Pre DiabetesNCT03279107
Effects of Different Types of Carbohydrates in Snacks and Beverages on Glycemia, Insulinemia and Appetite.
A study testing Soluble corn fiber and maltodextrin in people with Pre Diabetes and Obesity, run by JeyaKumar Henry at 1 site in Singapore.
Trial summary
The aim of the study is to describe the glycemic, insulinemic and appetitive responses to liquid and solid foods where either soluble fiber or maltodextrin are used as the carbohydrate substrate. 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
- Pre Diabetes, Obesity
- What is being tested?
- Soluble corn fiber and maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Aug 2017to 21 Jul 2020
- 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
- Healthy Chinese male subjects aged between 21 and 60 years
- Either one of the three criteria:
- Normal weight (body mass index 18.5-22.9 kg/m2) and Fasting Blood Glucose 5.0-6.0mmol/L
- Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose 5.0-6.0mmol/L
- Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose <5.0mmol/L
Who cannot join
- Do smoke
- Have any metabolic diseases (such as diabetes, hypertension etc)
- Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Have medical conditions and/or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics)
- Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug
- Consume fiber supplements or other supplements that is likely to interfere with study outcomes
Show all 16Show fewer
- Have any severe food allergy (e.g. anaphylaxis to peanuts)
- Have any known allergies to any food components of the study protocol
- Have active Tuberculosis (TB) or currently receiving treatment for TB
- Have any known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
- Is a study team member or an immediate family of any study team member. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Is enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC.
- Partake in sports at the competitive and/or endurance levels
- Intentionally restrict food intake
- Have poor veins impeding venous access
- Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to describe the glycemic, insulinemic and appetitive responses to liquid and solid foods where either soluble fiber or maltodextrin are used as the carbohydrate substrate.
Read the detailed description
Asia has the unenviable reputation as being the epicenter for type 2 diabetes. The Asian phenotype has been shown to be most susceptible to diabetes than Caucasians. More importantly, the transition from prediabetes to diabetes is more drastic and severe in Asians. The glycemic index (GI) was first introduced in 1981 as a classification of the blood glucose raising potential of carbohydrate foods. There is substantial evidence suggesting that consumption of low glycemic index (GI) foods minimize blood glucose fluctuations, and help in the prevention and management of diabetes and prediabetes. Given the rising incidence of prediabetes and diabetes in Asia, dietary interventions to complement pharmacological management of diabetes are increasingly being encouraged. The majority of studies on GI and Glycemic Response (GR) have been conducted on Caucasian populations. Asians have been shown to have a greater GR to the same food compared to Caucasians. Simple dietary modification such as increasing dietary fiber in a food has been shown to reduce GR. However, it is unclear if a palatable, low-viscous, soluble fiber and maltodextrin have comparable effect. Although viscous insoluble fiber has been shown to also suppress appetite, it was unclear if similar effects could be obtained when it is replaced with soluble fiber. Using the continuous glucose monitoring system (CGMS), Henry and his colleagues have demonstrated that exchanging high-GI bread with a low-GI bread could improve the 24h glucose profile. More recently investigators have shown, using the CGMS, that the consumption of a low GI breakfast and afternoon snack was capable of attenuating 24-hour blood glucose profiles, minimizing glycemic excursions and reducing food intake in healthy Asian males. These simple dietary interventions appear to be an acceptable approach in improving overall glycemia and energy balance in Asians.
- Conditions
- Pre Diabetes, Obesity
- Being tested
- Soluble corn fiber, maltodextrin
- Medical subject headings
- Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble corn fiberOther
soluble corn fiber
maltodextrinOther
maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Control beverage with glucose powder | No intervention | Standard glucose beverage with 50 g of glucose powder |
| Beverage with soluble corn fiber | Experimental | Beverage with soluble corn fiber (50 gram of total carbohydrate) Receives: Other: Soluble corn fiber |
| Beverage with maltodextrin | Experimental | Beverage with maltodextrin (50 gram of total carbohydrate) Receives: Other: maltodextrin |
| Snack with soluble corn fiber | Experimental | snack with soluble corn fiber (50 gram of total carbohydrate) Receives: Other: Soluble corn fiber |
| Snack with maltodextrin | Experimental | Snack with maltodextrin (50 gram of total carbohydrate) Receives: Other: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma blood glucose from fasting baseline value (Time Frame: Up to 180 minutes).
Blood plasma glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.
Measured: up to 180 minutes
Change in plasma blood insulin from fasting baseline value (Time Frame: Up to 180 minutes).
Blood plasma insulin measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.
Measured: up to 180 minutes
Secondary outcomes (1)
Change in subjective appetite ratings from fasting baseline value (Time Frame: Up to 180 minutes).
Appetite ratings measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.
