search
Back to results

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
Clinical Nutrition Research Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

21 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

First Posted
May 28, 2014
Last Updated
February 1, 2016
Sponsor
Clinical Nutrition Research Centre, Singapore
search

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

Learn more about this trial

Liquid Protein Preloads With Different Carbohydrate Types Effects on the Glycaemic and Insulinaemic Response

We'll reach out to this number within 24 hrs