Glycaemic Control Effect of BSG and Underlying Gut - Related Mechanism in Singapore Adults With Metabolic Syndrome

NCT ID: NCT05529108

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2024-09-30

Brief Summary

The purpose of this research project is to assess the glycaemic controlling effects of consuming BSG and bio-transformed BSG-containing biscuits and its underlying gut - related mechanism in adults with MetS using in-vivo setting.

Detailed Description

This is a double-blind, randomised, parallel experiment, all subjects (38 adults in Singapore with MetS) will complete a 12-week intervention period. Subjects will be randomly assigned to consume their habitual diet with biscuit that either does not contain or contains autoclaved BSG or bio-transformed BSG for 12 weeks. Throughout the intervention, subjects will be assessed for glucose, insulin, lipid and amino acid responses, biomarkers of gut health, and as well as other markers of health.

Conditions

Metabolic Syndrome; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control biscuits group

Subjects are required to consume 90 g control biscuits as their breakfast everyday during 12-week intervention period.

Group Type: PLACEBO_COMPARATOR

control biscuits

Intervention Type: DIETARY_SUPPLEMENT

Consumption of plain biscuits everyday during intervention period.

autoclaved BSG-containing group

Subjects are required to consume 90 g autoclaved BSG-containing biscuits as their breakfast everyday during 12-week intervention period.

Group Type: EXPERIMENTAL

autoclaved BSG-containing biscuits

Intervention Type: DIETARY_SUPPLEMENT

Consumption of autoclaved BSG-containing biscuits everyday during intervention period.

bio-transformed BSG-containing group

Subjects are required to consume 90 g fermented BSG-containing biscuits as their breakfast everyday during 12-week intervention period.

Group Type: EXPERIMENTAL

bio-transformed BSG-containing biscuits

Intervention Type: DIETARY_SUPPLEMENT

Consumption of bio-transformed BSG-containing biscuits everyday during intervention period.

Interventions

control biscuits

Consumption of plain biscuits everyday during intervention period.

Intervention Type: DIETARY_SUPPLEMENT

autoclaved BSG-containing biscuits

Consumption of autoclaved BSG-containing biscuits everyday during intervention period.

Intervention Type: DIETARY_SUPPLEMENT

bio-transformed BSG-containing biscuits

Consumption of bio-transformed BSG-containing biscuits everyday during intervention period.

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

NUS Department of Food Science & Technology

Singapore, , Singapore

Countries

Singapore

Other Identifiers

S20

Identifier Type: -

Identifier Source: org_study_id