Recruiting

Effects of Specific Amino Acid Supplementation and Lifestyle Factors on Brain Ageing

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ClinicalTrials.gov IDNCT07497347

PhaseNA

Enrollment84

SponsorIRCCS Centro San Giovanni di Dio Fatebenefratelli

Age65 Years and older

SexALL

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Conditions studied

Late-Life Depression

About this study

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.

Interventions

Dietary Supplement: L-serine supplementation — Participants randomized to the experimental arm will receive L-serine supplementation (6 g/day), administered orally as a single stick per day for a total duration of 48 weeks.
Other: Placebo — Participants randomized to the Placebo arm will receive Maltodextrine supplementation (6 g/day), administered orally as a single stick per day for a total duration of 48 weeks.

Primary outcomes

Geriatric Depression Scale - 15 (Baseline; week 18; week 48 (end of the trial))
Repeatable Battery for the Assessment of Neuropsychological Status (Baseline, Week 18; Week 48 (end of the trial))
Patient Health Questionnaire - 9 (Baseline; Week 18; Week 48 (end of the trial))
Montgomery-Åsberg Depression Rating Scale (Baseline, Week 18; Week 48 (end of the trial))
World Health Organization Quality of Life - Bref (Baseline, Week 18, Week 48 (end of trial))

Eligibility information

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.

Study locations

IRCCS Centro San Giovanni di Dio Fatebenefratelli, Brescia, 25125 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.