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RecruitingNCT07345195TO-COSKIN4Updated Nov 10, 2026

The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Facial Erythema and Other Skin Parameters

An interventional study of CPMSM-HD and CPMSM-LD in Erythema, Telangiectasis and Skin Redness, sponsored by VIST - Faculty of Applied Sciences. Recruiting at 1 site in Slovenia. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by VIST - Faculty of Applied Sciences · Not applicable, Interventional, and Treatment

Updated Nov 10, 2026Now RecruitingSite recruiting status changed+7 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
Female
01

Study summary

The aim of this study is to compare the effects of 16 weeks of daily dietary supplementation with two investigational products containing collagen, methylsulfonylmethane (MSM), and vitamin C on skin parameters in comparison to a placebo product. The study will be conducted in healthy women aged 40 to 65 years with visible facial erythema and telangiectasiae (cheeks), stable for ≥3 months, without active rosacea. The primary objective is to demonstrate beneficial effects of the investigational products on facial erythema. The secondary objectives are to evaluate the effect on facial erythema after 8 weeks and the effects on telangiectasiae severity and other redness-related skin parameters. Other skin parameters will be assessed as supportive endpoints, and differences between the two investigational formulations will also be explored.

Read the detailed description

This is a single-centre, randomized, double-blind, placebo-controlled, one-period effectiveness study designed to evaluate the effects of multiple-dose, daily dietary supplementation over a 16-week period on skin parameters in healthy women aged 40 to 65 years. The study population consists of subjects with visible facial erythema and telangiectasiae predominantly on the cheeks, stable for at least 3 months prior to inclusion, and without clinical signs of active rosacea.

Eligible participants will be randomized to receive one of two investigational products or a placebo product, administered as a daily oral dose of 30 mL for 16 consecutive weeks. The investigational products contain the following compositions: Investigational Product 1 (IP1): collagen 10 g, methylsulfonylmethane (MSM) 2.0 g, and vitamin C 160 mg; and Investigational Product 2 (IP2): collagen 5 g, MSM 1.5 g, and vitamin C 160 mg.

The primary objective of the study is to evaluate whether 16 weeks of supplementation with the investigational products results in a beneficial effect on facial erythema compared with placebo. The secondary objectives are to assess the effect on facial erythema after 8 weeks and the effects on telangiectasiae severity and other redness-related skin parameters. Supportive objectives include the evaluation of additional skin parameters; differences between the two investigational formulations will also be explored.

All participants also take part in a nested substudy (Part B), registered separately, assessing advanced glycation end products in the skin.

02

Conditions studied

  • Erythema
  • Telangiectasis
  • Skin Redness

Keywords

  • Facial telangiectasiae
  • Erythema
  • Facial erythema
  • Collagen
  • MSM
  • Dietary supplement
  • Skin health
  • Skin redness
  • Erythema-prone skin
03

In context

Erythema

131 studies on the registry are indexed under Erythema; 17 are open to participants now.

This study's planned enrollment of 90 is above the median of 50 across 114 interventional studies indexed under Erythema.

Browse Erythema studies →

Lead sponsor

VIST - Faculty of Applied Sciences is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 28, 2026. See what changed

