NCT01034293

Brief Summary

The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning.

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

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

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

October 1, 2009

Completed
3 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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 23, 2010

Status Verified

July 1, 2010

Enrollment Period

5 months

First QC Date

December 16, 2009

Last Update Submit

July 22, 2010

Conditions

InsulinGlucose Metabolism

Keywords

feeding frequencyinsulin metabolismglucose metabolismsubstrate partitioning

Outcome Measures

Primary Outcomes (1)

  • Glucose and insulin metabolism

    24 h

Secondary Outcomes (1)

  • Substrate partitioning and metabolic markers

    24 h

Study Arms (2)

low feeding frequency (3x)

EXPERIMENTAL
Dietary Supplement: low feeding frequency (3x)

High feeding frequency (14x)

EXPERIMENTAL
Dietary Supplement: High feeding frequency (14x)

Interventions

low feeding frequency (3x)DIETARY_SUPPLEMENT

3 meals a day

low feeding frequency (3x)
High feeding frequency (14x)DIETARY_SUPPLEMENT

14 meals a day

High feeding frequency (14x)

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: subjects has to be older than 18 and including 35 years old
  • Caucasian

You may not qualify if:

  • Metabolic abnormalities such as:
  • Lactose intolerant
  • Diabetes Mellitus
  • Hypertension
  • Hypotension
  • Cardiovascular diseases
  • Asthma and other obstructive pulmonary diseases
  • Elevated fasting blood glucose level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maastricht

Maastricht, Limburg, 6229 ER, Netherlands

Location

Related Publications (1)

  • Munsters MJ, Saris WH. Effects of meal frequency on metabolic profiles and substrate partitioning in lean healthy males. PLoS One. 2012;7(6):e38632. doi: 10.1371/journal.pone.0038632. Epub 2012 Jun 13.

    PMID: 22719910DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • WHM Saris, Prof. Dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

June 1, 2010

Last Updated

July 23, 2010

Record last verified: 2010-07

Locations

NL(1)