DiabetesNCT02151188
Liquid Protein Preloads With Different Carbohydrate Types Effects on the Glycaemic and Insulinaemic Response
A study testing Bread, Soy milk and cow milk and real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC) in people with Diabetes and Impaired Glucose Tolerance, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
This study hypothesizes that milk protein consumed together or shortly before a white rice or white bread carbohydrate meal exerts different influence on the glycaemic, insulinaemic responses. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Impaired Glucose Tolerance, Obesity
- What is being tested?
- Bread, Soy milk and cow milk and real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2014to Oct 2015
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese ethnicity
- Age between 21-40 years
- Not on prescription medication known to affect glucose and satiety related metabolism
- Do not partake in sports at the competitive and/or endurance levels
- Weight of at least 45kg
- Body mass index between 18.0 to 24.9 kg/m2
- Normal blood pressure (120/80 mmHg)
Who cannot join
- fasting blood glucose>5.5 mmol/L
- Any major medical conditions including diabetes, hypertension, cardiovascular disease, thyroid disorders
- Allergic or intolerant to foods presented in the study
Trial locations and contacts
1 site in 1 country.
About this study
This study hypothesizes that milk protein consumed together or shortly before a white rice or white bread carbohydrate meal exerts different influence on the glycaemic, insulinaemic responses.
Read the detailed description
Consumption of milk proteins increase satiety and reduce glucose response when consumed alone or with carbohydrate. Milk proteins are of interest because proteins are more satiating than either carbohydrate or fat, and they regulate food intake and metabolic functions by the intact protein, encrypted peptides and amino acids on gastrointestinal and central pathways. White rice and white bread are two common carbohydrates types mostly consumed in Asia. Both of them are known to result in high glycaemic and insulinaemic responses. However, in most meals, they are accompanied by other foods such as soy milk, cow milk products. The glyceamic and insulinaemic responses are determined by the type of protein and the type of carbohydrates. And also the consumption time of protein and carbohydrate. Recent research points to an intrinsic value of small amounts of milk protein or dairy consumed shortly before a meal can reduce the glycemic response to carbohydrate and that this is not at the cost of increased demand for insulin. The objective of the present study is to investigate how glycaemic, insulinaemic and satiety responses to a white rice or white bread meal changed when a soy milk or cow milk consumed together or shortly before the meal. Whole soy milk and whole cow milk will be added to the meal. Healthy subjects (n 15) will ingest the test meals once. The meals will be provided as breakfasts, on 10 different occasions, in random order with ≥ 7 days between each. Blood samples (from the cannula and finger pricks) will be then drawn for 3 h, and glucose and serum insulin, plasma glucagon, satiety markers, inflammation markers, amino acids et.al will be analysed. The objective of the study is determining if different liquid protein consumed shortly before or with carbohydrate has different effects on metabolism. And also we will compare the difference of white rice and white bread. Determining the consuming time effect, milk protein type and carbohydrate type on glycaemic and insulinaemic are critical for the provision of dietary advice and formulation of public health guidelines.
- Conditions
- Diabetes, Impaired Glucose Tolerance, Obesity
- Being tested
- Bread, Soy milk and cow milk, real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bread, Soy milk and cow milkDietary supplement
The study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals.
real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)Device
| Study group | Role | What they receive |
|---|---|---|
| Bread and water | Other | co-ingestion control session Receives: Dietary Supplement: Bread, Soy milk and cow milk; Device: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC) |
| bread with cow milk co-ingestion | Experimental | co-ingestion bread with cow milk Receives: Dietary Supplement: Bread, Soy milk and cow milk; Device: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC) |
| bread with soy milk co-ingestion | Experimental | co-ingestion bread with soy milk Receives: Dietary Supplement: Bread, Soy milk and cow milk; Device: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC) |
| preload cow milk | Experimental | preload cow milk 30 min, then bread Receives: Dietary Supplement: Bread, Soy milk and cow milk; Device: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC) |
| preload soy milk | Experimental | preload soy milk 30 min, then bread Receives: Dietary Supplement: Bread, Soy milk and cow milk; Device: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose response of different treatments
The blood glucose will be measured by Hemocue 201 from finger prick. Venous blood will be collected at the same time points.
Measured: 3.5 hrs post consumption
Secondary outcomes (1)
Gastric emptying rate
Measurement of gastric emptying rate using real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC). Ultrasound measurements will be taken with subjects in a supine position during fasting, then at 15-30 min intervals after consumption of the test meal.
Measured: 2 hours post consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Melvin Leow, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151188
- Sponsor's protocol ID
- 2014/00036
- Other IDs
- 2014
- Status last verified
- Feb 2016
- First submitted
- 28 May 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sun L, Tan KWJ, Han CMS, Leow MK, Henry CJ. Impact of preloading either dairy or soy milk on postprandial glycemia, insulinemia and gastric emptying in healthy adults. Eur J Nutr. 2017 Feb;56(1):77-87. doi: 10.1007/s00394-015-1059-y. Epub 2015 Oct 6.
