NCT01586780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

4 months

First QC Date

April 23, 2012

Last Update Submit

April 25, 2012

Conditions

Diabetes Mellitus, Type 2Satiety Response

Keywords

Whey proteinSoy proteinInsulinogenic amino acidsIncretinsGlycaemiaInsulinaemia

Outcome Measures

Primary Outcomes (1)

  • Blood glucose, insulin, amino acids, ghrelin and incretins

    Acute postprandial phase (0-180 min)

Secondary Outcomes (1)

  • Subjective satiety

    3h postprandial (0-180 min)

Study Arms (7)

Reference meal

EXPERIMENTAL
Dietary Supplement: Reference meal

Whey protein

EXPERIMENTAL
Dietary Supplement: Protein drink

Whey + 5 amino acids

EXPERIMENTAL
Dietary Supplement: Protein drink

Whey + 6 amino acids

EXPERIMENTAL
Dietary Supplement: Protein drink

Soy protein drink

EXPERIMENTAL
Dietary Supplement: Protein drink

Soy + 5 amino acids

EXPERIMENTAL
Dietary Supplement: Protein drink

Soy + 6 amino acids

EXPERIMENTAL
Dietary Supplement: Protein drink

Interventions

Protein drinkDIETARY_SUPPLEMENT

Test drink providing 9g protein

Soy + 5 amino acidsSoy + 6 amino acidsSoy protein drinkWhey + 5 amino acidsWhey + 6 amino acidsWhey protein
Reference mealDIETARY_SUPPLEMENT

Control meal

Reference meal

Eligibility Criteria

Age20 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal fasting blood glucose
  • normal BMI

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Nutrition and Food Chemistry, Lund University

Lund, SE-221 00, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 23028596DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Inger Björck, Professor

    Lund University

    STUDY CHAIR

  • Ulrika Gunnerud, MSc

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc, Post Graduate student

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 27, 2012

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

SE(1)