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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes; Metabolic Syndrome; Diet Modification
• Intervention / Treatment: Dietary supplement: control biscuits; Dietary supplement: autoclaved BSG-containing biscuits; Dietary supplement: bio-transformed BSG-containing biscuits

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117543
    • Yujing Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control biscuits group; For each MTT, subjects are to consume 90 g control biscuits as their breakfast within 15 mins.	Dietary supplement: control biscuits; Consumption of plain biscuits as breakfast.
Experimental: autoclaved BSG-containing group; 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; Consumption of autoclaved BSG-containing biscuits as breakfast.
Experimental: bio-transformed BSG-containing group; 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 bio-transformed BSG-containing biscuits as breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood glucose concentration	Glucose concentration in the blood will be measured	Every week (week 1, week 2 and week 3)
Change in blood insulin concentration	Insulin concentration in the blood will be measured	Every week (week 1, week 2 and week 3)
Change in blood triglyceride concentration	Triglyceride concentration in the blood will be measured	Every week (week 1, week 2 and week 3)
Change in blood cholesterol concentration	Total cholesterol concentration in the blood will be measured	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	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	Every week (week 1, week 2 and week 3)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
Change in waist circumference	Waist circumference (in cm) will be measured	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.	Every week (week 1, week 2 and week 3)

Collaborators and Investigators

• Sponsor: National University of Singapore
• Collaborators: Ministry of Education, Singapore
• Investigators: Principal Investigator: Jung Eun Kim, Food Science and technology, Faculty of Science, National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): December 13, 2022
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; middle-aged and older adults; Post-prandial Glycaemic response; bio-transformed food
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: S16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No