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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05421780
• Other study ID #: S16
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: National University of Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: July 2024
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diet Modification
• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• autoclaved BSG-containing biscuits
Consumption of autoclaved BSG-containing biscuits as breakfast.
• bio-transformed BSG-containing biscuits
Consumption of bio-transformed BSG-containing biscuits as breakfast.
• control biscuits
Consumption of plain biscuits as breakfast.

Locations

Country	Name	City	State
Singapore	Yujing Xu	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University of Singapore	Ministry of Education, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood glucose concentration	Glucose concentration in the blood will be measured	Every week (week 1, week 2 and week 3)
Primary	Change in blood insulin concentration	Insulin concentration in the blood will be measured	Every week (week 1, week 2 and week 3)
Primary	Change in blood triglyceride concentration	Triglyceride concentration in the blood will be measured	Every week (week 1, week 2 and week 3)
Primary	Change in blood cholesterol concentration	Total cholesterol concentration in the blood will be measured	Every week (week 1, week 2 and week 3)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Change in waist circumference	Waist circumference (in cm) will be measured	Every week (week 1, week 2 and week 3)
Secondary	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)