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

NCT ID: NCT01586780

Last Updated: 2012-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Satiety Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Reference meal

Group Type EXPERIMENTAL

Reference meal

Intervention Type DIETARY_SUPPLEMENT

Control meal

Whey protein

Group Type EXPERIMENTAL

Protein drink

Intervention Type DIETARY_SUPPLEMENT

Test drink providing 9g protein

Whey + 5 amino acids

Group Type EXPERIMENTAL

Protein drink

Intervention Type DIETARY_SUPPLEMENT

Test drink providing 9g protein

Whey + 6 amino acids

Group Type EXPERIMENTAL

Protein drink

Intervention Type DIETARY_SUPPLEMENT

Test drink providing 9g protein

Soy protein drink

Group Type EXPERIMENTAL

Protein drink

Intervention Type DIETARY_SUPPLEMENT

Test drink providing 9g protein

Soy + 5 amino acids

Group Type EXPERIMENTAL

Protein drink

Intervention Type DIETARY_SUPPLEMENT

Test drink providing 9g protein

Soy + 6 amino acids

Group Type EXPERIMENTAL

Protein drink

Intervention Type DIETARY_SUPPLEMENT

Test drink providing 9g protein

Interventions

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Protein drink

Test drink providing 9g protein

Intervention Type DIETARY_SUPPLEMENT

Reference meal

Control meal

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* normal fasting blood glucose
* normal BMI

Exclusion Criteria

* smokers
* vegetarians
* subjects who receives any drug treatment
* lactose malabsorption
Minimum Eligible Age

20 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Ulrika Gunnerud

Msc, Post Graduate student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Inger Björck, Professor

Role: STUDY_CHAIR

Lund University

Ulrika Gunnerud, MSc

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Applied Nutrition and Food Chemistry, Lund University

Lund, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 23028596 (View on PubMed)

Other Identifiers

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Dnr 1.556/2008

Identifier Type: -

Identifier Source: org_study_id

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