The beneficial effect on mood of a food supplement based on S-adenosyl methionine and probiotics
| ISRCTN | ISRCTN42589932 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42589932 |
| Secondary identifying numbers | SAME122 |
- Submission date
- 03/08/2021
- Registration date
- 04/08/2021
- Last edited
- 22/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Subthreshold depression (SD) is defined by the presence of two or more depressive symptoms for 2 weeks and does not meet the criteria for diagnosis of major depressive disorder (MDD) and/or dysthymia (a milder but long-lasting form of depression), although it may have a significant impact on the quality of life.
S-adenosylmethionine (SAMe) has a significant mood-enhancing potential. Its effectiveness as an antidepressant has been shown by a number of clinical studies where it was used alone to combat mild to moderate depressive symptoms or in combination with traditional antidepressant medications in a moderate to severe course of disease. Differently from the other antidepressant drugs, SAMe is not associated with sexual and cognitive/memory dysfunction. In the light of available evidence, it is best to use SAMe in patients with mild to moderate depression, rather rely on conventional antidepressant medicines, which may increase the risk of toxicity in such patients.
Probiotics are health-promoting live microorganisms and are used to balance gut dysbiosis (bacteria imbalance), which may be associated with several intestinal and extraintestinal disorders. Certain probiotic species have been proved in clinical studies to have considerable antidepressant effects. The aim of this study is to find out whether supplementation with SAMe and probiotics is an effective treatment for depressive symptoms in patients with SD.
Who can participate?
People aged 18-65 years with altered mood
What does the study involve?
Participants are randomly allocated into two groups to take either a food supplement containing SAMe and probiotics or a placebo (dummy) supplement daily for 3 months. After a 1-month wash-out period where no treatment will be given participants switch groups for a further 3 months of treatment.
What are the possible benefits and risks of participating?
Participants may benefit from improved mood and will be continuously monitored about their health.
Where is the study run from?
Medical Doctor's Office site in Caserta (Italy)
When is the study starting and how long is it expected to run for?
September 2020 to March 2022
Who is funding the study?
Truffini & Reggè Farmaceutici S.r.l. (Italy)
Who is the main contact?
Prof. Maria Daglia (scientific)
maria.daglia@unina.it
Contact information
Scientific
Università degli Studi di Napoli Federico II
Domenico Montesano street, 49
Naples
80131
Italy
 ORCID ID |
0000-0002-4870-7713 |
|---|---|
| Phone | +39 (0)3331703492 |
| maria.daglia@unina.it |
Public
National Institute of Biostructures and Biosystems
Consorzio Interuniversitario
Viale delle Medaglie d'Oro 305
Rome
00136
Italy
| ORCID ID |
0000-0002-2877-9445 |
|---|---|
| Phone | +39 348 3854114 |
| alessandra.baldi.alimenti@gmail.com |
Study information
| Study design | Interventional monocentric randomized double-blind placebo-controlled cross-over clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | 40251_PIS.pdf |
| Scientific title | 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 |
| Study acronym | SAMEP |
| Study objectives | The primary outcome is to evaluate the efficacy of the food supplement containing S-adenosylmethionine (SAMe) and probiotics for maintaining normal mood by reducing subthreshold depression as a risk factor for major depression. This assessment was measured by administering to recruited subjects the validated Patient Health Questionnaire-9 (PHQ-9) and Hamilton Depression Rating Scale (HAM-D). |
| Ethics approval(s) | Approved 14/10/2020, ASL Caserta Campania Nord Ethics Committee (Via Unità Italiana, n28, 81100, Caserta, Italy; +39 (0)825203025; comitatoeticoav@agmail.it), ref: 1491 17/11/2020 |
| Health condition(s) or problem(s) studied | Subthreshold depression |
| Intervention | 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 group will be reassigned to the control group and vice versa (a further 3 months of treatment), as a cross-over design. The randomization sequence was generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC) and, the randomization list will be kept hidden. Subjects were assigned to each treatment group (food supplement or placebo) casually and by simple randomisation (1:1 allocation ratio). The randomization code will consist of a three-digit number as indicated in the respective Case Report Form (CRF). In the clinical study 80 participants were enrolled and divided into two groups (40 for each group): Group 1: daily intake of food supplement Group 2: daily intake of placebo Participants will undergo four visits (baseline = t0, after 12 weeks = t12, after 16 weeks (4 weeks of wash-out) = t16 and after 28 weeks = t28, in an outpatient setting. After each clinical visit, all data are filled in the CRF by physicians. In detail, the data acquired are: Baseline visit (t0): signature of informed consent; 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; PHQ-9 questionnaire; 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 treatment (t28): assessment of possible adverse reaction; PHQ-9 questionnaire; HAM-D questionnaire, urine analysis for the determination of cortisol and epinephrine. |
| Intervention type | Supplement |
| Primary outcome measure | 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 outcome measures | Urinary cortisol and epinephrine concentration assessed by urine analysis at t0, t12 and t28 |
| Overall study start date | 20/09/2020 |
| Completion date | 20/03/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/08/2021 |
| Date of final enrolment | 20/08/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
Caserta
81100
Italy
Sponsor information
Industry
Via Oslavia, 18
Milano
20134
Italy
| Phone | +39 (0)2 26412402 |
|---|---|
| truffini@truffini.it | |
| Website | http://www.truffini.it/index.htm |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 20/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-review journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Agostino Greco (agostino.greco@alice.it). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/08/2021 | No | Yes | ||
| Protocol file | 04/08/2021 | No | No | ||
| Results article | 27/10/2022 | 19/04/2024 | Yes | No |
Additional files
Editorial Notes
22/04/2024: A public contact was added.
19/04/2024: Publication reference added and the public contact was removed.
04/08/2021: Trial's existence confirmed by the ASL Caserta Campania Nord Ethics Committee.
