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| Name | Class |
|---|---|
| Ministry of Education, Singapore | OTHER_GOV |
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The purpose of this research project is to assess the glycaemic controlling effects of consuming BSG and bio-transformed BSG-containing biscuits and its underlying gut - related mechanism in adults with MetS using in-vivo setting.
This is a double-blind, randomised, parallel experiment, all subjects (38 adults in Singapore with MetS) will complete a 12-week intervention period. Subjects will be randomly assigned to consume their habitual diet with biscuit that either does not contain or contains autoclaved BSG or bio-transformed BSG for 12 weeks. Throughout the intervention, subjects will be assessed for glucose, insulin, lipid and amino acid responses, biomarkers of gut health, and as well as other markers of health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control biscuits group | Placebo Comparator | Subjects are required to consume 90 g control biscuits as their breakfast everyday during 12-week intervention period. |
|
| autoclaved BSG-containing group | Experimental | Subjects are required to consume 90 g autoclaved BSG-containing biscuits as their breakfast everyday during 12-week intervention period. |
|
| bio-transformed BSG-containing group | Experimental | Subjects are required to consume 90 g fermented BSG-containing biscuits as their breakfast everyday during 12-week intervention period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| control biscuits | Dietary Supplement | Consumption of plain biscuits everyday during intervention period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood glucose concentration | Glucose concentration in the blood will be measured | Every 12 week (week 0 and week 12) |
| Change in insulin concentration | Insulin concentration in the blood will be measured | Every 12 week (week 0 and week 12) |
| Change in blood triglyceride concentration | Triglyceride concentration in the blood will be measured | Every 12 week (week 0 and week 12) |
| Change in blood cholesterol concentration | Total cholesterol concentration in the blood will be measured | Every 12 week (week 0 and week 12) |
| Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration | Low-density Lipoprotein-cholesterol concentration in the blood will be measured | Every 12 week (week 0 and week 12) |
| Change in High-density Lipoprotein-cholesterol (HDL) concentration | High-density Lipoprotein-cholesterol concentration in the blood will be measured | Every 12 week (week 0 and week 12) |
| Change in Hemoglobin A1c (HbA1c) concentration | Hemoglobin A1c (HbA1c) concentration in the blood will be measured | Every 12 week (week 0 and week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in zonulin concentration | Zonulin concentration in the fecal will be measured | Every 12 week (week 0 and week 12) |
| Change in calprotectin levels | Calprotectin concentration in the fecal will be measured |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung Eun Kim | Food Science and technology, Faculty of Science, National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NUS Department of Food Science & Technology | Singapore | 117551 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41940993 | Derived | Xu Y, Leong ZN, Huang Y, Ma Z, Chan GCT, Kim JE. Impact of brewer's spent grain (BSG) and bio-transformed BSG biscuits on metabolic and gut health in adults with metabolic impairments: a randomized controlled trial. Eur J Nutr. 2026 Apr 6;65(3):113. doi: 10.1007/s00394-026-03952-6. |
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Electronic copies of the data with identifiable participant information will be kept on a secure website with access limited to Dr. Kim and Dr. Kim's research staff. All data will be de-identified prior to statistical analyses.
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| autoclaved BSG-containing biscuits | Dietary Supplement | Consumption of autoclaved BSG-containing biscuits everyday during intervention period. |
|
| bio-transformed BSG-containing biscuits | Dietary Supplement | Consumption of bio-transformed BSG-containing biscuits everyday during intervention period. |
|
| Change in C-reactive protein concentration |
C-reactive protein concentration in the blood will be measured |
| Every 12 week (week 0 and week 12) |
| Change in IL-6 concentration | IL-6 concentration in the blood will be measured | Every 12 week (week 0 and week 12) |
| Change in TNF-alpha concentration | TNF-alpha concentration in the blood will be measured | Every 12 week (week 0 and week 12) |
| Change in gut microbiome composition | Gut microbiome composition in the fecal will be measured | Every 12 week (week 0 and week 12) |
| Change in short chain fatty acids concentration | Short chain fatty acids concentration in the fecal will be measured | Every 12 week (week 0 and week 12) |
| Change in bile acid concentration | Bile acid concentration in the fecal will be measured | Every 12 week (week 0 and week 12) |
| Every 12 week (week 0 and week 12) |
| Change in appetite assessed by visual analogue scale | Visual analogue scale will be used to assess appetite. | Every 4 week (week 0, week 4, week 8 and week 12) |
| Change in sleep quality by questionnaire | Questionnaire will be used to assess sleep quality | Every 4 week (week 0, week 4, week 8 and week 12) |
| Change in weight and height | Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2 | Every 4 week (week 0, week 4, week 8 and week 12) |
| Change in blood pressure | Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor. | Every 4 week (week 0, week 4, week 8 and week 12) |
| Change in skin advanced glycation end products status | Skin advanced glycation end products status will be measured by a monitor. | Every 4 week (week 0, week 4, week 8 and week 12) |
| Change in dietary | Questionnaire will be used to record dietary | Every 4 week (week 0, week 4, week 8 and week 12) |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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