The Effects of Almond on Facial Skin Collagen and Wrinkles

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 35 Years - 70 Years
Gender Female
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06074276
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Integrative Skin Science and Research
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Raja Sivamani, MD MS AP
Principal Investigator Affiliation Integrative Skin Science and Research
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Collagen Degeneration, Wrinkle, Pigmentation, Elastic Skin
Additional Details

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.

Arms & Interventions

Arms

Experimental: Almonds

Consumption of almonds 5 times per week

Placebo Comparator: Control Snack

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

Interventions

Other: - Food: whole almonds

60 grams or (~2 oz) will be consumed 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Integrative Skin Science and Research, Sacramento, California

Status

Recruiting

Address

Integrative Skin Science and Research

Sacramento, California, 95819

Site Contact

Nasima Afzal

[email protected]

916-750-2463