Actively Recruiting

Phase Not Applicable
Age: 65Years - 85Years
All Genders
NCT07497347

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

Age: 65Years - 85Years
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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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