- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07456449
Collagen Peptides and Cellular Aging
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel König, Univ. Prof. Dr.
- Phone Number: +43-1-4277-59130
- Email: daniel.koenig@univie.ac.at
Study Locations
-
-
State of Vienna
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Vienna, State of Vienna, Austria, 1070
- Recruiting
- University of Vienna, NuTraLab
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Contact:
- Jana Schneider
- Phone Number: +43-1-9909194-200
- Email: jana.schneider@univie.ac.at
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Collagen Peptides
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.
|
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. |
|
Placebo Comparator: Maltodextrin
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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Placebo instead of the collagen peptides
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Telomere length
Time Frame: Baseline and after supplementation (24 weeks)
|
Changes in leukocyte telomere length (qPCR) from peripheral blood
|
Baseline and after supplementation (24 weeks)
|
|
Telomerase Activity
Time Frame: Baseline and at the end of supplemention (24 weeks)
|
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
Time Frame: Baseline and at the end of supplementation (24 weeks)
|
Change in DNA Damage measured through comet assay
|
Baseline and at the end of supplementation (24 weeks)
|
|
Change from baseline in micronuclei
Time Frame: Baseline and at the end of supplementation (24 weeks)
|
Change in Micronulei measured through CBMN-Assay
|
Baseline and at the end of supplementation (24 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Inflammatory markers
Time Frame: Baseline and at the end of supplemention (24 weeks)
|
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
Time Frame: Baseline and at the end of supplementation (24 weeks)
|
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
Time Frame: 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
|
Basline, after 3 months and at the end of the supplementation (24 weeks)
|
|
Change from baseline metabolic markers
Time Frame: Baseline and at the end of supplementation (24 weeks)
|
Change in serum lipid profile and fasting glucose in mg/dL
|
Baseline and at the end of supplementation (24 weeks)
|
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Change from baseline in hormonal markers
Time Frame: Baseline and at the end of supplementation (24 weeks)
|
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
Time Frame: 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
|
Baseline, after 3 months and at the end of supplementation (24 weeks)
|
|
Change from baseline in dietary intake
Time Frame: 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
|
Baseline, after 3 months and at the end of supplementation (24 weeks)
|
|
Change from baseline in patient-reported outcomes like quality of life
Time Frame: Baseline, after 3 months and at the end of supplementation (24 weeks)
|
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
Time Frame: Basline, after 3 months and at the end of the supplementation (24 weeks)
|
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
Time Frame: Baseline and at the end of supplementation (24 weeks)
|
Baseline and at the end of supplementation (24 weeks)
|
|
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Change from baseline in patient-reported outcomes like sleep quality
Time Frame: 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
|
Baseline, after 3 months and at the end of supplementation (24 weeks)
|
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Change from baseline in patient-reported outcomes like health
Time Frame: Baseline, after 3 months and at the end of supplementation (24 weeks)
|
Change in health measured through PHQ-9 questionnaire
|
Baseline, after 3 months and at the end of supplementation (24 weeks)
|
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Change from baseline in patient-reported outcomes like fatigue
Time Frame: Baseline, after 3 months and at the end of supplementation (24 weeks)
|
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
Time Frame: Baseline and at the end of supplementation (24 weeks)
|
Change in glutathione (GSH) and glutathione disulfide (GSSG)
|
Baseline and at the end of supplementation (24 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01400
- Gelita-AG (Other Identifier: represented by: CRI - Collagen Research Institute Managing Director: Dr. Steffen Oesser Schauenburgerstr. 116 D-24118 K)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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