Metabolic Effects of a Pre-meal Protein Drink With or Without Added Amino Acids at a Subsequent Composite Meal
Primary Purpose
Diabetes Mellitus, Type 2, Satiety Response
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Protein drink
Reference meal
Sponsored by

About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Whey protein, Soy protein, Insulinogenic amino acids, Incretins, Glycaemia, Insulinaemia
Eligibility Criteria
Inclusion Criteria:
- normal fasting blood glucose
- normal BMI
Exclusion Criteria:
- smokers
- vegetarians
- subjects who receives any drug treatment
- lactose malabsorption
Sites / Locations
- Applied Nutrition and Food Chemistry, Lund University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Reference meal
Whey protein
Whey + 5 amino acids
Whey + 6 amino acids
Soy protein drink
Soy + 5 amino acids
Soy + 6 amino acids
Arm Description
Outcomes
Primary Outcome Measures
Blood glucose, insulin, amino acids, ghrelin and incretins
Secondary Outcome Measures
Subjective satiety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01586780
Brief Title
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
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Satiety Response
Keywords
Whey protein, Soy protein, Insulinogenic amino acids, Incretins, Glycaemia, Insulinaemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reference meal
Arm Type
Experimental
Arm Title
Whey protein
Arm Type
Experimental
Arm Title
Whey + 5 amino acids
Arm Type
Experimental
Arm Title
Whey + 6 amino acids
Arm Type
Experimental
Arm Title
Soy protein drink
Arm Type
Experimental
Arm Title
Soy + 5 amino acids
Arm Type
Experimental
Arm Title
Soy + 6 amino acids
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein drink
Intervention Description
Test drink providing 9g protein
Intervention Type
Dietary Supplement
Intervention Name(s)
Reference meal
Intervention Description
Control meal
Primary Outcome Measure Information:
Title
Blood glucose, insulin, amino acids, ghrelin and incretins
Time Frame
Acute postprandial phase (0-180 min)
Secondary Outcome Measure Information:
Title
Subjective satiety
Time Frame
3h postprandial (0-180 min)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
normal fasting blood glucose
normal BMI
Exclusion Criteria:
smokers
vegetarians
subjects who receives any drug treatment
lactose malabsorption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inger Björck, Professor
Organizational Affiliation
Lund University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ulrika Gunnerud, MSc
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Nutrition and Food Chemistry, Lund University
City
Lund
ZIP/Postal Code
SE-221 00
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
23028596
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.
Results Reference
derived
Learn more about this trial
Metabolic Effects of a Pre-meal Protein Drink With or Without Added Amino Acids at a Subsequent Composite Meal
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