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

Not Applicable

Active, not recruiting

• Conditions: Diet Modification; Metabolic Syndrome; Diabetes

• 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.

Study Timeline

• Study First Submitted: 2022-05-30
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-16
• Study Start: 2022-06-29
• Primary Completion: 2022-12-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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