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Caucasian female volunteers aged 40 to 65 years at the time of signing the Form (ICF).
  • Signed ICF.
  • Fitzpatrick skin phototypes I-IV.
  • Presence of visible facial telangiectasias, primarily on the cheeks.
  • Presence of facial erythema with a baseline score \<= 3 on the 5-point Clinician's Erythema Assessment (CEA) scale.
  • Stable erythema-prone facial skin for at least 3 months prior to inclusion, without clinical signs of active rosacea.
  • In good general health, as determined by medical history.
  • (BMI) \< 35.
  • Willingness and ability to comply with all study procedures and complete a subject diary; maintain usual lifestyle habits; not initiate or modify oestrogen or progesterone therapies; maintain the same cosmetic and skincare routine and comply with sun protection guidelines; avoid rejuvenation treatments; refrain from food supplements containing collagen or other protein-based supplements, MSM, or anti-inflammatory and/or antioxidant compounds with a known or potential impact on skin inflammation or vascular response; and refrain from shaving, waxing, epilating or otherwise removing hair from the forearms for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Vegan diet.
  • Following a weight-loss diet or another special or restrictive diet (e.g. very-low-calorie, ketogenic or intermittent fasting), or planning to start one during the study.
  • Heavy smoking (more than 20 cigarettes per day) or frequent alcohol-induced flushing.
  • Occupational or hobby-related excessive heat exposure (e.g. chefs, sauna workers).
  • Anticipated sunbathing or solarium use, or major planned changes in sun exposure before or during the study.
  • Planned major changes during the study in skincare routine or hormonal therapy ( or hormone replacement therapy).
  • Significant changes in dietary habits or dietary supplementation within 3 months prior to inclusion.
  • Regular use within 3 months prior to inclusion of food supplements containing MSM, collagen or other protein-based supplements, or anti-inflammatory (e.g. bioflavonoids/rutin, curcumin, EPA) and/or antioxidant supplements with a known or potential impact on skin inflammation or vascular response.
  • Any diagnosed, uncontrolled, untreated or unstable medical condition.
  • history of metabolic, gastrointestinal, hepatic, renal or haematological disease.
  • Diagnosed diabetes mellitus (type 1 or type 2), or current use of glucose-lowering medication.
  • Current use, or use within 12 months prior to study entry, of medicines for weight reduction, including GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists, or planned use during the study.
  • Mental incapacity or psychiatric condition that may impair understanding of the study or compliance with study requirements.
  • Any clinically significant acute or chronic inflammatory skin disease (e.g. acne, perioral dermatitis, psoriasis, atopic dermatitis, lupus).
  • Skin pigmentation disorders at the assessment sites.
  • Active rosacea within 3 months prior to study entry (papules/pustules, frequent flushing episodes typical of rosacea, or ocular involvement).
  • Frequent vasomotor hot flushes (e.g. perimenopausal or menopausal).
  • Use of medications affecting skin or vascular reactivity (e.g. systemic , anticoagulants, vasodilators, antibiotics known to affect vascular response, immunomodulators, regular or long-term use of NSAIDs).
  • Use of systemic retinoids within 3 months prior to study entry.
  • Changes of skincare routine within 4 weeks prior to study entry.
  • Use of highly concentrated topical products affecting inflammatory or vascular facial responses (e.g. >15% azelaic acid, 10% vitamin C) within 4 weeks prior to study entry.
  • Invasive rejuvenation treatments (e.g. medium or deep chemical peels, ablative or vascular laser therapies) within 6 months prior to study entry.
  • Non-invasive or minimally invasive rejuvenation treatments (e.g. microneedling, mesotherapy, superficial chemical peels, radiofrequency, electrotherapy, ultrasound, IPL) within 3 months prior to study entry.
  • Tattoos, scars, birthmarks, pronounced hyperpigmentation, visible vessels, or an active skin lesion or skin disease at the volar forearm of both forearms.
  • Self-tanning products applied to the forearms, or deliberate UV exposure of the forearms (sunbathing, solarium), within 4 weeks before the first visit.
  • Known or suspected allergy to any ingredient of the products.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    IP1 group

    Participants will receive investigational product 1 containing collagen (10 g/ 30 mL), MSM (2.0 g/ 30 mL) and vitamin C (160 mg/ 30 mL) for 16 weeks.

    Dietary Supplement: CPMSM-HD

  • Active comparator
    IP2 group

    Participants will receive investigational product 2 containing collagen (5 g/ 30 mL), MSM (1.5 g/ 30 mL) and vitamin C (160 mg/ 30 mL) for 16 weeks.

    Dietary Supplement: CPMSM-LD

  • Placebo comparator
    Placebo group

    Placebo group participants will receive placebo syrup without active ingredients (0 mg of collagen, 0 mg of MSM and 0 mg of vitamin C), 30 mL/daily for 16 weeks.

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementCPMSM-HD

    Participants will test continuous administration of investigational product for 16 weeks.

    Also known as: Investigational product 1

  • Dietary supplementCPMSM-LD

    Participants will test continuous administration of the investigational product for 16 weeks.

