Effect of Collagen and MSM Supplementation on Advanced Glycation End Products in Skin: Part B of the TO-COSKIN4 Study (TO-COSKIN4-B)
The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Advanced Glycation End Products in Skin
This nested substudy (Part B) of the VIST TO-COSKIN4 study (NCT07345195) evaluates whether 16 weeks of daily dietary supplementation with two investigational products containing collagen, methylsulfonylmethane (MSM) and vitamin C affects advanced glycation end products (AGEs) in the skin, compared with placebo. AGEs are compounds formed when sugars bind to proteins such as collagen, and they accumulate in the skin with age. They are assessed non-invasively by skin autofluorescence on the forearm. Part B includes the same participants (healthy women aged 40 to 65 years), randomisation and visits as the main study. The primary objective is to evaluate the effect of each investigational product, compared with placebo, on skin autofluorescence after 16 weeks; the secondary objective is to evaluate the effect after 8 weeks.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Part B is a nested substudy conducted in all participants of the VIST TO-COSKIN4 study (NCT07345195), a single-centre, randomised, double-blind, placebo-controlled, three-arm parallel-group study. Participants are allocated by the randomisation of the main study to one of two investigational products containing collagen, MSM and vitamin C, or to placebo, taken orally as 30 mL of syrup once daily for 16 weeks. Part B is described in a separate protocol annex and is analysed and reported separately from the main study.
Advanced glycation end products in the skin are assessed by skin autofluorescence, measured non-invasively with the AGE Reader on the volar forearm at baseline, week 8 and week 16. The primary endpoint is the change in skin autofluorescence from baseline to week 16, and the secondary endpoint is the change from baseline to week 8. Each investigational product is compared with placebo.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前:Katja Žmitek, PhD
- 電話番号:+386 1 283 1700
- メール:katja.zmitek@vist.si
研究連絡先のバックアップ
- 名前:Janko Žmitek, PhD
- 電話番号:+386 1 283 1700
- メール:kozmetika@vist.si
研究場所
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Ljubljana、スロベニア、1000
- VIST - Faculty of Applied Sciences, Institute of Cosmetics
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主任研究者:
- Katja Žmitek, PhD
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副調査官:
- Tina Pogačnik, MSc
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副調査官:
- Petra Keršmanc, MSc
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副調査官:
- Manica Bevec, BSc
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コンタクト:
- Katja Žmitek, PhD
- 電話番号:+386 1 283 1700
- メール:katja.zmitek@vist.si
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Caucasian female volunteers aged 40 to 65 years at the time of signing the Informed Consent 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 of 3 or less 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.
- Body mass index (BMI) below 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:
- 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 (contraception 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.
- Clinically significant 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 corticosteroids, 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. more than 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 investigational products.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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アクティブコンパレータ: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. |
Participants will test continuous administration of investigational product for 16 weeks.
他の名前:
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アクティブコンパレータ: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. |
Participants will test continuous administration of the investigational product for 16 weeks.
他の名前:
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プラセボコンパレーター: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. |
Participants will test continuous administration of placebo product for 16 weeks. |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in skin autofluorescence from baseline to week 16
時間枠:Baseline and week 16
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Skin autofluorescence in arbitrary units (AU), measured with the AGE Reader on the volar surface of the dominant forearm; mean of two triple measurements per visit; each investigational product compared with placebo. |
Baseline and week 16
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in skin autofluorescence from baseline to week 8
時間枠:Baseline and week 8
|
Skin autofluorescence in arbitrary units (AU), measured with the AGE Reader on the volar surface of the dominant forearm; mean of two triple measurements per visit; each investigational product compared with placebo. |
Baseline and week 8
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者:Katja Žmitek, PhD、VIST - Faculty of Applied Sciences
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- VIST TO-COSKIN4, Part B
- Annex B to VIST TO-COSKIN4 (その他の識別子:VIST - Faculty of Applied Sciences)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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