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

Impact of Brewer's Spent Grain (BSG) and Bio-transformed BSG Biscuits on Glycaemic Control and Gut Health in Singapore Adults With Metabolic Syndrome

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes; Metabolic Syndrome
• 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, 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.

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117551
    • NUS Department of Food Science & Technology

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: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control biscuits group; Subjects are required to consume 90 g control biscuits as their breakfast everyday during 12-week intervention period.	Dietary supplement: control biscuits; Consumption of plain biscuits everyday during intervention period.
Experimental: autoclaved BSG-containing group; Subjects are required to consume 90 g autoclaved BSG-containing biscuits as their breakfast everyday during 12-week intervention period.	Dietary supplement: autoclaved BSG-containing biscuits; Consumption of autoclaved BSG-containing biscuits everyday during intervention period.
Experimental: 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.	Dietary supplement: bio-transformed BSG-containing biscuits; Consumption of bio-transformed BSG-containing biscuits everyday during intervention period.

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 12 week (week 0 and week 12)
Change in insulin concentration	Insulin concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Change in blood triglyceride concentration	Triglyceride concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Change in blood cholesterol concentration	Total cholesterol concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration	Low-density Lipoprotein-cholesterol concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Change in High-density Lipoprotein-cholesterol (HDL) concentration	High-density Lipoprotein-cholesterol concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Change in Hemoglobin A1c (HbA1c) concentration	Hemoglobin A1c (HbA1c) concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Change in C-reactive protein concentration	C-reactive protein concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Change in IL-6 concentration	IL-6 concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Change in TNF-alpha concentration	TNF-alpha concentration in the blood will be measured	Every 12 week (week 0 and week 12)
Change in gut microbiome composition	Gut microbiome composition in the fecal will be measured	Every 12 week (week 0 and week 12)
Change in short chain fatty acids concentration	Short chain fatty acids concentration in the fecal will be measured	Every 12 week (week 0 and week 12)
Change in bile acid concentration	Bile acid concentration in the fecal will be measured	Every 12 week (week 0 and week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in zonulin concentration	Zonulin concentration in the fecal will be measured	Every 12 week (week 0 and week 12)
Change in calprotectin levels	Calprotectin concentration in the fecal will be measured	Every 12 week (week 0 and week 12)
Change in appetite assessed by visual analogue scale	Visual analogue scale will be used to assess appetite.	Every 4 week (week 0, week 4, week 8 and week 12)
Change in sleep quality by questionnaire	Questionnaire will be used to assess sleep quality	Every 4 week (week 0, week 4, week 8 and week 12)
Change in weight and height	Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2	Every 4 week (week 0, week 4, week 8 and week 12)
Change in blood pressure	Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.	Every 4 week (week 0, week 4, week 8 and week 12)
Change in skin advanced glycation end products status	Skin advanced glycation end products status will be measured by a monitor.	Every 4 week (week 0, week 4, week 8 and week 12)
Change in dietary	Questionnaire will be used to record dietary	Every 4 week (week 0, week 4, week 8 and week 12)

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): October 28, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Estimated): 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: S20

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