Post-prandial Glycaemic Controlling Effects of BSG in Singapore Adults With Metabolic Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to assess the glycaemic controlling effects of BSG and bio-transformed BSG-containing biscuits in Singapore adults with MetS. The investigators hypothesized that consumption of BSG and bio-transformed BSG containing biscuit will improve glycaemic control.

Detailed Description
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This is a double-blind, randomised, crossover experiment. During the 3-week, 19 subjects will participate in a 3 meal tolerance test (MTT). During each MTT session, all subjects are required to consume 90 g biscuits (either control, autoclaved BSG or bio-transformed BSG biscuits) and monitored over a period of 240 minutes. All three types of biscuits will be consumed at a randomised sequence during this 3-week period. Post-prandial blood glucose, insulin, lipid and amino acid responses, breath analysis, body composition, blood pressure, appetite assessment, and any other glycaemic biomarkers will be assessed.

Official Title
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Impact of Brewer's Spent Grain (BSG) and Bio-transformed BSG Biscuits on Post-prandial Glycaemic Controlling Effects in Singapore Adults With Metabolic Syndrome

Conditions
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Metabolic Syndrome, Diabetes, Diet Modification

Intervention / Treatment
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* Dietary Supplement: autoclaved BSG-containing biscuits
* Dietary Supplement: bio-transformed BSG-containing biscuits
* Dietary Supplement: control 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control biscuits group<br>For each MTT, subjects are to consume 90 g control biscuits as their breakfast within 15 mins. | Dietary Supplement: control biscuits<br>* Consumption of plain biscuits as breakfast.<br>|
| Experimental: autoclaved BSG-containing group<br>For each MTT, subjects are to consume 90 g autoclaved BSG-containing biscuits as their breakfast within 15 mins. | Dietary Supplement: autoclaved BSG-containing biscuits<br>* Consumption of autoclaved BSG-containing biscuits as breakfast.<br>|
| Experimental: bio-transformed BSG-containing group<br>For each MTT, subjects are to consume 90 g bio-transformed BSG-containing biscuits as their breakfast within 15 mins. | Dietary Supplement: bio-transformed BSG-containing biscuits<br>* Consumption of bio-transformed BSG-containing biscuits as breakfast.<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 week (week 1, week 2 and week 3) | 
| Change in blood insulin concentration | Insulin concentration in the blood will be measured | Every week (week 1, week 2 and week 3) | 
| Change in blood triglyceride concentration | Triglyceride concentration in the blood will be measured | Every week (week 1, week 2 and week 3) | 
| Change in blood cholesterol concentration | Total cholesterol concentration in the blood will be measured | Every week (week 1, week 2 and week 3) | 
| Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration | Low-density Lipoprotein-cholesterol concentration in the blood will be measured | Every week (week 1, week 2 and week 3) | 
| Change in High-density Lipoprotein-cholesterol (HDL) concentration | High-density Lipoprotein-cholesterol concentration in the blood will be measured | Every week (week 1, week 2 and week 3) | 
| Change in blood amino acid concentration | Amino acid concentration in the blood will be measured | Every week (week 1, week 2 and week 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in appetite assessed by visual analogue scale | Visual analogue scale will be used to assess appetite. | Every week (week 1, week 2 and week 3) | 
| Change in breath CH4 and H2 concentrations | CH4 and H2 concentrations will be measured by breath analyzer | Every week (week 1, week 2 and week 3) | 
| Change in weight and height | Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2 | Every week (week 1, week 2 and week 3) | 
| Change in waist circumference | Waist circumference (in cm) will be measured | Every week (week 1, week 2 and week 3) | 
| Change in blood pressure | Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor. | Every week (week 1, week 2 and week 3) | 

 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