Longevity, Healthy Aging, Biological Ageing
Conditions
Keywords
Aging, Collagen, Supplements, Patient Care, Healthspan, Cellular aging
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCollagen 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 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.
DIETARY_SUPPLEMENTMaltodextrin (Placebo)
Placebo instead of the collagen peptides
Sponsors
University of Vienna
CRI Collagen Research Institute GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Interventional Study Model: Parallel Assignment - randomized, double-blind, placebo-controlled trial with two parallel groups (collagen peptides vs. placebo) in a 1:1 allocation
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Telomere length | Baseline and after supplementation (24 weeks) | Changes in leukocyte telomere length (qPCR) from peripheral blood |
| Telomerase Activity | Baseline and at the end of supplemention (24 weeks) | Changes telomerase activity measured via TRAP Assay from peripheral blood |
| Change from baseline in DNA-oxidation markers | Baseline and at the end of supplementation (24 weeks) | Change in DNA Damage measured through comet assay |
| Change from baseline in micronuclei | Baseline and at the end of supplementation (24 weeks) | Change in Micronulei measured through CBMN-Assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Inflammatory markers | Baseline and at the end of supplemention (24 weeks) | Changes in plasma concentrations of interleukins like IL-6, IL-10, TNF-alpha |
| Change from baseline in the redox/antioxidant status | Baseline and at the end of supplementation (24 weeks) | Change in superoxide dismutase and glutathione peroxidase via enzymatic tests to assess oxidative stress |
| Change from baseline in body composition | Basline, after 3 months and at the end of the supplementation (24 weeks) | Change in fat-free mass and fat mass in kg by bioelectrical impedance |
| Change from baseline metabolic markers | Baseline and at the end of supplementation (24 weeks) | Change in serum lipid profile and fasting glucose in mg/dL |
| Change from baseline in hormonal markers | Baseline and at the end of supplementation (24 weeks) | Change in serum IGF-1and DHEA in ng/mL measured through immunoassays |
| Change from baseline in muscle strength | Baseline, after 3 months and at the end of supplementation (24 weeks) | Change in maximal handgrip and leg strength assessed by dynamometry and leg press |
| Change from baseline in dietary intake | Baseline, after 3 months and at the end of supplementation (24 weeks) | Change in dietary intake from standardized 3-day food records to contextualize biomarker and functional outcomes |
| Change from baseline in patient-reported outcomes like quality of life | Baseline, after 3 months and at the end of supplementation (24 weeks) | Change in health-related quality of life, measured through WHOQOL questionnaire |
| Change of phase angle | Basline, after 3 months and at the end of the supplementation (24 weeks) | Change in phase angle by bioelectrical impedance |
| Change from baseline in Insulin | Baseline and at the end of supplementation (24 weeks) | — |
| Change from baseline in patient-reported outcomes like sleep quality | Baseline, after 3 months and at the end of supplementation (24 weeks) | Change in health-related sleep quality meausred through Pittsburgh Sleep Quality Index questionnaire |
| Change from baseline in patient-reported outcomes like health | Baseline, after 3 months and at the end of supplementation (24 weeks) | Change in health measured through PHQ-9 questionnaire |
| Change from baseline in patient-reported outcomes like fatigue | Baseline, after 3 months and at the end of supplementation (24 weeks) | Change in health- related outcomes like fatigue measured through FAS questionnaire |
| Change from baseline in oxidative stress | Baseline and at the end of supplementation (24 weeks) | Change in glutathione (GSH) and glutathione disulfide (GSSG) |
Contacts
CONTACTDaniel König, Univ. Prof. Dr.
Outcome results
None listed