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 posted12 Sep 2017
- Study start25 Aug 2017
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies 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
- randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- JeyaKumar Henry
- Sponsor type
- Other government
- Collaborators
- Tate and Lyle Ingredients France
- Responsible party
- Sponsor-investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279107
- Sponsor's protocol ID
- 2017/00428
- Other IDs
- 2017
- Status last verified
- Aug 2021
- First submitted
- 6 Sep 2017
- Last updated
- 20 Aug 2021
- 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 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Types of Carbohydrates in Snacks and Beverages on Glycemia, Insulinemia and Appetite.
- ClinicalTrials.gov ID
- NCT03279107
- Acronym / sponsor ID
- 2017/00428
- Conditions
- Pre Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- JeyaKumar HenryOther government
- Collaborators
- Tate and Lyle Ingredients France
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 12 Sep 2017 (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 aim of the study is to describe the glycemic, insulinemic and appetitive responses to liquid and solid foods where either soluble fiber or maltodextrin are used as the carbohydrate substrate.
Detailed description
Asia has the unenviable reputation as being the epicenter for type 2 diabetes. The Asian phenotype has been shown to be most susceptible to diabetes than Caucasians. More importantly, the transition from prediabetes to diabetes is more drastic and severe in Asians. The glycemic index (GI) was first introduced in 1981 as a classification of the blood glucose raising potential of carbohydrate foods. There is substantial evidence suggesting that consumption of low glycemic index (GI) foods minimize blood glucose fluctuations, and help in the prevention and management of diabetes and prediabetes. Given the rising incidence of prediabetes and diabetes in Asia, dietary interventions to complement pharmacological management of diabetes are increasingly being encouraged. The majority of studies on GI and Glycemic Response (GR) have been conducted on Caucasian populations. Asians have been shown to have a greater GR to the same food compared to Caucasians. Simple dietary modification such as increasing dietary fiber in a food has been shown to reduce GR. However, it is unclear if a palatable, low-viscous, soluble fiber and maltodextrin have comparable effect. Although viscous insoluble fiber has been shown to also suppress appetite, it was unclear if similar effects could be obtained when it is replaced with soluble fiber. Using the continuous glucose monitoring system (CGMS), Henry and his colleagues have demonstrated that exchanging high-GI bread with a low-GI bread could improve the 24h glucose profile. More recently investigators have shown, using the CGMS, that the consumption of a low GI breakfast and afternoon snack was capable of attenuating 24-hour blood glucose profiles, minimizing glycemic excursions and reducing food intake in healthy Asian males. These simple dietary interventions appear to be an acceptable approach in improving overall glycemia and energy balance in Asians.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- randomized
| Arm | Type | Receives |
|---|---|---|
| Control beverage with glucose powder | No intervention | –Standard glucose beverage with 50 g of glucose powder |
| Beverage with soluble corn fiber | Experimental | Other: Soluble corn fiberBeverage with soluble corn fiber (50 gram of total carbohydrate) |
| Beverage with maltodextrin | Experimental | Other: maltodextrinBeverage with maltodextrin (50 gram of total carbohydrate) |
| Snack with soluble corn fiber | Experimental | Other: Soluble corn fibersnack with soluble corn fiber (50 gram of total carbohydrate) |
| Snack with maltodextrin | Experimental | Other: maltodextrinSnack with maltodextrin (50 gram of total carbohydrate) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Chinese male subjects aged between 21 and 60 years
- Either one of the three criteria:
- Normal weight (body mass index 18.5-22.9 kg/m2) and Fasting Blood Glucose 5.0-6.0mmol/L
- Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose 5.0-6.0mmol/L
- Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose <5.0mmol/L
Key exclusion criteria (16 listed)
- Do smoke
- Have any metabolic diseases (such as diabetes, hypertension etc)
- Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Have medical conditions and/or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics)
- Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug
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 |
|---|---|---|
| Soluble corn fibersoluble corn fiber | Other | Beverage with soluble corn fiber, Snack with soluble corn fiber |
| maltodextrinmaltodextrin | Other | Beverage with maltodextrin, Snack with maltodextrin |
Primary outcome
Change in plasma blood glucose from fasting baseline value (Time Frame: Up to 180 minutes).
Time frame: up to 180 minutes
Blood plasma glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.
Change in plasma blood insulin from fasting baseline value (Time Frame: Up to 180 minutes).
Time frame: up to 180 minutes
Blood plasma insulin measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.
1 secondary outcome
Change in subjective appetite ratings from fasting baseline value (Time Frame: Up to 180 minutes).
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 20 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Pre Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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 Soluble corn fiber and maltodextrin in people with Pre Diabetes and Obesity, run by JeyaKumar Henry 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 5 inclusion and 16 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 20 Aug 2021. 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?
Change in plasma blood glucose from fasting baseline value (Time Frame: Up to 180 minutes). (time frame: up to 180 minutes). The study lists 2 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 20 Aug 2021.