The Effects of Almond on Facial Skin Collagen and Wrinkles

Sponsor
Integrative Skin Science and Research (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06074276
Collaborator
(none)
60
1
2
14.9
4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Food: whole almonds
  • Other: Food: non-nut snack
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Controlled Trial on the Effects of Almond on Facial Skin Collagen and Wrinkles
Actual Study Start Date :
Oct 4, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Skin collagen and elastin quantification [24 weeks]

    Assess with biopsy based histological examination

  2. Facial wrinkles [24 weeks]

    Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system)

Secondary Outcome Measures

  1. Pigment intensity score [12 Weeks]

    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.

  2. Pigment intensity score [24 Weeks]

    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.

  3. Expression of enzymes that either degrade collagen (MMP1) or inhibit collagen degradation (TIMP1) on skin biopsies [24 Weeks]

    Assess through biopsy based histological examination

  4. Plasma for potential AGE (advanced glycation end products) analysis [12 Weeks]

    Blood samples will be collected

  5. Plasma for potential AGE (advanced glycation end products) analysis [24 Weeks]

    Blood samples will be collected

  6. Facial Wrinkles [12 Weeks]

    Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system)

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Integrative Skin Science and Research Sacramento California United States 95819

Sponsors and Collaborators

  • Integrative Skin Science and Research

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Integrative Skin Science and Research
ClinicalTrials.gov Identifier:
NCT06074276
Other Study ID Numbers:
  • i23-07_Almond_Collagen
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2023