Diabetes, Diet Modification, Metabolic Syndrome
Conditions
Keywords
Metabolic Syndrome, middle-aged and older adults, Post-prandial Glycaemic response, bio-transformed food
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTautoclaved BSG-containing biscuits
Consumption of autoclaved BSG-containing biscuits as breakfast.
DIETARY_SUPPLEMENTbio-transformed BSG-containing biscuits
Consumption of bio-transformed BSG-containing biscuits as breakfast.
DIETARY_SUPPLEMENTcontrol biscuits
Consumption of plain biscuits as breakfast.
Sponsors
Ministry of Education, Singapore
National University of Singapore
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood amino acid concentration | Every week (week 1, week 2 and week 3) | Amino acid concentration in the blood will be measured |
| Change in blood insulin concentration | Every week (week 1, week 2 and week 3) | Insulin concentration in the blood will be measured |
| Change in blood triglyceride concentration | Every week (week 1, week 2 and week 3) | Triglyceride concentration in the blood will be measured |
| Change in blood cholesterol concentration | Every week (week 1, week 2 and week 3) | Total cholesterol concentration in the blood will be measured |
| Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration | Every week (week 1, week 2 and week 3) | Low-density Lipoprotein-cholesterol concentration in the blood will be measured |
| Change in High-density Lipoprotein-cholesterol (HDL) concentration | Every week (week 1, week 2 and week 3) | High-density Lipoprotein-cholesterol concentration in the blood will be measured |
| Change in blood glucose concentration | Every week (week 1, week 2 and week 3) | Glucose concentration in the blood will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in breath CH4 and H2 concentrations | Every week (week 1, week 2 and week 3) | CH4 and H2 concentrations will be measured by breath analyzer |
| Change in weight and height | Every week (week 1, week 2 and week 3) | Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m\^2 |
| Change in waist circumference | Every week (week 1, week 2 and week 3) | Waist circumference (in cm) will be measured |
| Change in blood pressure | Every week (week 1, week 2 and week 3) | Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor. |
| Change in appetite assessed by visual analogue scale | Every week (week 1, week 2 and week 3) | Visual analogue scale will be used to assess appetite. |
Countries
Singapore
Outcome results
None listed