Liquid Protein Preloads With Different Carbohydrate Types Effects on the Glycaemic and Insulinaemic Response
Primary Purpose
Diabetes, Impaired Glucose Tolerance, Obesity
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Bread, Soy milk and cow milk
real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria: Smoker
- 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
Sites / Locations
- Clinical Nutrition Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Experimental
Experimental
Experimental
Experimental
Arm Label
Bread and water
bread with cow milk co-ingestion
bread with soy milk co-ingestion
preload cow milk
preload soy milk
Arm Description
co-ingestion control session
co-ingestion bread with cow milk
co-ingestion bread with soy milk
preload cow milk 30 min, then bread
preload soy milk 30 min, then bread
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02151188
First Posted
May 28, 2014
Last Updated
February 1, 2016
Sponsor
Clinical Nutrition Research Centre, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02151188
Brief Title
Liquid Protein Preloads With Different Carbohydrate Types Effects on the Glycaemic and Insulinaemic Response
Official Title
Liquid Protein Preloads With Different Carbohydrate Types Effects on the Glycaemic and Insulinaemic Response
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Nutrition Research Centre, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Impaired Glucose Tolerance, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bread and water
Arm Type
Other
Arm Description
co-ingestion control session
Arm Title
bread with cow milk co-ingestion
Arm Type
Experimental
Arm Description
co-ingestion bread with cow milk
Arm Title
bread with soy milk co-ingestion
Arm Type
Experimental
Arm Description
co-ingestion bread with soy milk
Arm Title
preload cow milk
Arm Type
Experimental
Arm Description
preload cow milk 30 min, then bread
Arm Title
preload soy milk
Arm Type
Experimental
Arm Description
preload soy milk 30 min, then bread
Intervention Type
Dietary Supplement
Intervention Name(s)
Bread, Soy milk and cow milk
Intervention Description
The study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals.
Intervention Type
Device
Intervention Name(s)
real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)
Primary Outcome Measure Information:
Title
Glucose response of different treatments
Description
The blood glucose will be measured by Hemocue 201 from finger prick. Venous blood will be collected at the same time points.
Time Frame
3.5 hrs post consumption
Secondary Outcome Measure Information:
Title
Gastric emptying rate
Description
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.
Time Frame
2 hours post consumption
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria: Smoker
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
Facility Information:
Facility Name
Clinical Nutrition Research Centre
City
Singapore
ZIP/Postal Code
117599
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
26439722
Citation
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.
Results Reference
derived
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Liquid Protein Preloads With Different Carbohydrate Types Effects on the Glycaemic and Insulinaemic Response
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