Recruiting

Almond

Sponsor:

Integrative Skin Science and Research

Code:

NCT06074276

Conditions

Collagen Degeneration

Wrinkle

Pigmentation

Elastic Skin

Eligibility Criteria

Sex: Female

Age: 35 - 70

Healthy Volunteers: Accepted

Interventions

Food: whole almonds

Food: non-nut snack

Study Details

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.

Conditions

Collagen Degeneration

Wrinkle

Pigmentation

Elastic Skin

Study ID

NCT06074276

Start date

Oct 4, 2023

Status verified date

Jun, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Food: whole almonds

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

Food: non-nut snack

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

Primary outcome measure

  • Skin collagen and elastin quantification [ Time Frame: 24 weeks ]
  • Facial wrinkles [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Sarah Adnan

9168074299sarah@integrativeskinresearch.com

Locations

Integrative Skin Science and Research

Recruiting

Sacramento, California, United States, 95819

Contacts

Nasima Afzal

916-750-2463nasima@integrativeskinresearch.com

More Information

Sponsor

Integrative Skin Science and Research

Last update posted

Jun 18, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Integrative Skin Science and Research on 2024-06-18.