Diabetes Mellitus, Type 2GIFNCT03868683
The Glycemic Effect of Added Sugar on Bake Beans
A study testing Glucose Reference 1, Glucose Reference 2 and Glucose reference 3 in people with Diabetes Mellitus, Type 2 and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
To investigate the effect of added sugar to bake beans on glycemic and insulinemic response. Read more about this study
- Who is it for?
- Ages 21 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, PreDiabetes
- What is being tested?
- Glucose Reference 1, Glucose Reference 2 and Glucose reference 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Aug 2018to 17 Apr 2019
- 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 21 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese ethnicity
- Age ≥21 and ≤ 60 years
- Body mass index between 18.5 to 25 kg/m2
- Normal blood pressure <140/90 mmHg
- Fasting blood glucose <6.0 mmol/L
- In general good health
Who cannot join
- Current Smoker
- have any metabolic diseases (such as diabetes, hypertension etc)
- have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
- have intolerances or allergies to any foods
- partake in sports at the competitive and/or endurance levels
- intentionally restrict food intake
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of added sugar to bake beans on glycemic and insulinemic response.
Read the detailed description
There will be a total of 7 test session. Each session will last for 3 hours. At each test session, volunteers will be served with 7 test meals and blood will be collected. After an overnight fast, subjects will visit the research center. Two fasting capillary blood samples will be collected via fingerpick. Following the fasting samples, volunteers will consume the test meals. Further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180 minutes after the ingestion of test meal. These samples will be used to analyses for whole capillary blood glucose. At every 30 minute interval, samples will be collected for analysis of capillary plasma insulin.
- Conditions
- Diabetes Mellitus, Type 2, Obesity, PreDiabetes
- Being tested
- Glucose Reference 1, Glucose Reference 2, Glucose reference 3, Sucrose, Regular Bake beans in tomato sauce
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose Reference 1Other
30 g of glucose dissolved in 250 ml of water
Glucose Reference 2Other
30 g of glucose dissolved in 250 ml of water
Glucose reference 3Other
30 g of glucose dissolved in 250 ml of water
SucroseOther
30 g of Sucrose dissolved in 250 ml of water
Regular Bake beans in tomato sauceOther
Bake beans in tomato sauce containing 14 g of sugar
Bake beans in tomato sauce, reduced sugarOther
Bake beans in tomato sauce containing 12.2 g of sugar
Bake beans in tomato sauce, low GIOther
Bake beans in tomato sauce containing 7.2 g of sugar
| Study group | Role | What they receive |
|---|---|---|
| Glucose Reference 1 | Other | Glucose solution containing 30 g of glucose Receives: Other: Glucose Reference 1 |
| Glucose Reference 2 | Other | Glucose solution 2 containing 30 g of glucose Receives: Other: Glucose Reference 2 |
| Glucose Reference 3 | Other | Glucose solution 3 containing 30 g of glucose Receives: Other: Glucose reference 3 |
| Sucrose | Experimental | Sucrose solution containing 30 g of sucrose Receives: Other: Sucrose |
| Regular Bake beans in tomato sauce | Experimental | Bake bean in tomato sauce with high levels of sucrose (37%) Receives: Other: Regular Bake beans in tomato sauce |
| Bake beans in tomato sauce, reduced sugar | Experimental | Bake bean in tomato sauce with medium levels of sucrose (29.9%) Receives: Other: Bake beans in tomato sauce, reduced sugar |
| Bake beans in tomato sauce, low GI | Experimental | Bake bean in tomato sauce with low levels of sucrose (18.5%) Receives: Other: Bake beans in tomato sauce, low GI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose [
Whole capillary blood glucose will be measure using Hemocue analyser
Measured: Up to 180 minutes
Secondary outcomes (1)
Insulin
Capillary plasma will be measure using Cobas analyser
Measured: Up to 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start20 Aug 2018
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover randomized controlled Trials
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868683
- Sponsor's protocol ID
- 2016/00926
- Other IDs
- 2016
- Acronym
- GIF
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2019
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Glycemic Effect of Added Sugar on Bake Beans
- ClinicalTrials.gov ID
- NCT03868683
- Acronym / sponsor ID
- GIF / 2016/00926
- Conditions
- Diabetes Mellitus, Type 2, Obesity, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 11 Mar 2019 (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.