    Also known as: Investigational product 2

  • Dietary supplementPlacebo

    Participants will test continuous administration of placebo product for 16 weeks.

06

What researchers measure

Primary outcomes

  1. Change in facial erythema (redness - average) from baseline to week 16

    Redness - average in arbitrary units (a.u.), Antera 3D CS multispectral imaging; each investigational product compared with placebo.

    Time frame: From baseline to end of intervention at 16 weeks

Secondary outcomes

  1. Change in haemoglobin hyper-concentration from baseline to week 16

    Haemoglobin hyper-concentration (a.u.), Antera 3D CS, as a measure of facial telangiectasiae severity; each investigational product compared with placebo; also assessed at week 8.

    Time frame: From baseline to end of intervention at 16 weeks

  2. Change in redness - variation from baseline to week 16

    Redness - variation (a.u.), Antera 3D CS, as a measure of the variability (unevenness) of facial redness; also assessed at week 8.

    Time frame: From baseline to end of intervention at 16 weeks

  3. Change in skin colour (delta a*) from baseline to week 16

    Delta a\* (CIELAB red-green axis), Antera 3D CS

    Time frame: From baseline to end of intervention at 16 weeks

Other outcomes

  1. Change in dermis density from baseline to week 16

    Dermis intensity (0-100), 20 MHz ultrasonography (Cortex DermaLab), volar forearm

    Time frame: From baseline to end of intervention at 16 weeks

  2. Change in dermis thickness from baseline to week 16

    Dermis thickness (µm), 20 MHz ultrasonography (Cortex DermaLab), volar forearm;

    Time frame: From baseline to end of intervention at 16 weeks

  3. Change in skin elasticity (R2) from baseline to week 16

    Skin elasticity parameter R2, volar forearm measured with Cortex DermaLab

    Time frame: From baseline to end of intervention at 16 weeks

07

Study locations

1 of 1 sites recruiting
  • VIST - Faculty of Applied Sciences, Institute of Cosmetics
    Ljubljana, Ljubljana 1000, Slovenia
    Recruiting
    • Katja Zmitek, PhD · Contactkatja.zmitek@vist.si · 002831700
    • Katja Žmitek, PhD · Principal investigator
    • Tina Pogačnik, MSc · Sub investigator
    • Petra Keršmanc, MSc · Sub investigator
    • Sara Jereb, MSc · Sub investigator
    • Manica Bevec, BSc · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.

Of 23 non-industry interventional studies with no phase under Erythema, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's planned 7 months is below that.

