L-serine and Strength Training in the Elderly
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Vienna
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Change in cognitive performance measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Study Overview
Brief Summary
This study investigates whether taking the amino acid L-serine, either alone or in combination with targeted strength training, can have a positive effect on mental performance, brain function, and physical fitness in older people.
Healthy, independent women and men aged 65 to 85 are eligible to participate. Participants will be randomly assigned to one of three groups: placebo, L-serine, or L-serine combined with strength training.
Cognitive tests, physical performance tests, and blood and brain tests will be conducted over a period of 48 weeks. The aim is to gain a better understanding of how nutrition and exercise can contribute to healthy aging.
Detailed Description
The study is a randomized, controlled, double-blind intervention study with three parallel groups of healthy older adults (aged 65-85). It investigates the effects of L-serine supplementation with and without accompanying strength training on cognitive, neural, molecular, and functional parameters over 48 weeks.
The primary endpoint is the change in cognitive performance, measured using the composite RBANS score. Secondary endpoints include structural and functional brain parameters (MRI, EEG), psychosocial parameters, markers of oxidative stress and immune function, as well as physical performance and muscle mass.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women between the ages of 65 and 85
- •Mini-Mental-State >23
- •Independently mobile, without aids (walker, cane, etc.)
Exclusion Criteria
- •Chronic diseases that contraindicate medical training therapy
- •Regular strength training (>1x/week) in the last 6 months before confinement
- •Frailty Index ≥ 3
- •Lack of written consent to test physical performance
- •Regular use of Cortison-containing medications or Antibiotika
- •MR-specific exclusion criteria: claustrophobia, metal equipment or other magnetic Material in or on the body
- •Non-compliance with the study protocol: <70% of the planned L-serine administration, <70% of the strength training
Arms & Interventions
L-serine and strength training
The L-serine and training group (LSERTRAIN) receives an L-serine supplement at a dose of 6 g/day over the entire study period (48 weeks).
Intervention: Strength training (Behavioral)
L-serine and strength training
The L-serine and training group (LSERTRAIN) receives an L-serine supplement at a dose of 6 g/day over the entire study period (48 weeks).
Intervention: L-serine supplementation (Dietary Supplement)
L-serine supplementation
The L-serine group (LSER) receives an L-serine supplement at a dose of 6 g/day over the entire study period (48 weeks).
Intervention: L-serine supplementation (Dietary Supplement)
Control
The control group (PLA) receives a placebo (cornstarch) throughout the entire study period (48 weeks)
Intervention: Control (cornstarch) (Dietary Supplement)
Outcomes
Primary Outcomes
Change in cognitive performance measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame: Baseline, 18 weeks and 48 weeks of intervention
Global cognitive performance will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), a standardized neuropsychological test battery that evaluates multiple cognitive domains including memory, attention, language, and visuospatial abilities. The primary outcome is the RBANS Total Scale Index score, which summarizes performance across the RBANS cognitive domains. RBANS index scores are standardized scores with a mean of 100 and a standard deviation of 15, typically ranging from approximately 40 to 160. Higher scores indicate better cognitive performance.
Secondary Outcomes
- Rate of torque development (Nm/s) will be measured at a joint angle of 60 degrees flexion (knee) and 40 degrees flexion (hip).(Baseline, 18 weeks and 48 weeks of intervention)
- Change in maximum and total work (J) of knee and hip flexion and extension(Baseline, 18 weeks and 48 of intervention)
- Position of peak torque and maximum range of motion (deg.)(Baseline, 18 weeks and 48 weeks of intervention)
- Change in cognitive domain performance measured by index scores of RBANS(Baseline, 18 weeks and 48 weeks of intervention)
- Change in hippocampal volume measured by magnetic resonance imaging (mm³)(Baseline and 48 weeks of intervention)
- Change in hippocampal functional connectivity measured by functional magnetic resonance imaging(Baseline and 48 weeks of intervention)
- Change in oscillatory brain activity measured using electroencephalography(Baseline, 18 weeks and 48 weeks of intervention)
- Change in hippocampal neurometabolite concentrations measured using single voxel magnetic resonance spectroscopy(Baseline, 18 weeks and 48 weeks of intervention)
- Change in lower limb muscle strength (isokinetic torque, dominant leg)(Baseline, 18 weeks and 48 weeks of intervention)
- Change in time to peak torque and time from peak to relaxation (sec.) during knee and hip extension and flexion(Baseline, 18 weeks and 48 weeks of intervention)
- Mean power (W) in knee and hip extension and flexion(Baseline, 18 weeks, and 48 weeks of intervention)
- Change in isometric handgrip strength(Baseline, 18 weeks, and 48 weeks of intervention)
- Change in upper extremity functional performance measured by the 30-Second Arm Curl Test(Baseline, 18 weeks, and 48 weeks of intervention)
- Change in upper-body flexibility (Back Scratch Test)(Baseline, 18 weeks, and 48 weeks of intervention)
- Change in Lower body flexibility (Chair Sit and Reach Test)(Baseline, 18 weeks, and 48 weeks of intervention)
- Change in lower extremity functional muscular performance measured by the 30-Second Chair Stand Test(Baseline, 18 weeks, and 48 weeks of intervention)
- Mobility and dynamic balance (Stand Up and Go Test)(Baseline, 18 weeks, and 48 weeks of intervention)
- Change in body composition measured by bioelectrical impedance analysis(Baseline, 18 weeks, and 48 weeks of intervention)
- Change in waist, abdominal, hip circumference (cm)(Baseline, 18 weeks, and 48 weeks of intervention)
- Change in oxidative stress marker such as malondialdehyde(Baseline, 18 weeks and 48 weeks of intervention)
- Change from baseline in inflammatory marker (e.g. IL-6, TNF-alpha)(Baseline, 18 weeks, and 48 weeks of intervention)
- Change from baseline in RNA and DNA gene expression(Baseline, 18 weeks, and 48 weeks of intervention)
- Change from baseline in chromosomal damage (number of micronuclei/1000 binucleated cells)(Baseline, 18 weeks, and 48 weeks of intervention)
- Change from baseline in the composition of gut-microbiota(Baseline, 18 weeks, and 48 weeks of intervention)
- Change from baseline in stool short-chain fatty acids (SCFAs)(Baseline, 18 weeks, and 48 weeks of intervention)
- Change from baseline in the metabolomic response(Baseline, 18 weeks, and 48 weeks of intervention)
- Change from baseline in the amino acid pattern(Baseline, 18 weeks, and 48 weeks of intervention)
- Nutritional habits(Baseline, 18 weeks and 48 weeks of intervention)
- Change in sleep quality measured by the Pittsburgh Sleep Quality Index(Baseline, 18 weeks, and 48 weeks)
- Change in quality of life measured by the World Health Organization Quality of Life Questionnaire(Baseline, 18 weeks, and 48 weeks)
Investigators
Karl-Heinz Wagner
Univ.-Prof. Dr.
University of Vienna