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Metabolic SyndromeNCT05529108

Glycaemic Control Effect of BSG and Underlying Gut - Related Mechanism 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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 85 years
Conditions the study is for
Metabolic Syndrome, Diabetes
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
38 participants
Where
1 siteSingapore
Study dates
28 Oct 2022to Sep 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.

Singapore1 site

  • NUS Department of Food Science & Technology

    Singapore, 117551

Other trials in Singapore

About this study

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

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.

Read the 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.

Being tested
control biscuits, autoclaved BSG-containing biscuits, bio-transformed BSG-containing 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.

  • control biscuitsDietary supplement

    Consumption of plain biscuits everyday during intervention period.

  • autoclaved BSG-containing biscuitsDietary supplement

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

  • bio-transformed BSG-containing biscuitsDietary supplement

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

Study groups in NCT05529108
Study groupRoleWhat they receive
Control biscuits groupPlacebo comparatorSubjects are required to consume 90 g control biscuits as their breakfast everyday during 12-week intervention period.
Receives: Dietary Supplement: control biscuits
autoclaved BSG-containing groupExperimentalSubjects are required to consume 90 g autoclaved BSG-containing biscuits as their breakfast everyday during 12-week intervention period.
Receives: Dietary Supplement: autoclaved BSG-containing biscuits
bio-transformed BSG-containing groupExperimentalSubjects are required to consume 90 g fermented BSG-containing biscuits as their breakfast everyday during 12-week intervention period.
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.

  1. Change in blood glucose concentration

    Glucose concentration in the blood will be measured

    Measured: Every 12 week (week 0 and week 12)

  2. Change in insulin concentration

    Insulin concentration in the blood will be measured

    Measured: Every 12 week (week 0 and week 12)

  3. Change in blood triglyceride concentration

    Triglyceride concentration in the blood will be measured

    Measured: Every 12 week (week 0 and week 12)

  4. Change in blood cholesterol concentration

    Total cholesterol concentration in the blood will be measured

    Measured: Every 12 week (week 0 and week 12)

  5. Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration

    Low-density Lipoprotein-cholesterol concentration in the blood will be measured

    Measured: Every 12 week (week 0 and week 12)

  6. Change in High-density Lipoprotein-cholesterol (HDL) concentration

    High-density Lipoprotein-cholesterol concentration in the blood will be measured

    Measured: Every 12 week (week 0 and week 12)

  7. Change in Hemoglobin A1c (HbA1c) concentration

    Hemoglobin A1c (HbA1c) concentration in the blood will be measured

    Measured: Every 12 week (week 0 and week 12)

  8. Change in C-reactive protein concentration

    C-reactive protein concentration in the blood will be measured

    Measured: Every 12 week (week 0 and week 12)

  9. Change in IL-6 concentration

    IL-6 concentration in the blood will be measured

    Measured: Every 12 week (week 0 and week 12)

  10. Change in TNF-alpha concentration

    TNF-alpha concentration in the blood will be measured

    Measured: Every 12 week (week 0 and week 12)

  11. Change in gut microbiome composition

    Gut microbiome composition in the fecal will be measured

    Measured: Every 12 week (week 0 and week 12)

  12. Change in short chain fatty acids concentration

    Short chain fatty acids concentration in the fecal will be measured

    Measured: Every 12 week (week 0 and week 12)

  13. Change in bile acid concentration

    Bile acid concentration in the fecal will be measured

    Measured: Every 12 week (week 0 and week 12)

Secondary outcomes (8)

  1. Change in zonulin concentration

    Zonulin concentration in the fecal will be measured

    Measured: Every 12 week (week 0 and week 12)

  2. Change in calprotectin levels

    Calprotectin concentration in the fecal will be measured

    Measured: Every 12 week (week 0 and week 12)

  3. Change in appetite assessed by visual analogue scale

    Visual analogue scale will be used to assess appetite.

    Measured: Every 4 week (week 0, week 4, week 8 and week 12)

  4. Change in sleep quality by questionnaire

    Questionnaire will be used to assess sleep quality

    Measured: Every 4 week (week 0, week 4, week 8 and week 12)

  5. Change in weight and height

    Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2

    Measured: Every 4 week (week 0, week 4, week 8 and week 12)

  6. Change in blood pressure

    Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.

    Measured: Every 4 week (week 0, week 4, week 8 and week 12)

  7. Change in skin advanced glycation end products status

    Skin advanced glycation end products status will be measured by a monitor.

    Measured: Every 4 week (week 0, week 4, week 8 and week 12)

  8. Change in dietary

    Questionnaire will be used to record dietary

    Measured: Every 4 week (week 0, week 4, week 8 and week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2022
  2. Study start28 Oct 2022
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05529108
Sponsor's protocol ID
S20
Status last verified
Nov 2023
First submitted
1 Sep 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.

Publications

  • Xu Y, Leong ZN, Huang Y, Ma Z, Chan GCT, Kim JE. Impact of brewer's spent grain (BSG) and bio-transformed BSG biscuits on metabolic and gut health in adults with metabolic impairments: a randomized controlled trial. Eur J Nutr. 2026 Apr 6;65(3):113. doi: 10.1007/s00394-026-03952-6.

    PubMed 41940993

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 12 week (week 0 and week 12)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05529108, which also lists 1 linked publication.

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.

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