An interventional study of Mediterranean-Style Dietary Education Program and Befriending in Subthreshold Depression, sponsored by Institute of Mental Health, Singapore. Not yet recruiting at 1 site in Singapore. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Institute of Mental Health, Singapore · Not applicable, Interventional, and Treatment
This randomized controlled trial evaluates the efficacy of an 8-week dietary education intervention in adults with subthreshold depression. Participants will be randomly assigned in a 1:1 ratio to either a dietary education intervention or a befriending control condition. The dietary intervention consists of online dietary education and counseling designed to encourage a Mediterranean dietary pattern. The control group will receive online befriending sessions of similar frequency and duration. The study will evaluate changes in depressive symptoms and investigate changes in oral and gut microbiota, dietary measures, psychiatric symptoms, metabolic measures, and neurobiological markers.
Subthreshold depression is characterized by clinically significant depressive symptoms that do not meet the full diagnostic criteria for major depressive disorder and represents an important opportunity for early intervention.
Emerging evidence suggests that diet and the gut microbiome may be involved in mental health through the microbiota-gut-brain axis. However, evidence regarding dietary interventions specifically for individuals with subthreshold depression is limited, particularly in Asian populations, and the mechanisms linking dietary changes with depressive symptoms remain incompletely understood.
The MIND-Trial is an 8-week, parallel-group, open-label randomized controlled trial involving 64 adults with subthreshold depression. Participants will be randomized 1:1 to a dietary education intervention or a befriending control condition.
Participants assigned to the intervention will receive online dietary education and counseling every two weeks, incorporating tailored dietary recommendations and structured goal setting to encourage a Mediterranean dietary pattern. Participants assigned to the control condition will receive online befriending sessions at the same frequency and duration, involving conversations on neutral topics.
The study will evaluate depressive symptoms as well as dietary adherence, other psychiatric and gastrointestinal symptoms, anthropometric measures, oral and gut microbiota, metabolites, and neurobiological markers.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 64 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Institute of Mental Health, Singapore is the lead sponsor of 18 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive an online dietary education program delivered via Microsoft Teams by qualified dietitians or trained research staff every two weeks over an 8-week period. Sessions will incorporate internet-delivered dietary education, counseling, tailored dietary recommendations, and structured goal setting to encourage a Mediterranean dietary pattern. Participants will receive a S$25 grocery voucher and a list of Mediterranean foods every two weeks.
Behavioral: Mediterranean-Style Dietary Education Program
Participants will receive befriending sessions via Microsoft Teams at the same frequency and duration as the dietary education sessions. Researchers will engage participants in conversations on neutral topics such as hobbies, books, music, and sports. Participants will receive a S$25 grocery voucher every two weeks and will be advised to continue their usual grocery shopping habits.
Behavioral: Befriending
An 8-week online dietary education and counseling program delivered every two weeks, incorporating tailored dietary recommendations and structured goal setting to encourage adoption of a Mediterranean dietary pattern.
Online befriending sessions delivered at the same frequency and duration as the dietary education intervention. Sessions consist of conversations on neutral topics intended to maintain engagement and control for nonspecific factors such as attention, treatment expectancy, and engagement.
Change in Depressive Symptoms Assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Depressive symptoms will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item self-report measure with a total score ranging from 0 to 60. Higher scores indicate greater severity of depressive symptoms (i.e., a worse outcome). Change in CES-D score from baseline will be compared between the dietary education intervention and befriending control groups.
Time frame: Baseline to Week 8
Change in Depressive Symptoms Assessed by the Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items and has a total score ranging from 0 to 27. Higher scores indicate greater severity of depressive symptoms (i.e., a worse outcome).
Time frame: Baseline through Week 8
Change in Insomnia Symptoms Assessed by the Insomnia Severity Index (ISI)
Insomnia symptoms will be assessed using the Insomnia Severity Index (ISI). The ISI consists of 7 items and has a total score ranging from 0 to 28. Higher scores indicate greater severity of insomnia symptoms (i.e., a worse outcome).
Time frame: Baseline through Week 8
Change in Anxiety Symptoms Assessed by the Beck Anxiety Inventory (BAI)
Anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI). The BAI consists of 21 items and has a total score ranging from 0 to 63. Higher scores indicate greater severity of anxiety symptoms (i.e., a worse outcome).
Time frame: Baseline through Week 8
Change in Autistic Traits Assessed by the Autism-Spectrum Quotient (AQ)
Autistic traits will be assessed using the Autism-Spectrum Quotient (AQ). The AQ consists of 50 items and has a total score ranging from 0 to 50 using the standard binary scoring method. Higher scores indicate a greater level of autistic traits.
