Skin ConditionVEGOMNINCT05712590
The Influence of the Nutritional Status of Women Between 30 and 45 Years of Age on the Condition of the Skin and Body Composition
An observational study of Skin Condition and Body Composition, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Condition, Body Composition
- What is being tested?
- dietary habit
- How many people
- 48 participants
- Where
- 1 siteSlovenia
- Study dates
- 19 Dec 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women aged 30-45 years following vegan or vegetarian or omnivorous diet for at least 3 years.
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
VIST - Faculty of applied sciences, Institute of Cosmetics
Ljubljana, 1000
About this study
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.
Read the 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.
- Conditions
- Skin Condition, Body Composition
- Being tested
- dietary habit
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary habitOther
As it is observational study, women that follow three different dietary patterns will be inlcuded .
| Study group | Role | What they receive |
|---|---|---|
| Vegans | In this group women aged 30-45 years that follow vegan diet for at least 3 years will be included. Receives: 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. Receives: Other: dietary habit | |
| Omnivores | In this group women aged 30-45 years that follow omnivorous diet for at least 3 years will be included. Receives: Other: dietary habit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal density
It will be measured on forearm using ultrasonography as score 0-100.
Measured: baseline
Dermal thickness
It will be measured on forearm using ultrasonography in micrometeres.
Measured: baseline
Skin hydration
It will be measured on forearm using Cortex DermaLab flat hydration probe in microsiemens.
Measured: baseline
Skin elasticity
It will be measured on forearm using Cortex DermaLab elasticity probe in MPa.
Measured: baseline
Trans epidermal water loss
It will be measured on forearm using Cortex DermaLab open-chamberTEWL probe.
Measured: baseline
% of lean body weight
It will be measured using Multiscan is a spectroscopy (BIS).
Measured: baseline
% of body fat
It will be measured using Multiscan is a spectroscopy (BIS).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start19 Dec 2022
- Primary completion10 May 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIST - Faculty of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katja Žmitek, PhD, Study director, VIST Higher school of applied sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712590
- Sponsor's protocol ID
- VIST VEGOMNI 11-2022
- Acronym
- VEGOMNI
- Status last verified
- Apr 2023
- First submitted
- 7 Dec 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05712590
- Acronym / sponsor ID
- VEGOMNI / VIST VEGOMNI 11-2022
- Conditions
- Skin Condition, Body Composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- VIST - Faculty of Applied SciencesUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vegans | – | Other: dietary habitIn this group women aged 30-45 years that follow vegan diet for at least 3 years will be included. |
| Vegetarians | – | Other: dietary habitIn this group women aged 30-45 years that follow vegetarian (lacto-ovo/lacto/ovo) diet for at least 3 years will be included. |
| Omnivores | – | Other: dietary habitIn this group women aged 30-45 years that follow omnivorous diet for at least 3 years will be included. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women aged 30-45 years following vegan or vegetarian or omnivorous diet for at least 3 years.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary habitAs it is observational study, women that follow three different dietary patterns will be inlcuded . | Other | Omnivores, Vegans, Vegetarians |
Primary outcome
Dermal density
Time frame: baseline
It will be measured on forearm using ultrasonography as score 0-100.
Dermal thickness
Time frame: baseline
It will be measured on forearm using ultrasonography in micrometeres.
Skin hydration
Time frame: baseline
It will be measured on forearm using Cortex DermaLab flat hydration probe in microsiemens.
Skin elasticity
Time frame: baseline
It will be measured on forearm using Cortex DermaLab elasticity probe in MPa.
Trans epidermal water loss
Time frame: baseline
It will be measured on forearm using Cortex DermaLab open-chamberTEWL probe.
% of lean body weight
Time frame: baseline
It will be measured using Multiscan is a spectroscopy (BIS).
% of body fat
Time frame: baseline
It will be measured using Multiscan is a spectroscopy (BIS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Žmitek, PhD study director
VIST Higher school of applied sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Condition and Body Composition, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermal density (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.