Counting every sponsor, half of 43 studies reached it within 3 months; a quarter within 1 and three quarters within 11.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 28, 2026: start Jan 2026 → Nov 2026, primary completion Sep 2026 → Jun 2027 and completion Nov 2026 → Oct 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 24, 2025
First posted
Jan 15, 2026
StartEst.
Nov 16, 2026was Jan 2026
Primary completionEst.
Jun 30, 2027was Sep 2026
CompletionEst.
Oct 2027was Nov 2026
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 10, 2026
Sites
1 site added, 1 site removed. VIST - Faculty of Applied Sciences, Institute of Cosmetics is now Recruiting
Show site
  • VIST - Faculty of Applied Sciences, Institute of Cosmetics · Ljubljana, Slovenia
Show 1 removed
  • VIST - Faculty of Applied Sciences, Institute of Cosmetics · Ljubljana, Slovenia
across 2 updates, Oct 28, 2026 – Nov 10, 2026
Start date
Jan 2026→Nov 16, 2026
Oct 28, 2026
Primary completion
Sep 2026→Jun 30, 2027
Oct 28, 2026
Study completion
Nov 2026→Oct 2027
Oct 28, 2026
Eligibility
Minimum age 35 Years→40 Years; 5 inclusion criteria edited, 7 removed; 13 exclusion criteria edited, 5 added, 5 removed
What changed in the criteria
Inclusion criteria
  • EditedCaucasian female volunteers aged 3540 to 65 years at the time of signing the Informed Consent Form (ICF).
  • EditedSigned Informed Consent Form (ICF).
  • RemovedPresence of visible signs of skin ageing.
  • EditedPresence of facial erythema with a baseline score ≤<= 3 on the 5-point ClinicalClinician's Erythema Assessment (CEA) scale.
  • EditedStable erythema-prone facial skin for at least 3 months prior to study inclusion, without clinical signs of active rosacea.
  • RemovedWillingness and ability to:
  • RemovedComply with all study procedures and complete a subject diary.
  • RemovedMaintain usual lifestyle habits throughout the study.
  • RemovedNot initiate or modify oestrogen or progesterone therapies during the study.
  • RemovedMaintain the same cosmetic and skincare routine and comply with sun protection guidelines throughout the study.
  • RemovedAvoid rejuvenation treatments during the study.
  • EditedRefrainWillingness and ability to comply with all study procedures and complete a subject diary; maintain usual lifestyle habits; not initiate or modify oestrogen or progesterone therapies; maintain the same cosmetic and skincare routine and comply with sun protection guidelines; avoid rejuvenation treatments; refrain from consuming food supplements containing collagen or other protein-based supplements, methylsulfonylmethane (MSM), or anti-inflammatory and/or antioxidant compounds with a known or potential impact on skin inflammation or vascular response; and refrain from shaving, waxing, epilating or otherwise removing hair from the forearms for the duration of the study.
Exclusion criteria
  • AddedFollowing a weight-loss diet or another special or restrictive diet (e.g. very-low-calorie, ketogenic or intermittent fasting), or planning to start one during the study.
  • EditedHeavy smoking (more than 20 cigarettes per day) or frequent alcohol-induced flushing.
  • EditedOccupational or hobby-related excessive heat exposure (e.g. chefs, sauna workers) likely to interfere with vascular stability.
  • RemovedPlanned major changes during the study in:
  • RemovedSkincare routine
  • EditedHormonalPlanned major changes during the study in skincare routine or hormonal therapy (contraception or hormone replacement therapy).
  • RemovedRegular use within 3 months prior to inclusion of food supplements containing:
  • RemovedMethylsulfonylmethane (MSM);
  • RemovedCollagen or other protein-based supplements;
  • EditedAntiRegular use within 3 months prior to inclusion of food supplements containing MSM, collagen or other protein-based supplements, or anti-inflammatory supplements (e.g. bioflavonoids/rutin, curcumin, EPA) and/or antioxidant supplements with a known or potential impact on skin inflammation or vascular response.
  • EditedAny diagnosed, uncontrolled, untreated, or unstable medical condition.
  • EditedClinically significant history of metabolic, gastrointestinal, hepatic, renal, or haematological disease.
  • AddedDiagnosed diabetes mellitus (type 1 or type 2), or current use of glucose-lowering medication.
  • AddedCurrent use, or use within 12 months prior to study entry, of medicines for weight reduction, including GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists, or planned use during the study.
  • EditedAny clinically significant acute or chronic inflammatory skin disease, including but not limited to (e.g. acne, perioral dermatitis, psoriasis, atopic dermatitis, or lupus).
  • EditedActive rosacea within 3 months prior to study entry, defined as the presence of (papules/pustules, frequent flushing episodes typical of rosacea, or ocular involvement).
  • EditedFrequent vasomotor hot flushes (e.g. perimenopausal or menopausal), which may interfere with erythema assessments.
  • EditedUse of medications affecting skin or vascular reactivity, including but not limited to: (e.g. systemic corticosteroids, anticoagulants (e.g. coumarins, heparin), vasodilators (e.g. hydralazine, nitroglycerin), antibiotics with potentialknown to affect erythema or vascular response, immunomodulators, regular or long-term use of non-steroidal anti-inflammatory drugs (NSAIDs).
