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| ID | Type | Description | Link |
|---|---|---|---|
| Gelita-AG | Other Identifier | represented by: CRI - Collagen Research Institute Managing Director: Dr. Steffen Oesser Schauenburgerstr. 116 D-24118 K |
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| Name | Class |
|---|---|
| CRI Collagen Research Institute GmbH | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen Peptides | Experimental | Participants receive daily oral supplementation with specific collagen peptides for 24 weeks. Allocation is randomized 1:1 and double-blinded against placebo. Study visits occur at baseline (T0), 3 months (T1), and 6 months (T2). Blood samples are collected to assess telomere length (qPCR T/S ratio) and telomerase activity (TRAP), alongside inflammation and redox markers. Body composition (bioelectrical impedance), functional tests (muscle strength, mobility), and questionnaires on health and vitality are also performed. The intervention aims to test whether six months of collagen peptides stabilize or extend telomeres and increase telomerase activity compared with placebo. |
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| Maltodextrin | Placebo Comparator | Participants receive a daily placebo matched in a double-blind design for 24 weeks, with the same schedule of study visits at T0, T1, and T2 and the same assessments (blood biomarkers of telomere biology, inflammation/redox; body composition; functional tests; questionnaires) as the verum arm. Maltodextrin serves as the control to compare effects against collagen peptides in a randomized, double-blind, placebo-controlled, parallel-group trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen peptides | Dietary Supplement | 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 comparator to isolate collagen peptide effects in the parallel-group, double-blind trial. Products are approved as foods; prior clinical studies reported no substance-related adverse effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Telomere length | Changes in leukocyte telomere length (qPCR) from peripheral blood | Baseline and after supplementation (24 weeks) |
| Telomerase Activity | Changes telomerase activity measured via TRAP Assay from peripheral blood | Baseline and at the end of supplemention (24 weeks) |
| Change from baseline in DNA-oxidation markers | Change in DNA Damage measured through comet assay | Baseline and at the end of supplementation (24 weeks) |
| Change from baseline in micronuclei | Change in Micronulei measured through CBMN-Assay | Baseline and at the end of supplementation (24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Inflammatory markers | Changes in plasma concentrations of interleukins like IL-6, IL-10, TNF-alpha | Baseline and at the end of supplemention (24 weeks) |
| Change from baseline in the redox/antioxidant status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel König, Univ. Prof. Dr. | Contact | +43-1-4277-59130 | daniel.koenig@univie.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vienna, NuTraLab | Recruiting | Vienna | State of Vienna | 1070 | Austria |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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Interventional Study Model: Parallel Assignment - randomized, double-blind, placebo-controlled trial with two parallel groups (collagen peptides vs. placebo) in a 1:1 allocation
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| Maltodextrin (Placebo) | Dietary Supplement | Placebo instead of the collagen peptides |
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Change in superoxide dismutase and glutathione peroxidase via enzymatic tests to assess oxidative stress
| Baseline and at the end of supplementation (24 weeks) |
| Change from baseline in body composition | Change in fat-free mass and fat mass in kg by bioelectrical impedance | Basline, after 3 months and at the end of the supplementation (24 weeks) |
| Change from baseline metabolic markers | Change in serum lipid profile and fasting glucose in mg/dL | Baseline and at the end of supplementation (24 weeks) |
| Change from baseline in hormonal markers | Change in serum IGF-1and DHEA in ng/mL measured through immunoassays | Baseline and at the end of supplementation (24 weeks) |
| Change from baseline in muscle strength | Change in maximal handgrip and leg strength assessed by dynamometry and leg press | Baseline, after 3 months and at the end of supplementation (24 weeks) |
| Change from baseline in dietary intake | Change in dietary intake from standardized 3-day food records to contextualize biomarker and functional outcomes | Baseline, after 3 months and at the end of supplementation (24 weeks) |
| Change from baseline in patient-reported outcomes like quality of life | Change in health-related quality of life, measured through WHOQOL questionnaire | Baseline, after 3 months and at the end of supplementation (24 weeks) |
| Change of phase angle | Change in phase angle by bioelectrical impedance | Basline, after 3 months and at the end of the supplementation (24 weeks) |
| Change from baseline in Insulin | Baseline and at the end of supplementation (24 weeks) |
| Change from baseline in patient-reported outcomes like sleep quality | Change in health-related sleep quality meausred through Pittsburgh Sleep Quality Index questionnaire | Baseline, after 3 months and at the end of supplementation (24 weeks) |
| Change from baseline in patient-reported outcomes like health | Change in health measured through PHQ-9 questionnaire | Baseline, after 3 months and at the end of supplementation (24 weeks) |
| Change from baseline in patient-reported outcomes like fatigue | Change in health- related outcomes like fatigue measured through FAS questionnaire | Baseline, after 3 months and at the end of supplementation (24 weeks) |
| Change from baseline in oxidative stress | Change in glutathione (GSH) and glutathione disulfide (GSSG) | Baseline and at the end of supplementation (24 weeks) |