Clinical trial NCT01586780: Metabolic Effects of a Pre-meal Protein Drink With or Without Added Amino Acids at a Subsequent Composite Meal
Official title: Effects of Pre-meal Drinks With Protein and Amino Acids on Glycemic and Metabolic Responses at a Subsequent Composite Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Satiety Response
Keywords: Whey protein
Soy protein
Insulinogenic amino acids
Incretins
Glycaemia
Insulinaemia
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* normal fasting blood glucose
* normal BMI

Exclusion Criteria:

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

Primary outcomes:
measure: Blood glucose, insulin, amino acids, ghrelin and incretins
timeFrame: Acute postprandial phase (0-180 min)
Secondary outcomes:
measure: Subjective satiety
timeFrame: 3h postprandial (0-180 min)
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Applied Nutrition and Food Chemistry, Lund University
Study officials:
affiliation: Lund University
name: Inger Björck, Professor
role: STUDY_CHAIR
affiliation: Lund University
name: Ulrika Gunnerud, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gunnerud UJ, Heinzle C, Holst JJ, Ostman EM, Bjorck IM. Effects of pre-meal drinks with protein and amino acids on glycemic and metabolic responses at a subsequent composite meal. PLoS One. 2012;7(9):e44731. doi: 10.1371/journal.pone.0044731. Epub 2012 Sep 19.