To investigate the effect of added sugar to bake beans on glycemic and insulinemic response.
Detailed description
There will be a total of 7 test session. Each session will last for 3 hours. At each test session, volunteers will be served with 7 test meals and blood will be collected. After an overnight fast, subjects will visit the research center. Two fasting capillary blood samples will be collected via fingerpick. Following the fasting samples, volunteers will consume the test meals. Further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180 minutes after the ingestion of test meal. These samples will be used to analyses for whole capillary blood glucose. At every 30 minute interval, samples will be collected for analysis of capillary plasma insulin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Crossover randomized controlled Trials
| Arm | Type | Receives |
|---|---|---|
| Glucose Reference 1 | Other | Other: Glucose Reference 1Glucose solution containing 30 g of glucose |
| Glucose Reference 2 | Other | Other: Glucose Reference 2Glucose solution 2 containing 30 g of glucose |
| Glucose Reference 3 | Other | Other: Glucose reference 3Glucose solution 3 containing 30 g of glucose |
| Sucrose | Experimental | Other: SucroseSucrose solution containing 30 g of sucrose |
| Regular Bake beans in tomato sauce | Experimental | Other: Regular Bake beans in tomato sauceBake bean in tomato sauce with high levels of sucrose (37%) |
| Bake beans in tomato sauce, reduced sugar | Experimental | Other: Bake beans in tomato sauce, reduced sugarBake bean in tomato sauce with medium levels of sucrose (29.9%) |
| Bake beans in tomato sauce, low GI | Experimental | Other: Bake beans in tomato sauce, low GIBake bean in tomato sauce with low levels of sucrose (18.5%) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chinese ethnicity
- Age ≥21 and ≤ 60 years
- Body mass index between 18.5 to 25 kg/m2
- Normal blood pressure <140/90 mmHg
- Fasting blood glucose <6.0 mmol/L
Key exclusion criteria (7 listed)
- Current Smoker
- have any metabolic diseases (such as diabetes, hypertension etc)
- have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
- have intolerances or allergies to any foods
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 |
|---|---|---|
| Glucose Reference 130 g of glucose dissolved in 250 ml of water | Other | Glucose Reference 1 |
| Glucose Reference 230 g of glucose dissolved in 250 ml of water | Other | Glucose Reference 2 |
| Glucose reference 330 g of glucose dissolved in 250 ml of water | Other | Glucose Reference 3 |
| Sucrose30 g of Sucrose dissolved in 250 ml of water | Other | Sucrose |
| Regular Bake beans in tomato sauceBake beans in tomato sauce containing 14 g of sugar | Other | Regular Bake beans in tomato sauce |
| Bake beans in tomato sauce, reduced sugarBake beans in tomato sauce containing 12.2 g of sugar | Other | Bake beans in tomato sauce, reduced sugar |
| Bake beans in tomato sauce, low GIBake beans in tomato sauce containing 7.2 g of sugar | Other | Bake beans in tomato sauce, low GI |
Primary outcome
Glucose [
Time frame: Up to 180 minutes
Whole capillary blood glucose will be measure using Hemocue analyser
1 secondary outcome
Insulin
Time frame: Up to 180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose Reference 1, Glucose Reference 2 and Glucose reference 3 in people with Diabetes Mellitus, Type 2 and Obesity, run by Singapore Institute of Food and Biotechnology Innovation 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 17 Jul 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glucose [ (time frame: Up to 180 minutes). 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 17 Jul 2020.