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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151188
• Other study ID #: 2014/00036
• Status: Completed
• Phase: N/A
• First received: May 28, 2014
• Last updated: February 1, 2016
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Glucose Intolerance
• Impaired Glucose Tolerance
• Obesity

Intervention

Dietary Supplement:
• Bread, Soy milk and cow milk
The study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals.

Device:
• real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3.5 hrs post consumption	No
Secondary	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.	2 hours post consumption	No