Collagen Peptides and Cellular Aging

Официальное название

Collagen Peptides and Cellular Aging: a Randomized, Placebo-controlled Intervention Study on Telomere Length, Inflammation, Body Composition, and Functional Capacity in Middle-aged and Older Adults

Обзор

The goal of this clinical trial is to learn if daily collagen peptide supplementation can stabilize or lengthen telomeres and improve related markers of cellular aging in adults aged 50-70 years with overweight and low-to-moderate physical activity (healthy volunteers without major chronic disease). Main questions it aims to answer are: Does six months of collagen peptides stabilize or extend telomere length and increase telomerase activity compared with placebo? Are any telomere-related changes associated with lower inflammation, healthier body composition, and better functional health? Researchers will compare collagen as an intervention to a placebo group to see if collagen will influence aging markers. Participants will take collagen peptides or a placebo daily for 24 weeks. They will attend three study visits: one before starting the intervention (T0), one at 3 months (T1), and one at 6 months (T2). At each visit, blood samples will be collected to measure telomere length, telomerase activity, and inflammation/redox markers. Participants will also undergo body composition assessments using bioelectrical impedance, complete functional tests of muscle strength and mobility, and fill out questionnaires on health and vitality.

Вмешательства

• Пищевая добавка Collagen peptides
  Collagen peptides (oral daily supplementation), taken once daily for 24 weeks in a randomized 1:1, double-blind design; primary outcomes: telomere length (qPCR T/S) and telomerase activity (TRAP), with inflammatory/redox markers as secondary endpoints. Target population: adults 50-70 years with BMI 25-30 and low-to-moderate activity; vegetarians/vegans excluded due to animal-derived collagen. Matched maltodextrin placebo, identical dosing and visit schedule (T0, T1, T2), serving as the compara
• Пищевая добавка Maltodextrin (Placebo)
  Placebo instead of the collagen peptides

Первичные конечные точки

• Telomere length [Срок оценки: Baseline and after supplementation (24 weeks)]
• Telomerase Activity [Срок оценки: Baseline and at the end of supplemention (24 weeks)]
• Change from baseline in DNA-oxidation markers [Срок оценки: Baseline and at the end of supplementation (24 weeks)]
• Change from baseline in micronuclei [Срок оценки: Baseline and at the end of supplementation (24 weeks)]

Вторичные конечные точки (12)

• Change from baseline in Inflammatory markers [Срок оценки: Baseline and at the end of supplemention (24 weeks)]
• Change from baseline in the redox/antioxidant status [Срок оценки: Baseline and at the end of supplementation (24 weeks)]
• Change from baseline in body composition [Срок оценки: Basline, after 3 months and at the end of the supplementation (24 weeks)]
• Change from baseline metabolic markers [Срок оценки: Baseline and at the end of supplementation (24 weeks)]
• Change from baseline in hormonal markers [Срок оценки: Baseline and at the end of supplementation (24 weeks)]
• Change from baseline in muscle strength [Срок оценки: Baseline, after 3 months and at the end of supplementation (24 weeks)]
• Change from baseline in dietary intake [Срок оценки: Baseline, after 3 months and at the end of supplementation (24 weeks)]
• Change from baseline in patient-reported outcomes like quality of life [Срок оценки: Baseline, after 3 months and at the end of supplementation (24 weeks)]
• Change of phase angle [Срок оценки: Basline, after 3 months and at the end of the supplementation (24 weeks)]
• Change from baseline in Insulin [Срок оценки: Baseline and at the end of supplementation (24 weeks)]
• Change from baseline in patient-reported outcomes like sleep quality [Срок оценки: Baseline, after 3 months and at the end of supplementation (24 weeks)]
• Change from baseline in patient-reported outcomes like health [Срок оценки: Baseline, after 3 months and at the end of supplementation (24 weeks)]

Критерии участия

Критерии включения

• Adults aged 50-70 years; both male and female participants are eligible
• Body mass index (BMI) 25-30 kg/m²
• Low to moderate physical activity: not meeting current WHO recommendations (<150 minutes/week) or ≤2 sessions/week structured training
• Able to live independently and mobile in daily life
• No regular resistance training within the past 6 months
• Provision of written informed consent

Критерии исключения

• Diagnosed chronic diseases relevant to the immune system, metabolism, or cellular aging (e.g., diabetes mellitus, cancer, cardiovascular, rheumatologic diseases)
• Use of immunomodulatory, systemic anti-inflammatory, or hormonal medications (e.g., corticosteroids, immunosuppressants)
• Acute infections or surgeries within the last 3 months
• Regular use of supplements known to affect oxidative stress or cellular aging (e.g., high-dose antioxidants, CoQ10, omega-3 fatty acids, high-dose vitamin D)
• Participation in another clinical study within the last 3 months
• Vegetarian or vegan diet (product contains animal-derived collagen)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Австрия · 1 центр

• University of Vienna, NuTraLab — Vienna

Идентификаторы

NCT: NCT07456449 · 01400 · Gelita-AG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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