Time frame: Baseline through Week 8
Change in Mediterranean Diet Adherence Assessed by the Mediterranean Diet Adherence Screener (MEDAS)
Adherence to a Mediterranean dietary pattern will be assessed using the Mediterranean Diet Adherence Screener (MEDAS). The MEDAS consists of 14 items and has a total score ranging from 0 to 14. Higher scores indicate greater adherence to a Mediterranean dietary pattern (i.e., a better outcome).
Time frame: Baseline through Week 8
Change in Bowel Habits Assessed by the Bowel Habit Questionnaire (BHQ)
Bowel habits and related gastrointestinal characteristics will be assessed using the Bowel Habit Questionnaire (BHQ).
Time frame: Baseline through Week 8
Change in Gastrointestinal Symptoms Assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The questionnaire assesses reflux, abdominal pain, indigestion, diarrhea, and constipation symptoms. Each symptom is rated on a 7-point scale ranging from 1 (no discomfort) to 7 (very severe discomfort). Higher scores indicate greater gastrointestinal symptom severity (i.e., a worse outcome).
Time frame: Baseline through Week 8
Change in Body Weight
Body weight will be measured and reported in kilograms (kg).
Time frame: Baseline to Week 8
Change in Hip Circumference
Hip circumference will be measured and reported in centimeters (cm).
Time frame: Baseline to Week 8
Change in Abdominal Circumference
Abdominal circumference will be measured and reported in centimeters (cm).
Time frame: Baseline to Week 8
Change in Dietary Intake Assessed by Food Frequency Questionnaire (FFQ)
Dietary intake and dietary habits will be assessed using a semi-quantitative 163-item Food Frequency Questionnaire (FFQ) validated in the Singapore population.
Time frame: Baseline to Week 8
Change in Gut Microbiome Composition and Diversity
Gut microbiome will be assessed from stool samples using shotgun metagenomic sequencing. Microbial relative abundance, alpha diversity, beta diversity, taxonomic composition, and functional potential will be evaluated.
Time frame: Baseline to Week 8
Change in Oral Microbiome Composition and Diversity
Oral microbiome will be assessed from saliva samples using shotgun metagenomic sequencing. Microbial relative abundance, alpha diversity, beta diversity, taxonomic composition, and functional potential will be evaluated.
Time frame: Baseline to Week 8
Change in Urine Metabolites
Urine samples will undergo metabolomic analysis to assess changes in urinary metabolites.
Time frame: Baseline to Week 8
Change in Hair Cortisol Level
Hair samples will be collected for cortisol assay to assess changes in hair cortisol level.
Time frame: Baseline to Week 8
Change in Blood Metabolites
Plasma and/or serum samples will undergo metabolomic analysis to assess changes in blood metabolites.
Time frame: Baseline to Week 8
Change in C-Reactive Protein (CRP)
Blood C-reactive protein (CRP) will be measured as a neuroinflammatory marker.
Time frame: Baseline to Week 8
Change in Interleukin-1 Beta (IL-1β)
Blood interleukin-1 beta (IL-1β) will be measured as a neuroinflammatory marker.
Time frame: Baseline to Week 8
Change in Interleukin-6 (IL-6)
Blood interleukin-6 (IL-6) will be measured as a neuroinflammatory marker.
Time frame: Baseline to Week 8
Change in Tumor Necrosis Factor (TNF)
Blood tumor necrosis factor (TNF) will be measured as a neuroinflammatory marker.
Time frame: Baseline to Week 8
Change in Brain-Derived Neurotrophic Factor (BDNF)
Blood brain-derived neurotrophic factor (BDNF) will be measured as a neuroplasticity marker.
Time frame: Baseline to Week 8
Change in Plasma Cortisol Level
Plasma cortisol will be measured as a neuroendocrine-related marker.
Time frame: Baseline to Week 8
Change in Blood Glucose
Blood glucose concentration will be measured.
Time frame: Baseline to Week 8
Change in High-Density Lipoprotein (HDL) Cholesterol
High-density lipoprotein (HDL) cholesterol concentration will be measured.
Time frame: Baseline to Week 8
Change in Low-Density Lipoprotein (LDL) Cholesterol
Low-density lipoprotein (LDL) cholesterol concentration will be measured.
Time frame: Baseline to Week 8
Change in Triglycerides
Blood triglyceride concentration will be measured.
Time frame: Baseline to Week 8
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 24 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Institute of Mental Health, Singapore