NCT06074276

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

October 4, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

October 3, 2023

Last Update Submit

June 15, 2024

Conditions

Collagen DegenerationWrinklePigmentationElastic Skin

Outcome Measures

Primary Outcomes (2)

  • Skin collagen and elastin quantification

    Assess with biopsy based histological examination

    24 weeks

  • Facial wrinkles

    Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system). Higher scores indicate worsened wrinkle severity and lower scores represent improvement in wrinkle severity.

    24 weeks

Secondary Outcomes (6)

  • Pigment intensity score

    12 Weeks

  • Pigment intensity score

    24 Weeks

  • Expression of enzymes that either degrade collagen (MMP1) or inhibit collagen degradation (TIMP1) on skin biopsies

    24 Weeks

  • Plasma for potential AGE (advanced glycation end products) analysis

    12 Weeks

  • Plasma for potential AGE (advanced glycation end products) analysis

    24 Weeks

  • +1 more secondary outcomes

Study Arms (2)

Almonds

EXPERIMENTAL

Consumption of almonds 5 times per week

Other: Food: whole almonds

Control Snack

PLACEBO COMPARATOR

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

Other: Food: non-nut snack

Interventions

Food: whole almondsOTHER

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

Almonds
Food: non-nut snackOTHER

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

Control Snack

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects 35 to 70 years of age of all skin types
  • % of the subjects will be postmenopausal women determined as \>1-year loss of menstrual period
  • % 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95819, United States

RECRUITING

MeSH Terms

Conditions

Ehlers-Danlos Syndrome

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Raja Sivamani, MD MS AP

    Integrative Skin Science and Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Adnan

CONTACT

9168074299sarah@integrativeskinresearch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 10, 2023

Study Start

October 4, 2023

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)