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

April 25, 2012 updated by: Ulrika Gunnerud, Lund University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, SE-221 00
        • Applied Nutrition and Food Chemistry, Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 28 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • normal fasting blood glucose
  • normal BMI

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood glucose, insulin, amino acids, ghrelin and incretins
Time Frame: Acute postprandial phase (0-180 min)
Acute postprandial phase (0-180 min)

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective satiety
Time Frame: 3h postprandial (0-180 min)
3h postprandial (0-180 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Study Chair: Inger Björck, Professor, Lund University
  • Principal Investigator: Ulrika Gunnerud, MSc, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 25, 2012

First Posted (ESTIMATE)

April 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 1.556/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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