Trial · NCT07880652
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Depressive Symptoms Assessed by the Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline to Week 8 | 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. |
| Secondary | Change in Depressive Symptoms Assessed by the Patient Health Questionnaire-9 (PHQ-9) | Baseline through Week 8 | 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). |
| Secondary | Change in Insomnia Symptoms Assessed by the Insomnia Severity Index (ISI) | Baseline through Week 8 | 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). |
| Secondary | Change in Anxiety Symptoms Assessed by the Beck Anxiety Inventory (BAI) | Baseline through Week 8 | 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). |
| Secondary | Change in Autistic Traits Assessed by the Autism-Spectrum Quotient (AQ) | Baseline through Week 8 | 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. |
| Secondary | Change in Mediterranean Diet Adherence Assessed by the Mediterranean Diet Adherence Screener (MEDAS) | Baseline through Week 8 | 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). |
| Other | Change in Bowel Habits Assessed by the Bowel Habit Questionnaire (BHQ) | Baseline through Week 8 | Bowel habits and related gastrointestinal characteristics will be assessed using the Bowel Habit Questionnaire (BHQ). |
| Other | Change in Gastrointestinal Symptoms Assessed by the Gastrointestinal Symptom Rating Scale (GSRS) | Baseline through Week 8 | 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). |
| Other | Change in Body Weight | Baseline to Week 8 | Body weight will be measured and reported in kilograms (kg). |
| Other | Change in Hip Circumference | Baseline to Week 8 | Hip circumference will be measured and reported in centimeters (cm). |
| Other | Change in Abdominal Circumference | Baseline to Week 8 | Abdominal circumference will be measured and reported in centimeters (cm). |
| Other | Change in Dietary Intake Assessed by Food Frequency Questionnaire (FFQ) | Baseline to Week 8 | Dietary intake and dietary habits will be assessed using a semi-quantitative 163-item Food Frequency Questionnaire (FFQ) validated in the Singapore population. |
| Other | Change in Gut Microbiome Composition and Diversity | Baseline to Week 8 | 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. |
| Other | Change in Oral Microbiome Composition and Diversity | Baseline to Week 8 | 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. |
| Other | Change in Urine Metabolites | Baseline to Week 8 | Urine samples will undergo metabolomic analysis to assess changes in urinary metabolites. |
| Other | Change in Hair Cortisol Level | Baseline to Week 8 | Hair samples will be collected for cortisol assay to assess changes in hair cortisol level. |
| Other | Change in Blood Metabolites | Baseline to Week 8 | Plasma and/or serum samples will undergo metabolomic analysis to assess changes in blood metabolites. |
| Other | Change in C-Reactive Protein (CRP) | Baseline to Week 8 | Blood C-reactive protein (CRP) will be measured as a neuroinflammatory marker. |
| Other | Change in Interleukin-1 Beta (IL-1β) | Baseline to Week 8 | Blood interleukin-1 beta (IL-1β) will be measured as a neuroinflammatory marker. |
| Other | Change in Interleukin-6 (IL-6) | Baseline to Week 8 | Blood interleukin-6 (IL-6) will be measured as a neuroinflammatory marker. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07880652/registered