NCT01034241

Brief Summary

The purpose of this study is to determine whether different protein diets affects glucose and insulin metabolism and substrate partitioning.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

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

April 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

December 16, 2009

Last Update Submit

August 21, 2018

Conditions

Keywords

milk proteinoverweightinsulin metabolismsubstrate partitioning

Outcome Measures

Primary Outcomes (1)

  • Glucose and insulin metabolism (24 h)

    24 h

Secondary Outcomes (1)

  • Substrate partitioning and metabolic markers

    24 h

Study Arms (4)

Control

EXPERIMENTAL

Diet consists of 15% dairy protein and low Glycemic Index (GI \< 40), 55 En% carbohydrates and 30 En% fat

Dietary Supplement: Control

High dairy protein

EXPERIMENTAL

Diet consists of 25% dairy protein and low GI (GI \< 40), 45 En% carbohydrates and 30 En% fat

Dietary Supplement: High dairy protein

vegetable protein

EXPERIMENTAL

Diet consists of 15 En% vegetable protein and low GI (GI \< 40), 55 En% carbohydrates and 30 En% fat

Dietary Supplement: vegetable protein

High GI

EXPERIMENTAL

Diet consists of 15 En% dairy protein and high GI(GI \> 60, 55 En% carbohydrates and 30 En% fat

Dietary Supplement: High GI

Interventions

ControlDIETARY_SUPPLEMENT

Diet consists of 15 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat

Control
High dairy proteinDIETARY_SUPPLEMENT

Diet consists of 25 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat

High dairy protein
vegetable proteinDIETARY_SUPPLEMENT

Diet consists of 15 En% vegetable protein and low GI, 55 En% carbohydrates and 30 En% fat

vegetable protein
High GIDIETARY_SUPPLEMENT

Diet consists of 15 En% dairy protein and high GI, 55 En% carbohydrates and 30 En% fat

High GI

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI: 18.5-25 kg/m2 (lean)
  • Gender: Male
  • Age: \<35 years
  • Caucasian

You may not qualify if:

  • Elevated fasting blood glucose level
  • Lactose intolerant
  • Diabetes Mellitus
  • Hypertension (systolic/diastolic blood pressure)
  • Hypotension (systolic/diastolic blood pressure)
  • Cardiovascular diseases
  • Asthma and other obstructive pulmonary diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Munsters MJ, Geraedts MC, Saris WH. Effects of different protein and glycemic index diets on metabolic profiles and substrate partitioning in lean healthy males. Appl Physiol Nutr Metab. 2013 Nov;38(11):1107-14. doi: 10.1139/apnm-2012-0409. Epub 2013 Apr 25.

MeSH Terms

Conditions

Insulin ResistanceOverweight

Interventions

Plant Proteins, Dietary

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Wim Saris, Prof. Dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

April 1, 2009

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

August 23, 2018

Record last verified: 2018-08