Glycaemic Control Effect of BSG and Underlying Gut - Related Mechanism in Singapore Adults With Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Brewer's Spent Grain (BSG) and Bio-transformed BSG Biscuits on Glycaemic Control and Gut Health in Singapore Adults With Metabolic Syndrome

Conditions
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Metabolic Syndrome, Diabetes

Intervention / Treatment
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* Dietary Supplement: control biscuits
* Dietary Supplement: autoclaved BSG-containing biscuits
* Dietary Supplement: bio-transformed BSG-containing biscuits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants, aged 35-85 years old English-literate and able to give informed consent in English Willing to follow the study procedures Meet any 3 of the 5 following NCEP-ATP III MetS criteria: waist circumference > 102 cm (male), > 88 cm (female) (For Asian population: Waist circumference > 90 cm (male), > 80 cm (female)); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/85 mmHg or on medication); Exclusion Criteria: Significant change in weight (≥ 3 kg body weight) during the past 3 months Allergy to barley, wheat, corn, egg, or other ingredients found inside the biscuits. Acute illness at the study baseline Exercising vigorously* over the past 3 months. *Defined as having > 6 metabolic equivalents of exercise daily; approximately 20 mins of moderate intensity exercise (e.g. slow jogging) a day Following any restricted diet (e.g. vegetarian) Smoking Have a daily intake of more than 2 alcoholic drinks per day Taking dietary supplements or food which may impact the outcome of interests (e.g. fermented foods, probiotic supplement etc.) Consumption of antibiotics over past 3 months. Pregnant, lactating, or planning pregnancy in the next 6 months Insufficient venous access to allow the blood collection Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 3 years prior to the intervention participation High current intake of fibre* from brown rice or wholemeal products. *High, moderate or low intake taken as ≥ 6 servings, 4 - 5 servings, and ≤ 3 servings daily respectively based on My Healthy Plate guidelines High current intake of fibre* from vegetables. * High, moderate or low intake taken as ≥ 2 servings, 2 servings, and ≤ 1 serving respectively based on My Healthy Plate guidelines

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control biscuits group<br>Subjects are required to consume 90 g control biscuits as their breakfast everyday during 12-week intervention period. | Dietary Supplement: control biscuits<br>* Consumption of plain biscuits everyday during intervention period.<br>|
| Experimental: autoclaved BSG-containing group<br>Subjects are required to consume 90 g autoclaved BSG-containing biscuits as their breakfast everyday during 12-week intervention period. | Dietary Supplement: autoclaved BSG-containing biscuits<br>* Consumption of autoclaved BSG-containing biscuits everyday during intervention period.<br>|
| Experimental: bio-transformed BSG-containing group<br>Subjects are required to consume 90 g fermented BSG-containing biscuits as their breakfast everyday during 12-week intervention period. | Dietary Supplement: bio-transformed BSG-containing biscuits<br>* Consumption of bio-transformed BSG-containing biscuits everyday during intervention period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome, middle-aged and older adults, Post-prandial Glycaemic response, bio-transformed food