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

NCT ID: NCT05421780

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-29
• Study Completion Date: 2024-07-31

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.

Conditions

Metabolic Syndrome; Diabetes; Diet Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control biscuits group

For each MTT, subjects are to consume 90 g control biscuits as their breakfast within 15 mins.

Group Type: PLACEBO_COMPARATOR

control biscuits

Intervention Type: DIETARY_SUPPLEMENT

Consumption of plain biscuits as breakfast.

autoclaved BSG-containing group

For each MTT, subjects are to consume 90 g autoclaved BSG-containing biscuits as their breakfast within 15 mins.

Group Type: EXPERIMENTAL

autoclaved BSG-containing biscuits

Intervention Type: DIETARY_SUPPLEMENT

Consumption of autoclaved BSG-containing biscuits as breakfast.

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.

Group Type: EXPERIMENTAL

bio-transformed BSG-containing biscuits

Intervention Type: DIETARY_SUPPLEMENT

Consumption of bio-transformed BSG-containing biscuits as breakfast.

Interventions

autoclaved BSG-containing biscuits

Consumption of autoclaved BSG-containing biscuits as breakfast.

Intervention Type: DIETARY_SUPPLEMENT

bio-transformed BSG-containing biscuits

Consumption of bio-transformed BSG-containing biscuits as breakfast.

Intervention Type: DIETARY_SUPPLEMENT

control biscuits

Consumption of plain biscuits as breakfast.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Education, Singapore

OTHER_GOV

Sponsor Role: collaborator

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Jung Eun Kim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jung Eun Kim

Role: PRINCIPAL_INVESTIGATOR

Food Science and technology, Faculty of Science, National University of Singapore

Locations

Yujing Xu

Singapore, , Singapore

Countries

Singapore

Other Identifiers

S16

Identifier Type: -

Identifier Source: org_study_id