PubMed 26439722
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Protein Preloads With Different Carbohydrate Types Effects on the Glycaemic and Insulinaemic Response
- ClinicalTrials.gov ID
- NCT02151188
- Acronym / sponsor ID
- 2014/00036
- Conditions
- Diabetes, Impaired Glucose Tolerance, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 May 2014 (estimated)
- 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.
This study hypothesizes that milk protein consumed together or shortly before a white rice or white bread carbohydrate meal exerts different influence on the glycaemic, insulinaemic responses.
Detailed description
Consumption of milk proteins increase satiety and reduce glucose response when consumed alone or with carbohydrate. Milk proteins are of interest because proteins are more satiating than either carbohydrate or fat, and they regulate food intake and metabolic functions by the intact protein, encrypted peptides and amino acids on gastrointestinal and central pathways. White rice and white bread are two common carbohydrates types mostly consumed in Asia. Both of them are known to result in high glycaemic and insulinaemic responses. However, in most meals, they are accompanied by other foods such as soy milk, cow milk products. The glyceamic and insulinaemic responses are determined by the type of protein and the type of carbohydrates. And also the consumption time of protein and carbohydrate. Recent research points to an intrinsic value of small amounts of milk protein or dairy consumed shortly before a meal can reduce the glycemic response to carbohydrate and that this is not at the cost of increased demand for insulin. The objective of the present study is to investigate how glycaemic, insulinaemic and satiety responses to a white rice or white bread meal changed when a soy milk or cow milk consumed together or shortly before the meal. Whole soy milk and whole cow milk will be added to the meal. Healthy subjects (n 15) will ingest the test meals once. The meals will be provided as breakfasts, on 10 different occasions, in random order with ≥ 7 days between each. Blood samples (from the cannula and finger pricks) will be then drawn for 3 h, and glucose and serum insulin, plasma glucagon, satiety markers, inflammation markers, amino acids et.al will be analysed. The objective of the study is determining if different liquid protein consumed shortly before or with carbohydrate has different effects on metabolism. And also we will compare the difference of white rice and white bread. Determining the consuming time effect, milk protein type and carbohydrate type on glycaemic and insulinaemic are critical for the provision of dietary advice and formulation of public health guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Bread and water | Other | Dietary Supplement: Bread, Soy milk and cow milk, Device: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)co-ingestion control session |
| bread with cow milk co-ingestion | Experimental | Dietary Supplement: Bread, Soy milk and cow milk, Device: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)co-ingestion bread with cow milk |
| bread with soy milk co-ingestion | Experimental | Dietary Supplement: Bread, Soy milk and cow milk, Device: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)co-ingestion bread with soy milk |
| preload cow milk | Experimental | Dietary Supplement: Bread, Soy milk and cow milk, Device: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)preload cow milk 30 min, then bread |
| preload soy milk | Experimental | Dietary Supplement: Bread, Soy milk and cow milk, Device: real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)preload soy milk 30 min, then bread |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Chinese ethnicity
- Age between 21-40 years
- Not on prescription medication known to affect glucose and satiety related metabolism
- Do not partake in sports at the competitive and/or endurance levels
- Weight of at least 45kg
Key exclusion criteria (3 listed)
- fasting blood glucose>5.5 mmol/L
- Any major medical conditions including diabetes, hypertension, cardiovascular disease, thyroid disorders
- Allergic or intolerant to foods presented in the study
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 |
|---|---|---|
| Bread, Soy milk and cow milkThe study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals. | Dietary supplement | Bread and water, bread with cow milk co-ingestion, bread with soy milk co-ingestion, preload cow milk, preload soy milk |
| real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC) | Device | Bread and water, bread with cow milk co-ingestion, bread with soy milk co-ingestion, preload cow milk, preload soy milk |
Primary outcome
Glucose response of different treatments
Time frame: 3.5 hrs post consumption
The blood glucose will be measured by Hemocue 201 from finger prick. Venous blood will be collected at the same time points.
1 secondary outcome
Gastric emptying rate
Time frame: 2 hours post consumption
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 2 Feb 2016.
- Derived from this study: PubMed 26439722Sun L, Tan KWJ, Han CMS, Leow MK, Henry CJ. Impact of preloading either dairy or soy milk on postprandial glycemia, insulinemia and gastric emptying in healthy adults. Eur J Nutr. 2017 Feb;56(1):77-87. doi: 10.1007/s00394-015-1059-y. Epub 2015 Oct 6.
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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 Bread, Soy milk and cow milk and real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC) in people with Diabetes and Impaired Glucose Tolerance, 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 7 inclusion and 3 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 2 Feb 2016. 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 response of different treatments (time frame: 3.5 hrs post consumption). 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 NCT02151188, 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 2 Feb 2016.