NCT02521025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

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

First Submitted

Initial submission to the registry

August 3, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

August 3, 2015

Last Update Submit

July 26, 2016

Conditions

Atrophy, DisuseInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Change in insulin sensitivity (measured as glucose infusion rate during hyperinsulinaemic-euglycaemic clamp)

    7 days bedrest

Secondary Outcomes (2)

  • Change in muscle mass (measured as upper leg muscle cross-sectional area with CT scan)

    7 days bedrest

  • Change in lean tissue (measured via DEXA scan)

    7 days bedrest

Study Arms (2)

Intermittent feeding

EXPERIMENTAL

Intermittent feeding pattern throughout the bedrest period, with 4 boluses per day

Other: Intermittent feeding pattern

Continuous feeding

EXPERIMENTAL

Continuous feeding pattern throughout the bedrest period, with 4 boluses per day, without breaks in food supply.

Other: Continuous feeding pattern

Interventions

Intermittent feeding patternOTHER

Intermittent feeding

Intermittent feeding
Continuous feeding patternOTHER

Continuous feeding

Continuous feeding

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18.5 and 35
  • Recreationally active

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 32651634DERIVED

  • 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.

    PMID: 31721213DERIVED

  • 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.

    PMID: 30645176DERIVED

MeSH Terms

Conditions

Muscular Disorders, AtrophicInsulin Resistance

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Luc van Loon

    Maastricht University Medical Centre+

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 13, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

NL(1)