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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulrika Gunnerud, Lund University
ClinicalTrials.gov Identifier:
NCT01586780
First received: April 23, 2012
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Satiety Response
Dietary Supplement: Protein drink
Dietary Supplement: Reference meal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of Pre-meal Drinks With Protein and Amino Acids on Glycemic and Metabolic Responses at a Subsequent Composite Meal

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Blood glucose, insulin, amino acids, ghrelin and incretins [ Time Frame: Acute postprandial phase (0-180 min) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective satiety [ Time Frame: 3h postprandial (0-180 min) ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reference meal Dietary Supplement: Reference meal
Control meal
Experimental: Whey protein Dietary Supplement: Protein drink
Test drink providing 9g protein
Experimental: Whey + 5 amino acids Dietary Supplement: Protein drink
Test drink providing 9g protein
Experimental: Whey + 6 amino acids Dietary Supplement: Protein drink
Test drink providing 9g protein
Experimental: Soy protein drink Dietary Supplement: Protein drink
Test drink providing 9g protein
Experimental: Soy + 5 amino acids Dietary Supplement: Protein drink
Test drink providing 9g protein
Experimental: Soy + 6 amino acids Dietary Supplement: Protein drink
Test drink providing 9g protein

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

Ages Eligible for Study:   20 Years to 28 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal fasting blood glucose
  • normal BMI

Exclusion Criteria:

  • smokers
  • vegetarians
  • subjects who receives any drug treatment
  • lactose malabsorption
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586780

Locations
Sweden
Applied Nutrition and Food Chemistry, Lund University
Lund, Sweden, SE-221 00
Sponsors and Collaborators
Lund University
Investigators
Study Chair: Inger Björck, Professor Lund University
Principal Investigator: Ulrika Gunnerud, MSc Lund University
  More Information

No publications provided by Lund University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulrika Gunnerud, Msc, Post Graduate student, Lund University
ClinicalTrials.gov Identifier: NCT01586780     History of Changes
Other Study ID Numbers: Dnr 1.556/2008
Study First Received: April 23, 2012
Last Updated: April 25, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University:
Whey protein
Soy protein
Insulinogenic amino acids
Incretins
Glycaemia
Insulinaemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014