Bedrest, Feeding Pattern, and Insulin Sensitivity

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521025
• Other study ID #: MEC 15-3-035
• Status: Completed
• Phase: N/A
• First received: August 3, 2015
• Last updated: July 26, 2016
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrophy
• Atrophy, Disuse
• Insulin Resistance
• Muscular Disorders, Atrophic

Intervention

Other:
• Intermittent feeding pattern
Intermittent feeding
• Continuous feeding pattern
Continuous feeding

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity (measured as glucose infusion rate during hyperinsulinaemic-euglycaemic clamp)		7 days bedrest	No
Secondary	Change in muscle mass (measured as upper leg muscle cross-sectional area with CT scan)	Via single-slice CT scan	7 days bedrest	No
Secondary	Change in lean tissue (measured via DEXA scan)	Via DEXA	7 days bedrest	No