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

Body Composition Clinical Trial

— VEGOMNI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712590
• Other study ID #: VIST VEGOMNI 11-2022
• Status: Completed
• Start date: December 19, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2023
• Source: VIST - Faculty of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 31, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Composition
• Disease
• Skin Condition
• Skin Diseases

Intervention

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

Locations

Country	Name	City	State
Slovenia	VIST - Faculty of applied sciences, Institute of Cosmetics	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
VIST - Faculty of Applied Sciences

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermal density	It will be measured on forearm using ultrasonography as score 0-100.	baseline
Primary	Dermal thickness	It will be measured on forearm using ultrasonography in micrometeres.	baseline
Primary	Skin hydration	It will be measured on forearm using Cortex DermaLab flat hydration probe in microsiemens.	baseline
Primary	Skin elasticity	It will be measured on forearm using Cortex DermaLab elasticity probe in MPa.	baseline
Primary	Trans epidermal water loss	It will be measured on forearm using Cortex DermaLab open-chamberTEWL probe.	baseline
Primary	% of lean body weight	It will be measured using Multiscan is a spectroscopy (BIS).	baseline
Primary	% of body fat	It will be measured using Multiscan is a spectroscopy (BIS).	baseline