The beneficial effect on mood of a food supplement based on S-adenosyl methionine and probiotics

Double-blind, randomized, parallel-group, monocentric, placebo-controlled cross-over clinical trial on the effect of a food supplement based on S-adenosyl methionine and probiotics to promote normal mood by reducing subthreshold depression as a risk factor for major depression

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42589932

Enrollment

Registered

2021-08-04

Start date

2021-08-05

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subthreshold depression Mental and Behavioural Disorders

Interventions

Subjects will take the food supplement or placebo daily for 3 months, then a 1-month wash-out period is planned (no treatment will be administered). Subsequently, subjects assigned to the treated grou

information on the sociodemographic, clinical and symptomatologic characteristics of the participants

PHQ-9 questionnaire

HAM-D questionnaire, urine analysis for the determination of cortisol and epinephrine. After 12 weeks of treatment (t12): assessment of possible adverse reaction

HAM-D questionnaire, urine analysis for the determination of cortisol and epinephrine. After 16 weeks - t16 (4 weeks of wash-out)): PHQ-9 questionnaire

HAM-D questionnaire, After 28 weeks of the other tre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female in the age range 18 to 65 years 2. Subjects who present with altered mood tone 3. Subjects not eligible for antidepressant drugs 4. Subjects capable of understanding and complying with the requirements of the protocol

Exclusion criteria

Exclusion criteria: 1. Subjects with major depression remission or who have suffered from major depression in recent years 2. Individuals who have taken products, drugs or dietary supplements with psychological function activities in the 12 weeks prior to recruitment 3. Subjects suffering from diseases involving the cardiovascular, hepatic, renal, respiratory, nervous or lymphatic system 4. Subjects suffering from hypothyroidism 5. Pregnant women and those who have taken monoamine oxidase inhibitors in the 14 days prior to the recruitment

Design outcomes

Primary

Measure	Time frame
Subthreshold depression as a risk factor for major depression, measured by the Patient Health Questionnaire-9 (PHQ-9) and Hamilton Depression Rating Scale (HAMD21) at t0, t12, t16 and t28	—

Secondary

Measure	Time frame
Urinary cortisol and epinephrine concentration assessed by urine analysis at t0, t12 and t28	—

Countries

Italy

Contacts

Public ContactAlessandra Baldi

alessandra.baldi.alimenti@gmail.com+39 348 3854114

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026