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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Satiety Response
• Interventions: Dietary Supplement: Reference meal; Dietary Supplement: Protein drink

• Registration Number: NCT01586780
• Lead Sponsor: Lund University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-04
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-25
• Last Update Submitted: 2012-04-25
• Study First Posted: 2012-04-27
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• normal fasting blood glucose
• normal BMI

Exclusion Criteria

• smokers
• vegetarians
• subjects who receives any drug treatment
• lactose malabsorption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference meal	Reference meal	-
Whey protein	Protein drink	-
Whey + 5 amino acids	Protein drink	-
Whey + 6 amino acids	Protein drink	-
Soy protein drink	Protein drink	-
Soy + 5 amino acids	Protein drink	-
Soy + 6 amino acids	Protein drink	-

Primary Outcome Measures

Name	Time	Method
Blood glucose, insulin, amino acids, ghrelin and incretins	Acute postprandial phase (0-180 min)

Secondary Outcome Measures

Name	Time	Method
Subjective satiety	3h postprandial (0-180 min)

Trial Locations

Locations (1)

Applied Nutrition and Food Chemistry, Lund University; 🇸🇪 Lund, Sweden