Collagen Peptides and Cellular Aging

N/ANot Yet RecruitingNCT07456449

University of Vienna125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

125

Conditions

Longevity Healthy Aging

Interventions

Collagen peptidesDIETARY_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.

Maltodextrin (Placebo)DIETARY_SUPPLEMENT

Placebo instead of the collagen peptides

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Telomere length

Changes in leukocyte telomere length (qPCR) from peripheral blood

Time frame: Baseline and after supplementation (24 weeks)

Telomerase Activity

Changes telomerase activity measured via TRAP Assay from peripheral blood

Time frame: Baseline and at the end of supplemention (24 weeks)

Change from baseline in DNA-oxidation markers

Change in DNA Damage measured through comet assay

Time frame: Baseline and at the end of supplementation (24 weeks)

Change from baseline in micronuclei

Change in Micronulei measured through CBMN-Assay

Time frame: Baseline and at the end of supplementation (24 weeks)

Secondary Outcomes

Change from baseline in Inflammatory markers

Changes in plasma concentrations of interleukins like IL-6, IL-10, TNF-alpha

Time frame: Baseline and at the end of supplemention (24 weeks)

Change from baseline in the redox/antioxidant status

Change in superoxide dismutase and glutathione peroxidase via enzymatic tests to assess oxidative stress

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline, after 3 months and at the end of supplementation (24 weeks)

Change of phase angle

Change in phase angle by bioelectrical impedance

Time frame: Basline, after 3 months and at the end of the supplementation (24 weeks)

Change from baseline in Insulin

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: Baseline and at the end of supplementation (24 weeks)

Central Contacts

Daniel König, Univ. Prof. Dr.

CONTACT

+43-1-4277-59130 daniel.koenig@univie.ac.at

Data from ClinicalTrials.gov

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