  • EditedChanges of skin careskincare routine regimen within 4 weeks prior to study entry.
  • EditedUse of highly concentrated topical products affecting inflammatory or vascular facial responses (e.g. >15% azelaic acid, 10% vitamin C…) affecting inflammatory or vascular facial responses within 4 weeks prior to study entry.
  • AddedTattoos, scars, birthmarks, pronounced hyperpigmentation, visible vessels, or an active skin lesion or skin disease at the volar forearm of both forearms.
  • AddedSelf-tanning products applied to the forearms, or deliberate UV exposure of the forearms (sunbathing, solarium), within 4 weeks before the first visit.
  • EditedKnown or suspected allergy to any ingredient of the investigational product(s)products.
Oct 28, 2026
Primary outcomes
1 added, 4 removed
What changed in the outcomes
  • AddedChange in facial erythema (redness - average) from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
  • RemovedChange of redness score from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementationTime frame: 16 weeks
  • RemovedChange of redness variation from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementationTime frame: 16 weeks
  • RemovedChange of hemoglobin hyperconcentration area from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementationTime frame: 16 weeks
  • RemovedChange of hemoglobin hyperconcentration intensity from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementationTime frame: 16 weeks
Oct 28, 2026
Secondary outcomes
6 added, 1 removed
What changed in the outcomes
  • AddedChange in haemoglobin hyper-concentration from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
  • AddedChange in redness - variation from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
  • AddedChange in skin colour (delta a*) from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
  • RemovedChange of visibility of facial telenagiectasiae from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementationTime frame: 16 weeks
  • Addedother outcomeChange in dermis density from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
  • Addedother outcomeChange in dermis thickness from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
  • Addedother outcomeChange in skin elasticity (R2) from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
Oct 28, 2026
Show all 2 updates
  1. Nov 10, 2026
    Not yet recruiting→Recruiting
    VIST - Faculty of Applied Sciences, Institute of Cosmetics is now Recruiting
    + 1 other change: verification date
  2. Oct 28, 2026
    1 site added, 1 site removed
    Show site
    • VIST - Faculty of Applied Sciences, Institute of Cosmetics · Ljubljana, Slovenia
    Show 1 removed
    • VIST - Faculty of Applied Sciences, Institute of Cosmetics · Ljubljana, Slovenia
    Start date Jan 2026→Nov 16, 2026
    Primary completion Sep 2026→Jun 30, 2027
    Study completion Nov 2026→Oct 2027
    Eligibility Minimum age 35 Years→40 Years; 5 inclusion criteria edited, 7 removed; 13 exclusion criteria edited, 5 added, 5 removed
    What changed in the criteria
    Inclusion criteria
    • EditedCaucasian female volunteers aged 3540 to 65 years at the time of signing the Informed Consent Form (ICF).
    • EditedSigned Informed Consent Form (ICF).
    • RemovedPresence of visible signs of skin ageing.
    • EditedPresence of facial erythema with a baseline score ≤<= 3 on the 5-point ClinicalClinician's Erythema Assessment (CEA) scale.
    • EditedStable erythema-prone facial skin for at least 3 months prior to study inclusion, without clinical signs of active rosacea.
    • RemovedWillingness and ability to:
    • RemovedComply with all study procedures and complete a subject diary.
    • RemovedMaintain usual lifestyle habits throughout the study.
    • RemovedNot initiate or modify oestrogen or progesterone therapies during the study.
    • RemovedMaintain the same cosmetic and skincare routine and comply with sun protection guidelines throughout the study.
    • RemovedAvoid rejuvenation treatments during the study.
    • EditedRefrainWillingness and ability to comply with all study procedures and complete a subject diary; maintain usual lifestyle habits; not initiate or modify oestrogen or progesterone therapies; maintain the same cosmetic and skincare routine and comply with sun protection guidelines; avoid rejuvenation treatments; refrain from consuming food supplements containing collagen or other protein-based supplements, methylsulfonylmethane (MSM), or anti-inflammatory and/or antioxidant compounds with a known or potential impact on skin inflammation or vascular response; and refrain from shaving, waxing, epilating or otherwise removing hair from the forearms for the duration of the study.
    Exclusion criteria
    • AddedFollowing a weight-loss diet or another special or restrictive diet (e.g. very-low-calorie, ketogenic or intermittent fasting), or planning to start one during the study.
    • EditedHeavy smoking (more than 20 cigarettes per day) or frequent alcohol-induced flushing.
