biopsy based histological examination
Facial wrinkles
Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system)

Secondary Outcome Measures

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.
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.
Expression of enzymes that either degrade collagen (MMP1) or inhibit collagen degradation (TIMP1) on skin biopsies
Assess through biopsy based histological examination
Plasma for potential AGE (advanced glycation end products) analysis
Blood samples will be collected
Plasma for potential AGE (advanced glycation end products) analysis
Blood samples will be collected
Facial Wrinkles
Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system)

Full Information

First Posted
October 3, 2023
Last Updated
October 6, 2023
Sponsor
Integrative Skin Science and Research
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1. Study Identification

Unique Protocol Identification Number
NCT06074276
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integrative Skin Science and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Collagen Degeneration, Wrinkle, Pigmentation, Elastic Skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Almonds
Arm Type
Experimental
Arm Description
Consumption of almonds 5 times per week
Arm Title
Control Snack
Arm Type
Placebo Comparator
Arm Description
Consumption of protein and calorie matched non-nut-based food 5 times per week
Intervention Type
Other
Intervention Name(s)
Food: whole almonds
Intervention Description
60 grams or (~2 oz) will be consumed 5 times per week.
Intervention Type
Other
Intervention Name(s)
Food: non-nut snack
Intervention Description
Protein and calorie matched non-nut-based food will be consumed 5 times per week by mouth
Primary Outcome Measure Information:
Title
Skin collagen and elastin quantification
Description
Assess with biopsy based histological examination
Time Frame
24 weeks
Title
Facial wrinkles
Description
Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Pigment intensity score
Description
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.
Time Frame
12 Weeks
Title
Pigment intensity score
Description
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.
Time Frame
24 Weeks
Title
Expression of enzymes that either degrade collagen (MMP1) or inhibit collagen degradation (TIMP1) on skin biopsies
Description
Assess through biopsy based histological examination
Time Frame
24 Weeks
Title
Plasma for potential AGE (advanced glycation end products) analysis
Description
Blood samples will be collected
Time Frame
12 Weeks
Title
Plasma for potential AGE (advanced glycation end products) analysis
Description
Blood samples will be collected
Time Frame
24 Weeks
Title
Facial Wrinkles
Description
Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system)
Time Frame
12 Weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Adnan
Phone
9168074299
Email
sarah@integrativeskinresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD MS AP
Organizational Affiliation
Integrative Skin Science and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasima Afzal
Phone
916-750-2463
Email
nasima@integrativeskinresearch.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Almond on Facial Skin Collagen and Wrinkles

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