Metabolic SyndromeNCT05421780
Post-prandial Glycaemic Controlling Effects of BSG in Singapore Adults With Metabolic Syndrome
A study testing autoclaved BSG-containing biscuits and bio-transformed BSG-containing biscuits in people with Metabolic Syndrome and Diabetes, run by National University of Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Metabolic Syndrome, Diabetes, Diet Modification
- What is being tested?
- autoclaved BSG-containing biscuits and bio-transformed BSG-containing biscuits
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Jun 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Brewer's Spent Grain (BSG) and Bio-transformed BSG Biscuits on Post-prandial Glycaemic Controlling Effects in Singapore Adults With Metabolic Syndrome
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.
Read the 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
- Being tested
- autoclaved BSG-containing biscuits, bio-transformed BSG-containing biscuits, control biscuits
- Keywords
- Metabolic Syndrome, middle-aged and older adults, Post-prandial Glycaemic response, bio-transformed food
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autoclaved BSG-containing biscuitsDietary supplement
Consumption of autoclaved BSG-containing biscuits as breakfast.
bio-transformed BSG-containing biscuitsDietary supplement
Consumption of bio-transformed BSG-containing biscuits as breakfast.
control biscuitsDietary supplement
Consumption of plain biscuits as breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Control biscuits group | Placebo comparator | For each MTT, subjects are to consume 90 g control biscuits as their breakfast within 15 mins. Receives: Dietary Supplement: control biscuits |
| autoclaved BSG-containing group | Experimental | For each MTT, subjects are to consume 90 g autoclaved BSG-containing biscuits as their breakfast within 15 mins. Receives: Dietary Supplement: autoclaved BSG-containing biscuits |
| bio-transformed BSG-containing group | Experimental | For each MTT, subjects are to consume 90 g bio-transformed BSG-containing biscuits as their breakfast within 15 mins. Receives: Dietary Supplement: bio-transformed BSG-containing biscuits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose concentration
Glucose concentration in the blood will be measured
Measured: Every week (week 1, week 2 and week 3)
Change in blood insulin concentration
Insulin concentration in the blood will be measured
Measured: Every week (week 1, week 2 and week 3)
Change in blood triglyceride concentration
Triglyceride concentration in the blood will be measured
Measured: Every week (week 1, week 2 and week 3)
Change in blood cholesterol concentration
Total cholesterol concentration in the blood will be measured
Measured: Every week (week 1, week 2 and week 3)
Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration
Low-density Lipoprotein-cholesterol concentration in the blood will be measured
Measured: Every week (week 1, week 2 and week 3)
Change in High-density Lipoprotein-cholesterol (HDL) concentration
High-density Lipoprotein-cholesterol concentration in the blood will be measured
Measured: Every week (week 1, week 2 and week 3)
Change in blood amino acid concentration
Amino acid concentration in the blood will be measured
Measured: Every week (week 1, week 2 and week 3)
Secondary outcomes (5)
Change in appetite assessed by visual analogue scale
Visual analogue scale will be used to assess appetite.
Measured: Every week (week 1, week 2 and week 3)
Change in breath CH4 and H2 concentrations
CH4 and H2 concentrations will be measured by breath analyzer
Measured: Every week (week 1, week 2 and week 3)
Change in weight and height
Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
Measured: Every week (week 1, week 2 and week 3)
Change in waist circumference
Waist circumference (in cm) will be measured
Measured: Every week (week 1, week 2 and week 3)
Change in blood pressure
Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.
Measured: Every week (week 1, week 2 and week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start29 Jun 2022
- Primary completion13 Dec 2022
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Responsible party
- Principal investigator, Jung Eun Kim, National University of Singapore
- Investigators
- Jung Eun Kim, Principal investigator, Food Science and technology, Faculty of Science, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421780
- Sponsor's protocol ID
- S16
- Status last verified
- Nov 2023
- First submitted
- 30 May 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Brewer's Spent Grain (BSG) and Bio-transformed BSG Biscuits on Post-prandial Glycaemic Controlling Effects in Singapore Adults With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT05421780
- Acronym / sponsor ID
- S16
- Conditions
- Metabolic Syndrome, Diabetes, Diet Modification
- Keywords
- Metabolic Syndrome, middle-aged and older adults, Post-prandial Glycaemic response, bio-transformed food
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- Jul 2024 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control biscuits group | Placebo comparator | Dietary Supplement: control biscuitsFor each MTT, subjects are to consume 90 g control biscuits as their breakfast within 15 mins. |
| autoclaved BSG-containing group | Experimental | Dietary Supplement: autoclaved BSG-containing biscuitsFor each MTT, subjects are to consume 90 g autoclaved BSG-containing biscuits as their breakfast within 15 mins. |
| bio-transformed BSG-containing group | Experimental | Dietary Supplement: bio-transformed BSG-containing biscuitsFor each MTT, subjects are to consume 90 g bio-transformed BSG-containing biscuits as their breakfast within 15 mins. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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);
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autoclaved BSG-containing biscuitsConsumption of autoclaved BSG-containing biscuits as breakfast. | Dietary supplement | autoclaved BSG-containing group |
| bio-transformed BSG-containing biscuitsConsumption of bio-transformed BSG-containing biscuits as breakfast. | Dietary supplement | bio-transformed BSG-containing group |
| control biscuitsConsumption of plain biscuits as breakfast. | Dietary supplement | Control biscuits group |
Primary outcome
Change in blood glucose concentration
Time frame: Every week (week 1, week 2 and week 3)
Glucose concentration in the blood will be measured
Change in blood insulin concentration
Time frame: Every week (week 1, week 2 and week 3)
Insulin concentration in the blood will be measured
Change in blood triglyceride concentration
Time frame: Every week (week 1, week 2 and week 3)
Triglyceride concentration in the blood will be measured
Change in blood cholesterol concentration
Time frame: Every week (week 1, week 2 and week 3)
Total cholesterol concentration in the blood will be measured
Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration
Time frame: Every week (week 1, week 2 and week 3)
Low-density Lipoprotein-cholesterol concentration in the blood will be measured
Change in High-density Lipoprotein-cholesterol (HDL) concentration
Time frame: Every week (week 1, week 2 and week 3)
High-density Lipoprotein-cholesterol concentration in the blood will be measured
Change in blood amino acid concentration
Time frame: Every week (week 1, week 2 and week 3)
Amino acid concentration in the blood will be measured
5 secondary outcomes
Change in appetite assessed by visual analogue scale
Time frame: Every week (week 1, week 2 and week 3)
Change in breath CH4 and H2 concentrations
Time frame: Every week (week 1, week 2 and week 3)
Change in weight and height
Time frame: Every week (week 1, week 2 and week 3)
Change in waist circumference
Time frame: Every week (week 1, week 2 and week 3)
Change in blood pressure
Time frame: Every week (week 1, week 2 and week 3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No. 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.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Eun Kim principal investigator
Food Science and technology, Faculty of Science, National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autoclaved BSG-containing biscuits and bio-transformed BSG-containing biscuits in people with Metabolic Syndrome and Diabetes, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood glucose concentration (time frame: Every week (week 1, week 2 and week 3)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.