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Bedrest, Feeding Pattern, and Insulin Sensitivity

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02521025
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
6
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intermittent feeding pattern
  • Other: Continuous feeding pattern
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Impact of Continuous Versus Intermittent Feeding on Changes in Insulin Sensitivity During Bed-rest
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in insulin sensitivity (measured as glucose infusion rate during hyperinsulinaemic-euglycaemic clamp) [7 days bedrest]

Secondary Outcome Measures

  1. Change in muscle mass (measured as upper leg muscle cross-sectional area with CT scan) [7 days bedrest]

    Via single-slice CT scan

  2. Change in lean tissue (measured via DEXA scan) [7 days bedrest]

    Via DEXA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maastricht University Medical Center+ Maastricht Limburg Netherlands 6229ER

Sponsors and Collaborators

  • Maastricht University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT02521025
Other Study ID Numbers:
  • MEC 15-3-035
First Posted:
Aug 13, 2015
Last Update Posted:
Jul 27, 2016
Last Verified:
Jul 1, 2016
Additional relevant MeSH terms:
Muscular Disorders, Atrophic
Insulin Resistance

Study Results

No Results Posted as of Jul 27, 2016