Actively Recruiting
Effects of Specific Amino Acid Supplementation and Lifestyle Factors on Brain Ageing
Led by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Updated on 2026-03-27
84
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this clinical trial is to investigate the effects of L-serine supplementation on cognitive decline and psychosocial functioning in older adults with late-life depression (LLD). The study will evaluate changes in depressive symptoms, neural and cognitive functioning, and will assess neurophysiological, metagenomic, and biochemical alterations associated with L-serine supplementation compared with placebo. The main research questions are: * Does L-serine supplementation affect cognitive function, depressive symptoms, and neural functioning in individuals with late-life depression? * What biological mechanisms may underlie the effects of L-serine on cognitive decline? Participants will be randomly assigned to one of two study arms: an intervention group (total n = 42) receiving L-serine at a dose of 6 g/day for 48 weeks, and a placebo group (total n = 42) receiving 6 g/day of maltodextrin for the same duration. All participants will be assessed at three time points: T0 (baseline, prior to trial initiation), T18 (after 18 weeks), and T48 (after 48 weeks, at the end of the trial). At each assessment, participants will: * complete clinical questionnaires and a neuropsychological assessment; * provide blood, fecal, and urine samples; * undergo electroencephalographic (EEG) recordings.
CONDITIONS
Official Title
Effects of Specific Amino Acid Supplementation and Lifestyle Factors on Brain Ageing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65-85 years
- Depressive symptoms with a score of 5 or higher on the Geriatric Depression Scale-15 items (GDS-15) or Patient Health Questionnaire-9 (PHQ-9)
You will not qualify if you...
- Diagnosis of dementia
- Use of antibiotics or anti-inflammatory medications within the previous 8 weeks
- Active gastrointestinal disease
- Severe chronic medical conditions such as advanced-stage cancer, severe cardiac or renal disorders, or other debilitating diseases
- Renal dysfunction
- Current alcohol or substance abuse
- Major surgical procedures within the previous 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy, 25125
Actively Recruiting
Research Team
M
Moira Marizzoni, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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