NCT07497347 Effects of Specific Amino Acid Supplementation and Lifestyle Factors on Brain Ageing
| NCT ID | NCT07497347 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli |
| Condition | Late-Life Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2026-03-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07497347 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 85 Years, studying Late-Life Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07497347 currently recruiting?
Yes, NCT07497347 is actively recruiting participants. Contact the research team at mmarizzoni@fatebenefratelli.eu for enrollment information.
Where is the NCT07497347 trial being conducted?
This trial is being conducted at Brescia, Italy.
Who is sponsoring the NCT07497347 clinical trial?
NCT07497347 is sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. The trial plans to enroll 84 participants.
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