VEGOMNI: The Influence of the Nutritional Status of Women Between 30 and 45 Years of Age on the Condition of the Skin and Body Composition

Sponsor
VIST - Faculty of Applied Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05712590
Collaborator
(none)
60
1
5.3
11.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: dietary habit

Detailed Description

Investigators will investigate differences among female subjects aged 30-45 years following one of the following diet for at least 3 years:

  • vegan

  • vegetarian

  • omnivorous

Study will focus into the differences in dermal protein density and dermal thickness, skin hydration and trans-epidermal water loss. Study will focus also into body composition, specifically into % of body fat and % of lean body weight.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
The Influence of the Nutritional Status of Women Between 30 and 45 Years of Age on the Condition of the Skin and Body Composition
Anticipated Study Start Date :
Feb 20, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Vegans

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

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

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

Omnivores

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

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

Outcome Measures

Primary Outcome Measures

  1. Dermal density [baseline]

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

  2. Dermal thickness [baseline]

    It will be measured on forearm using ultrasonography in micrometeres.

  3. Skin hydration [baseline]

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

  4. Skin elasticity [baseline]

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

  5. Trans epidermal water loss [baseline]

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

  6. % of lean body weight [baseline]

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

  7. % of body fat [baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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,

  • pacemaker.

Contacts and Locations

Locations

Site City State Country Postal Code
1 VIST - Faculty of applied sciences, Institute of Cosmetics Ljubljana Slovenia 1000

Sponsors and Collaborators

  • VIST - Faculty of Applied Sciences

Investigators

  • Study Director: Katja Žmitek, PhD, VIST Higher school of applied sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VIST - Faculty of Applied Sciences
ClinicalTrials.gov Identifier:
NCT05712590
Other Study ID Numbers:
  • VIST VEGOMNI 11-2022
First Posted:
Feb 3, 2023
Last Update Posted:
Feb 3, 2023
Last Verified:
Jan 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 Feb 3, 2023