    • EditedOccupational or hobby-related excessive heat exposure (e.g. chefs, sauna workers) likely to interfere with vascular stability.
    • RemovedPlanned major changes during the study in:
    • RemovedSkincare routine
    • EditedHormonalPlanned major changes during the study in skincare routine or hormonal therapy (contraception or hormone replacement therapy).
    • RemovedRegular use within 3 months prior to inclusion of food supplements containing:
    • RemovedMethylsulfonylmethane (MSM);
    • RemovedCollagen or other protein-based supplements;
    • EditedAntiRegular use within 3 months prior to inclusion of food supplements containing MSM, collagen or other protein-based supplements, or anti-inflammatory supplements (e.g. bioflavonoids/rutin, curcumin, EPA) and/or antioxidant supplements with a known or potential impact on skin inflammation or vascular response.
    • EditedAny diagnosed, uncontrolled, untreated, or unstable medical condition.
    • EditedClinically significant history of metabolic, gastrointestinal, hepatic, renal, or haematological disease.
    • AddedDiagnosed diabetes mellitus (type 1 or type 2), or current use of glucose-lowering medication.
    • AddedCurrent use, or use within 12 months prior to study entry, of medicines for weight reduction, including GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists, or planned use during the study.
    • EditedAny clinically significant acute or chronic inflammatory skin disease, including but not limited to (e.g. acne, perioral dermatitis, psoriasis, atopic dermatitis, or lupus).
    • EditedActive rosacea within 3 months prior to study entry, defined as the presence of (papules/pustules, frequent flushing episodes typical of rosacea, or ocular involvement).
    • EditedFrequent vasomotor hot flushes (e.g. perimenopausal or menopausal), which may interfere with erythema assessments.
    • EditedUse of medications affecting skin or vascular reactivity, including but not limited to: (e.g. systemic corticosteroids, anticoagulants (e.g. coumarins, heparin), vasodilators (e.g. hydralazine, nitroglycerin), antibiotics with potentialknown to affect erythema or vascular response, immunomodulators, regular or long-term use of non-steroidal anti-inflammatory drugs (NSAIDs).
    • EditedChanges of skin careskincare routine regimen within 4 weeks prior to study entry.
    • EditedUse of highly concentrated topical products affecting inflammatory or vascular facial responses (e.g. >15% azelaic acid, 10% vitamin C…) affecting inflammatory or vascular facial responses within 4 weeks prior to study entry.
    • AddedTattoos, scars, birthmarks, pronounced hyperpigmentation, visible vessels, or an active skin lesion or skin disease at the volar forearm of both forearms.
    • AddedSelf-tanning products applied to the forearms, or deliberate UV exposure of the forearms (sunbathing, solarium), within 4 weeks before the first visit.
    • EditedKnown or suspected allergy to any ingredient of the investigational product(s)products.
    Primary outcomes 1 added, 4 removed
    What changed in the outcomes
    • AddedChange in facial erythema (redness - average) from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
    • RemovedChange of redness score from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementationTime frame: 16 weeks
    • RemovedChange of redness variation from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementationTime frame: 16 weeks
    • RemovedChange of hemoglobin hyperconcentration area from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementationTime frame: 16 weeks
    • RemovedChange of hemoglobin hyperconcentration intensity from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementationTime frame: 16 weeks
    Secondary outcomes 6 added, 1 removed
    What changed in the outcomes
    • AddedChange in haemoglobin hyper-concentration from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
    • AddedChange in redness - variation from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
    • AddedChange in skin colour (delta a*) from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
    • RemovedChange of visibility of facial telenagiectasiae from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementationTime frame: 16 weeks
    • Addedother outcomeChange in dermis density from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
    • Addedother outcomeChange in dermis thickness from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
    • Addedother outcomeChange in skin elasticity (R2) from baseline to week 16Time frame: From baseline to end of intervention at 16 weeks
    + 2 other changes: verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07345195
Lead sponsor
VIST - Faculty of Applied Sciences
Collaborators
Tosla d.o.o., Slovenian Research Agency
Responsible party
Sponsor
First posted
Jan 15, 2026
Start date
Nov 16, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Katja Žmitek, PhD
Contact
katja.zmitek@vist.si
0038612831700
Janko Žmitek, PhD
Contact
kozmetika@vist.si
0038612831700
Katja Žmitek, PhD
study director · Head of Reasearch Group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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