Bedrest, Feeding Pattern, and Insulin Sensitivity

July 26, 2016 updated by: Maastricht University Medical Center

The Impact of Continuous Versus Intermittent Feeding on Changes in Insulin Sensitivity During Bed-rest

In the present study, the investigators will assess the impact of two different feeding patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following bedrest.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the present study, the investigators will assess the impact of two different feeding patterns on insulin sensitivity and muscle mass following bedrest. Healthy, young males will be fed in a continuous (no breaks in food supply) or intermittent (in boluses throughout the day) manner.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ER
        • Maastricht University Medical Center+

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI between 18.5 and 35
  • Recreationally active

Exclusion Criteria:

  • Type 2 diabetes
  • Performing progressive resistance training in 6 months prior to study
  • Back/knee/leg problems
  • Hypertension
  • Use of certain anticoagulants
  • All co morbidities interacting with mobility and muscle metabolism of the lower limbs
  • Blood donation in past 3 months

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent feeding
Intermittent feeding pattern throughout the bedrest period, with 4 boluses per day
Other: Intermittent feeding pattern
Intermittent feeding
Experimental: Continuous feeding
Continuous feeding pattern throughout the bedrest period, with 4 boluses per day, without breaks in food supply.
Other: Continuous feeding pattern
Continuous feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in insulin sensitivity (measured as glucose infusion rate during hyperinsulinaemic-euglycaemic clamp)
Time Frame: 7 days bedrest
7 days bedrest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle mass (measured as upper leg muscle cross-sectional area with CT scan)
Time Frame: 7 days bedrest
Via single-slice CT scan
7 days bedrest
Change in lean tissue (measured via DEXA scan)
Time Frame: 7 days bedrest
Via DEXA
7 days bedrest

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Luc van Loon, Maastricht University Medical Centre+

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

October 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 15-3-035

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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