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

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.

Study Overview

• Status: Completed
• Conditions: Body Composition; Skin Condition
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

• Study Contact: Name: Katja Zmitek, PhD; Phone Number: 012831700; Email: katja.zmitek@vist.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • VIST - Faculty of Applied Sciences, Institute of Cosmetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VIST - Faculty of Applied Sciences
• Investigators: Study Director: Katja Žmitek, PhD, VIST Higher school of applied sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Skin Diseases
• Other Study ID Numbers: VIST VEGOMNI 11-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No