An interventional study of autoclaved BSG-containing biscuits and bio-transformed BSG-containing biscuits in Metabolic Syndrome, Diabetes and Diet Modification, sponsored by National University of Singapore. Active, not recruiting at 1 site in Singapore. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by National University of Singapore · Not applicable, Interventional, and Prevention
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.
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →National University of Singapore is the lead sponsor of 206 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
For each MTT, subjects are to consume 90 g control biscuits as their breakfast within 15 mins.
Dietary Supplement: control biscuits
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
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
Consumption of autoclaved BSG-containing biscuits as breakfast.
Consumption of bio-transformed BSG-containing biscuits as breakfast.
Consumption of plain biscuits as breakfast.
Change in blood glucose concentration
Glucose concentration in the blood will be measured
Time frame: Every week (week 1, week 2 and week 3)
Change in blood insulin concentration
Insulin concentration in the blood will be measured
Time frame: Every week (week 1, week 2 and week 3)
Change in blood triglyceride concentration
Triglyceride concentration in the blood will be measured
Time frame: Every week (week 1, week 2 and week 3)
Change in blood cholesterol concentration
Total cholesterol concentration in the blood will be measured
Time frame: 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
Time frame: 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
Time frame: Every week (week 1, week 2 and week 3)
Change in blood amino acid concentration
Amino acid concentration in the blood will be measured
Time frame: Every week (week 1, week 2 and week 3)
Change in appetite assessed by visual analogue scale
Visual analogue scale will be used to assess appetite.
Time frame: 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
Time frame: 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
Time frame: Every week (week 1, week 2 and week 3)
Change in waist circumference
Waist circumference (in cm) will be measured
Time frame: 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.
Time frame: Every week (week 1, week 2 and week 3)
Plan to share: No — Electronic copies of the data with identifiable participant information will be kept on a secure website with access limited to Dr. Kim and Dr. Kim's research staff. All data will be de-identified prior to statistical analyses.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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National University of Singapore