NCT05712590

Brief Summary

Goal is to investigate the differences in skin condition and body composition among women with different dietary habits aged 30-45 years. Study will be focused onto sub-groups of female subjects following omnivorous, vegetarian or vegan diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

December 19, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

January 8, 2024

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

December 7, 2022

Last Update Submit

January 5, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Dermal density

    It will be measured on forearm using ultrasonography as score 0-100.

    baseline

  • Dermal thickness

    It will be measured on forearm using ultrasonography in micrometeres.

    baseline

  • Skin hydration

    It will be measured on forearm using Cortex DermaLab flat hydration probe in microsiemens.

    baseline

  • Skin elasticity

    It will be measured on forearm using Cortex DermaLab elasticity probe in MPa.

    baseline

  • Trans epidermal water loss

    It will be measured on forearm using Cortex DermaLab open-chamberTEWL probe.

    baseline

  • % of lean body weight

    It will be measured using Multiscan is a spectroscopy (BIS).

    baseline

  • % of body fat

    It will be measured using Multiscan is a spectroscopy (BIS).

    baseline

Study Arms (3)

Vegans

In this group women aged 30-45 years that follow vegan diet for at least 3 years will be included.

Other: dietary habit

Vegetarians

In this group women aged 30-45 years that follow vegetarian (lacto-ovo/lacto/ovo) diet for at least 3 years will be included.

Other: dietary habit

Omnivores

In this group women aged 30-45 years that follow omnivorous diet for at least 3 years will be included.

Other: dietary habit

Interventions

As it is observational study, women that follow three different dietary patterns will be inlcuded .

OmnivoresVegansVegetarians

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy women aged 30-45 years following vegan or vegetarian or omnivorous diet for at least 3 years.

You may qualify if:

  • women
  • aged 30-45 years
  • vegan or vegetarian or omnivorous diet for at least 3 years,
  • body mass index (BMI) between 18.5 and 25.

You may not qualify if:

  • smoking or have smoked in the past (quit less than 3 years ago),
  • pregnancy or breastfeeding,
  • pre-menopause
  • medications that increase skin dryness (e.g. retinoids),
  • visiting solariums,
  • visiting of the fitness center more than 3 times a week,
  • regular consumption of protein supplements (including food supplements with collagen),
  • chronic and acute skin diseases,
  • chronic and acute diseases of the gastrointestinal tract (e.g. celiac disease),
  • lactose intolerance,
  • various diets (e.g. health, slimming),
  • damaged skin in the test area (inner forearm),
  • hyperhidrosis or increased sweating,
  • diseases that cause a chronically damaged skin barrier (e.g. atopic dermatitis, ichthyosis),
  • cancer diseases,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIST - Faculty of applied sciences, Institute of Cosmetics

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Katja Žmitek, PhD

    VIST Higher school of applied sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

February 3, 2023

Study Start

December 19, 2022

Primary Completion

May 10, 2023

Study Completion

August 31, 2023

Last Updated

January 8, 2024

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations