Back to resultsGlycaemic Control Effect of BSG and Underlying Gut - Related Mechanism in Singapore Adults With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome, Diabetes
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
control biscuits
autoclaved BSG-containing biscuits
bio-transformed BSG-containing biscuits
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, middle-aged and older adults, Post-prandial Glycaemic response, bio-transformed food
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control biscuits group
autoclaved BSG-containing group
bio-transformed BSG-containing group
Arm Description
Subjects are required to consume 90 g control biscuits as their breakfast everyday during 12-week intervention period.
Subjects are required to consume 90 g autoclaved BSG-containing biscuits as their breakfast everyday during 12-week intervention period.
Subjects are required to consume 90 g fermented BSG-containing biscuits as their breakfast everyday during 12-week intervention period.
Outcomes
Primary Outcome Measures
Change in blood glucose concentration
Glucose concentration in the blood will be measured
Change in insulin concentration
Insulin concentration in the blood will be measured
Change in blood triglyceride concentration
Triglyceride concentration in the blood will be measured
Change in blood cholesterol concentration
Total cholesterol concentration in the blood will be measured
Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration
Low-density Lipoprotein-cholesterol concentration in the blood will be measured
Change in High-density Lipoprotein-cholesterol (HDL) concentration
High-density Lipoprotein-cholesterol concentration in the blood will be measured
Change in Hemoglobin A1c (HbA1c) concentration
Hemoglobin A1c (HbA1c) concentration in the blood will be measured
Change in C-reactive protein concentration
C-reactive protein concentration in the blood will be measured
Change in IL-6 concentration
IL-6 concentration in the blood will be measured
Change in TNF-alpha concentration
TNF-alpha concentration in the blood will be measured
Change in gut microbiome composition
Gut microbiome composition in the fecal will be measured
Change in short chain fatty acids concentration
Short chain fatty acids concentration in the fecal will be measured
Change in bile acid concentration
Bile acid concentration in the fecal will be measured
Secondary Outcome Measures
Change in zonulin concentration
Zonulin concentration in the fecal will be measured
Change in calprotectin levels
Calprotectin concentration in the fecal will be measured
Change in appetite assessed by visual analogue scale
Visual analogue scale will be used to assess appetite.
Change in sleep quality by questionnaire
Questionnaire will be used to assess sleep quality
Change in weight and height
Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
Change in blood pressure
Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.
Change in skin advanced glycation end products status
Skin advanced glycation end products status will be measured by a monitor.
Change in dietary
Questionnaire will be used to record dietary
Full Information
NCT ID
NCT05529108
First Posted
September 1, 2022
Last Updated
September 4, 2022
Sponsor
National University of Singapore
Collaborators
Ministry of Education, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT05529108
Brief Title
Glycaemic Control Effect of BSG and Underlying Gut - Related Mechanism in Singapore Adults With Metabolic Syndrome
Official Title
Impact of Brewer's Spent Grain (BSG) and Bio-transformed BSG Biscuits on Glycaemic Control and Gut Health in Singapore Adults With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
Ministry of Education, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Diabetes
Keywords
Metabolic Syndrome, middle-aged and older adults, Post-prandial Glycaemic response, bio-transformed food
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control biscuits group
Arm Type
Placebo Comparator
Arm Description
Subjects are required to consume 90 g control biscuits as their breakfast everyday during 12-week intervention period.
Arm Title
autoclaved BSG-containing group
Arm Type
Experimental
Arm Description
Subjects are required to consume 90 g autoclaved BSG-containing biscuits as their breakfast everyday during 12-week intervention period.
Arm Title
bio-transformed BSG-containing group
Arm Type
Experimental
Arm Description
Subjects are required to consume 90 g fermented BSG-containing biscuits as their breakfast everyday during 12-week intervention period.
Intervention Type
Dietary Supplement
Intervention Name(s)
control biscuits
Intervention Description
Consumption of plain biscuits everyday during intervention period.
Intervention Type
Dietary Supplement
Intervention Name(s)
autoclaved BSG-containing biscuits
Intervention Description
Consumption of autoclaved BSG-containing biscuits everyday during intervention period.
Intervention Type
Dietary Supplement
Intervention Name(s)
bio-transformed BSG-containing biscuits
Intervention Description
Consumption of bio-transformed BSG-containing biscuits everyday during intervention period.
Primary Outcome Measure Information:
Title
Change in blood glucose concentration
Description
Glucose concentration in the blood will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in insulin concentration
Description
Insulin concentration in the blood will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in blood triglyceride concentration
Description
Triglyceride concentration in the blood will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in blood cholesterol concentration
Description
Total cholesterol concentration in the blood will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration
Description
Low-density Lipoprotein-cholesterol concentration in the blood will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in High-density Lipoprotein-cholesterol (HDL) concentration
Description
High-density Lipoprotein-cholesterol concentration in the blood will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in Hemoglobin A1c (HbA1c) concentration
Description
Hemoglobin A1c (HbA1c) concentration in the blood will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in C-reactive protein concentration
Description
C-reactive protein concentration in the blood will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in IL-6 concentration
Description
IL-6 concentration in the blood will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in TNF-alpha concentration
Description
TNF-alpha concentration in the blood will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in gut microbiome composition
Description
Gut microbiome composition in the fecal will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in short chain fatty acids concentration
Description
Short chain fatty acids concentration in the fecal will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in bile acid concentration
Description
Bile acid concentration in the fecal will be measured
Time Frame
Every 12 week (week 0 and week 12)
Secondary Outcome Measure Information:
Title
Change in zonulin concentration
Description
Zonulin concentration in the fecal will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in calprotectin levels
Description
Calprotectin concentration in the fecal will be measured
Time Frame
Every 12 week (week 0 and week 12)
Title
Change in appetite assessed by visual analogue scale
Description
Visual analogue scale will be used to assess appetite.
Time Frame
Every 4 week (week 0, week 4, week 8 and week 12)
Title
Change in sleep quality by questionnaire
Description
Questionnaire will be used to assess sleep quality
Time Frame
Every 4 week (week 0, week 4, week 8 and week 12)
Title
Change in weight and height
Description
Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
Time Frame
Every 4 week (week 0, week 4, week 8 and week 12)
Title
Change in blood pressure
Description
Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.
Time Frame
Every 4 week (week 0, week 4, week 8 and week 12)
Title
Change in skin advanced glycation end products status
Description
Skin advanced glycation end products status will be measured by a monitor.
Time Frame
Every 4 week (week 0, week 4, week 8 and week 12)
Title
Change in dietary
Description
Questionnaire will be used to record dietary
Time Frame
Every 4 week (week 0, week 4, week 8 and week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yujing xu
Phone
98853979
Email
e0554129@u.nus.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Eun Kim
Organizational Affiliation
Food Science and technology, Faculty of Science, National University of Singapore
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Glycaemic Control Effect of BSG and Underlying Gut - Related Mechanism in Singapore Adults With Metabolic Syndrome
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