Post-prandial Glycaemic Controlling Effects of BSG in Singapore Adults With Metabolic Syndrome
- Conditions
- Diet ModificationMetabolic SyndromeDiabetes
- Interventions
- Dietary Supplement: bio-transformed BSG-containing biscuitsDietary Supplement: autoclaved BSG-containing biscuitsDietary Supplement: control biscuits
- Registration Number
- NCT05421780
- Lead Sponsor
- National University of Singapore
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 16
- 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);
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description bio-transformed BSG-containing group bio-transformed BSG-containing biscuits For each MTT, subjects are to consume 90 g bio-transformed BSG-containing biscuits as their breakfast within 15 mins. autoclaved BSG-containing group autoclaved BSG-containing biscuits For each MTT, subjects are to consume 90 g autoclaved BSG-containing biscuits as their breakfast within 15 mins. Control biscuits group control biscuits For each MTT, subjects are to consume 90 g control biscuits as their breakfast within 15 mins.
- Primary Outcome Measures
Name Time Method 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 amino acid concentration Every week (week 1, week 2 and week 3) Amino acid 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 blood glucose concentration Every week (week 1, week 2 and week 3) Glucose 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 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 cholesterol concentration Every week (week 1, week 2 and week 3) Total cholesterol concentration in the blood will be measured
- Secondary Outcome Measures
Name Time Method 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.
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 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 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
Trial Locations
- Locations (1)
Yujing Xu
🇸🇬Singapore, Singapore