Metabolic Effects of a Pre-meal Protein Drink With or Without Added Amino Acids at a Subsequent Composite Meal

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effects of Pre-meal Drinks With Protein and Amino Acids on Glycemic and Metabolic Responses at a Subsequent Composite Meal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586780
• Other study ID #: Dnr 1.556/2008
• Status: Completed
• Phase: N/A
• First received: April 23, 2012
• Last updated: April 25, 2012
• Start date: August 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2012
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study was to investigate the efficacy of intake of whey or soy protein isolates, respectively, with or without supplementation of amino acids, on post-meal insulin secretion and glycaemic regulation. Additionally, the effect on plasma amino acids, gut hormones and ghrelin in plasma, as well as subjective satiety was investigated.

Description:

Hyperglycaemia in type 2 diabetes (T2D) is associated with an increased risk of cardiovascular diseases, and it has been suggested that reduction of postprandial glycaemia is just as important as lowering fasting blood glucose levels to reach optimal metabolic control and reduce risk of complications in T2D. Observational studies indicate that milk consumption reduces the risk of developing T2D, obesity and cardiovascular disease, and a possible protective mechanism has been ascribed to the protein fraction. It has previously been demonstrated that addition of whey proteins, co-ingested with carbohydrates, stimulates insulin secretion and reduces postprandial glycaemia in both healthy subjects as well as in T2D patients. The effect is mediated through the insulinogenic properties of whey that appears to stem from a generation of a particular amino acid (AA) pattern in postprandial blood after ingestion of whey proteins. In the presently described project it is hypothesized that exchanging part of the whey protein for insulinogenic AA might be useful to optimize an insulinogenic effect. Additionally, soy protein has been suggested to have beneficial effects on insulin resistance and obesity as well on satiety. The possible effect of soy protein on insulin response and glycaemic regulation is therefore also of interest.

A randomized, single blind, within-subject trial was performed. The test meals were provided as breakfasts on 7 different occasions in random order with approximately 1 week between each test. The test subjects were instructed to drink the protein drink immediately prior to eating the standardized sandwich meal. Altogether, the protein drink and the sandwich meal were to be consumed within 12 min.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 28 Years

Eligibility

Inclusion Criteria:

• normal fasting blood glucose

• normal BMI

Exclusion Criteria:

• smokers

• vegetarians

• subjects who receives any drug treatment

• lactose malabsorption

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Satiety Response

Intervention

Dietary Supplement:
• Protein drink
Test drink providing 9g protein
• Reference meal
Control meal

Locations

Country	Name	City	State
Sweden	Applied Nutrition and Food Chemistry, Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose, insulin, amino acids, ghrelin and incretins		Acute postprandial phase (0-180 min)	No
Secondary	Subjective satiety		3h postprandial (0-180 min)	No