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Recruiting NCT07497347

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

No phase Interventional Late-Life Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: L-serine supplementation, Placebo.
Who it may be relevant to
Registry conditions: Late-Life Depression. Basic parameters: 65 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Translational Investigation of Specific Amino Acid Supplementation and Lifestyle Factors in Brain Ageing

Overview

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 outcome measures

  • Geriatric Depression Scale - 15 [Time frame: Baseline; week 18; week 48 (end of the trial)]
  • Repeatable Battery for the Assessment of Neuropsychological Status [Time frame: Baseline, Week 18; Week 48 (end of the trial)]
  • Patient Health Questionnaire - 9 [Time frame: Baseline; Week 18; Week 48 (end of the trial)]
  • Montgomery-Åsberg Depression Rating Scale [Time frame: Baseline, Week 18; Week 48 (end of the trial)]
  • World Health Organization Quality of Life - Bref [Time frame: Baseline, Week 18, Week 48 (end of trial)]
Secondary outcome measures (6)
  • Electroencephalogram -derived neurophysiological metrics [Time frame: Baseline, Week 48 (end of the trial)]
  • Gut Microbiome Composition [Time frame: Baseline, Week 18; Week 48 (end of trial)]
  • Immune-related biomarkers levels [Time frame: Baseline; Week 18; Week 48 (end of trial)]
  • Amino acid and metabolic biomarkers [Time frame: Baseline, Week 18; Week 48 (end of trial)]
  • Neuroendocrine and stress-related biomarkers [Time frame: Baseline, Week 18; Week 48]
  • Neurotrophic biomarkers [Time frame: Baseline, Week 18; Week 48]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Italy · 1 center
  • IRCCS Centro San Giovanni di Dio Fatebenefratelli — Brescia

Identifiers

NCT: NCT07497347 · CERP-2024-23685719

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