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

November 7, 2023 updated by: Jung Eun Kim, National University of Singapore

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in blood glucose concentration
Time Frame: Every 12 week (week 0 and week 12)
Glucose concentration in the blood will be measured
Every 12 week (week 0 and week 12)
Change in insulin concentration
Time Frame: Every 12 week (week 0 and week 12)
Insulin concentration in the blood will be measured
Every 12 week (week 0 and week 12)
Change in blood triglyceride concentration
Time Frame: Every 12 week (week 0 and week 12)
Triglyceride concentration in the blood will be measured
Every 12 week (week 0 and week 12)
Change in blood cholesterol concentration
Time Frame: Every 12 week (week 0 and week 12)
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
Time Frame: Every 12 week (week 0 and week 12)
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
Time Frame: Every 12 week (week 0 and week 12)
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
Time Frame: Every 12 week (week 0 and week 12)
Hemoglobin A1c (HbA1c) concentration in the blood will be measured
Every 12 week (week 0 and week 12)
Change in C-reactive protein concentration
Time Frame: Every 12 week (week 0 and week 12)
C-reactive protein concentration in the blood will be measured
Every 12 week (week 0 and week 12)
Change in IL-6 concentration
Time Frame: Every 12 week (week 0 and week 12)
IL-6 concentration in the blood will be measured
Every 12 week (week 0 and week 12)
Change in TNF-alpha concentration
Time Frame: Every 12 week (week 0 and week 12)
TNF-alpha concentration in the blood will be measured
Every 12 week (week 0 and week 12)
Change in gut microbiome composition
Time Frame: Every 12 week (week 0 and week 12)
Gut microbiome composition in the fecal will be measured
Every 12 week (week 0 and week 12)
Change in short chain fatty acids concentration
Time Frame: Every 12 week (week 0 and week 12)
Short chain fatty acids concentration in the fecal will be measured
Every 12 week (week 0 and week 12)
Change in bile acid concentration
Time Frame: Every 12 week (week 0 and week 12)
Bile acid concentration in the fecal will be measured
Every 12 week (week 0 and week 12)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in zonulin concentration
Time Frame: Every 12 week (week 0 and week 12)
Zonulin concentration in the fecal will be measured
Every 12 week (week 0 and week 12)
Change in calprotectin levels
Time Frame: Every 12 week (week 0 and week 12)
Calprotectin concentration in the fecal will be measured
Every 12 week (week 0 and week 12)
Change in appetite assessed by visual analogue scale
Time Frame: Every 4 week (week 0, week 4, week 8 and week 12)
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
Time Frame: Every 4 week (week 0, week 4, week 8 and week 12)
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
Time Frame: Every 4 week (week 0, week 4, week 8 and week 12)
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
Time Frame: Every 4 week (week 0, week 4, week 8 and week 12)
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
Time Frame: Every 4 week (week 0, week 4, week 8 and week 12)
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
Time Frame: Every 4 week (week 0, week 4, week 8 and week 12)
Questionnaire will be used to record dietary
Every 4 week (week 0, week 4, week 8 and week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Singapore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Education, Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jung Eun Kim, Food Science and technology, Faculty of Science, National University of Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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