Back to resultsBedrest, Feeding Pattern, and Insulin Sensitivity
Primary Purpose
Atrophy, Disuse, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intermittent feeding pattern
Continuous feeding pattern
Sponsored by
About this trial
This is an interventional prevention trial for Atrophy, Disuse
Eligibility Criteria
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
Sites / Locations
- Maastricht University Medical Center+
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intermittent feeding
Continuous feeding
Arm Description
Intermittent feeding pattern throughout the bedrest period, with 4 boluses per day
Continuous feeding pattern throughout the bedrest period, with 4 boluses per day, without breaks in food supply.
Outcomes
Primary Outcome Measures
Change in insulin sensitivity (measured as glucose infusion rate during hyperinsulinaemic-euglycaemic clamp)
Secondary Outcome Measures
Change in muscle mass (measured as upper leg muscle cross-sectional area with CT scan)
Via single-slice CT scan
Change in lean tissue (measured via DEXA scan)
Via DEXA
Full Information
NCT ID
NCT02521025
First Posted
August 3, 2015
Last Updated
July 26, 2016
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02521025
Brief Title
Bedrest, Feeding Pattern, and Insulin Sensitivity
Official Title
The Impact of Continuous Versus Intermittent Feeding on Changes in Insulin Sensitivity During Bed-rest
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy, Disuse, Insulin Resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intermittent feeding
Arm Type
Experimental
Arm Description
Intermittent feeding pattern throughout the bedrest period, with 4 boluses per day
Arm Title
Continuous feeding
Arm Type
Experimental
Arm Description
Continuous feeding pattern throughout the bedrest period, with 4 boluses per day, without breaks in food supply.
Intervention Type
Other
Intervention Name(s)
Intermittent feeding pattern
Intervention Description
Intermittent feeding
Intervention Type
Other
Intervention Name(s)
Continuous feeding pattern
Intervention Description
Continuous feeding
Primary Outcome Measure Information:
Title
Change in insulin sensitivity (measured as glucose infusion rate during hyperinsulinaemic-euglycaemic clamp)
Time Frame
7 days bedrest
Secondary Outcome Measure Information:
Title
Change in muscle mass (measured as upper leg muscle cross-sectional area with CT scan)
Description
Via single-slice CT scan
Time Frame
7 days bedrest
Title
Change in lean tissue (measured via DEXA scan)
Description
Via DEXA
Time Frame
7 days bedrest
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc van Loon
Organizational Affiliation
Maastricht University Medical Centre+
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229ER
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
32651634
Citation
Gonzalez JT, Dirks ML, Holwerda AM, Kouw IWK, van Loon LJC. Intermittent versus continuous enteral nutrition attenuates increases in insulin and leptin during short-term bed rest. Eur J Appl Physiol. 2020 Sep;120(9):2083-2094. doi: 10.1007/s00421-020-04431-4. Epub 2020 Jul 10.
Results Reference
derived
PubMed Identifier
31721213
Citation
Dirks ML, Miotto PM, Goossens GH, Senden JM, Petrick HL, van Kranenburg J, van Loon LJC, Holloway GP. Short-term bed rest-induced insulin resistance cannot be explained by increased mitochondrial H2 O2 emission. J Physiol. 2020 Jan;598(1):123-137. doi: 10.1113/JP278920. Epub 2019 Dec 26.
Results Reference
derived
PubMed Identifier
30645176
Citation
Dirks ML, Smeets JSJ, Holwerda AM, Kouw IWK, Marzuca-Nassr GN, Gijsen AP, Holloway GP, Verdijk LB, van Loon LJC. Dietary feeding pattern does not modulate the loss of muscle mass or the decline in metabolic health during short-term bed rest. Am J Physiol Endocrinol Metab. 2019 Mar 1;316(3):E536-E545. doi: 10.1152/ajpendo.00378.2018. Epub 2019 Jan 15.
Results Reference
derived
Learn more about this trial
Bedrest, Feeding Pattern, and Insulin Sensitivity
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