Effects of Specific Amino Acid Supplementation and Lifestyle Factors on Brain Ageing
Recruiting · NCT07497347 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Age 65-85 years;
- Presence of depressive symptoms, defined as a score ≥ 5 on the Geriatric Depression Scale-15 items (GDS-15) or ≥ 5 on the Patient Health Questionnaire-9 (PHQ-9).
Exclusion criteria
- Diagnosis of dementia;
- Use of antibiotics or anti-inflammatory medications within the previous 8 weeks;
- Active gastrointestinal disease;
- Severe chronic medical conditions (e.g., 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.
Where it is running
1 location listed.
- IRCCS Centro San Giovanni di Dio Fatebenefratelli - Brescia, Italy