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Unloading Induced Effects on Local Glucose Uptake Into m. Soleus (NutriHEP)

Primary Purpose

Local Glucose Uptake, Glucose Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lupin protein
Neuromuscular electrical stimulation
HEPHAISTOS unloading orthotic device
Sponsored by
DLR German Aerospace Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Local Glucose Uptake focused on measuring Lupin Protein, Glucose Metabolism, GLUT4, Muscle Unloading, Neuromuscular Electrical Stimulation

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male volunteers
  • Age: between 20 and 45 years
  • Body mass index (BMI): 20 -26 kg/m2
  • Agreement and signed consent before the study

Exclusion Criteria:

  • Smoker
  • Competitive Athletes
  • Diabetes mellitus
  • Rheumatic disease
  • Muscle or joint disease
  • Bone fractures in the period up to one year before study start
  • Herniated disc
  • Flatfeet (pes planus)
  • Allergy to nuts or legume
  • Vascular diseases
  • Epilepsy
  • Severe hyperlipidemia
  • Anemia (< Hb standard values; standard values healthy men: 13.5 -17.5 g/dl) *
  • Increased thrombosis risk *
  • Kidney disorder: deviations from normal values for creatinine in plasma. (Normal value: Creatinine < 1.20 mg/dl)*
  • Lesions of the cruciate ligaments, or orthopedic surgery in the past 10 years on the side of the Hephaistos orthosis
  • Achilles tendon injury, or rupture in the past 10 years on the side of the orthosis
  • hyper-/hypocalcaemia (abnormal levels of calcium in the blood, normal level: 2.15 - 2.64 mmol/l)
  • Intake of anti-inflammatory drugs during the study
  • Abuse of drugs or alcohol (> than 20-30g alcohol/day)
  • Participation in another clinical study within the last 2 months before the start of this study
  • Increased bleeding tendency (hemophilia, regular use of anticoagulants)
  • History of intolerance to local anesthetics
  • Imprisoned during study
  • Any other condition classed as unsuitable for study participation by the medical executive director
  • prior convictions (objectionable criminal record)

Additional Exclusion Criteria for MRI

  • Metal implants or other osteosynthesis material
  • Pacemaker
  • Claustrophobia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control Group

    Intervention Group

    Arm Description

    Control Group consisting of six healthy male subjects wearing only the HEPHAISTOS ORTHOSIS for lower leg unloading (60 days).

    Intervention group consisting of seven healthy mal subjects, wearing the HEPHAISTOS orthosis for lower leg unloading (60 days), plus receiving lupin protein every day and performing a neuromuscular electrical stimulation training twice a day.

    Outcomes

    Primary Outcome Measures

    Changes in Local Glucose Uptake into m. soleus
    Biopsies were taken from m. soleus
    Changes in Local Glucose Metabolism in m. soleus
    Microdialysis was performed in m. soleus

    Secondary Outcome Measures

    Blood Glucose (changes in the whole body glucose metabolism)
    Blood C-Peptide (changes in the whole body glucose metabolism)
    Blood HbA1c (changes in the whole body glucose metabolism)
    Blood Fructosamine (changes in the whole body glucose metabolism)
    Insulin Sensitivity (changes in the whole body glucose metabolism)
    Whole body insulin sensitivity assessed by hyperinsulinemic euglycemic clamp
    Changes in Muscle Volume
    Muscle volume measured by magnetic resonance imaging (MRI)
    Changes in Muscle Function (jump performance)
    A jump test was performed
    Changes in Muscle Function (MVC)
    Maximal voluntary contractions (MVC) - isometric and isokinetic - were performed
    Compliance
    Electronic wearing time devices from Orthotimer were used to assess compliance of the subjects.
    Movement
    Accelerometers were used to assess movement of the subjects.

    Full Information

    First Posted
    February 23, 2016
    Last Updated
    March 7, 2016
    Sponsor
    DLR German Aerospace Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02698878
    Brief Title
    Unloading Induced Effects on Local Glucose Uptake Into m. Soleus
    Acronym
    NutriHEP
    Official Title
    Effects of Nutrition and Neuromuscular Electrical Stimulation on Local Glucose Uptake Into m. Soleus During 60 Days of Lower Leg Unloading
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    DLR German Aerospace Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The present study aimed to investigate whether a daily intake of lupin protein and a neuromuscular electrical stimulation training twice a day can improve local glucose uptake into m. soleus during a 60 day unloading phase with a special unloading device, the HEPHAISTOS orthosis (HEP).
    Detailed Description
    The 60 day unloading intervention with the HEPHAISTOS unloading device had the following key objectives: primary hypothesis: Assesment and evaluation of insulin sensitivity and local glucose uptake in the unloaded m. soleus and whether it can be improved by dietary supplementation of lupin seeds and neuromuscular electrical stimulation. secondary hypotheses: Assesment and evaluation of unloading-induced reductions in muscle mass and whether they can be mitigated by dietary supplementation of lupin seed and neuromuscular electrical stimulation. Assesment and evaluation of whole-body glycemic effects of the interventions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Local Glucose Uptake, Glucose Metabolism Disorders
    Keywords
    Lupin Protein, Glucose Metabolism, GLUT4, Muscle Unloading, Neuromuscular Electrical Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Control Group consisting of six healthy male subjects wearing only the HEPHAISTOS ORTHOSIS for lower leg unloading (60 days).
    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Intervention group consisting of seven healthy mal subjects, wearing the HEPHAISTOS orthosis for lower leg unloading (60 days), plus receiving lupin protein every day and performing a neuromuscular electrical stimulation training twice a day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    lupin protein
    Intervention Description
    19g of lupin crunchy every day for the whole duration of the intervention phase (60 days)
    Intervention Type
    Other
    Intervention Name(s)
    Neuromuscular electrical stimulation
    Other Intervention Name(s)
    NMES
    Intervention Description
    Individual neuromuscular electrical stimulation training had to be performed twice a day (morning and evening) over the whole duration of the intervention phase (60 days). Subjects were asked to continuously increase the intensity until a maximum intensity of 100mA per training.
    Intervention Type
    Device
    Intervention Name(s)
    HEPHAISTOS unloading orthotic device
    Other Intervention Name(s)
    HEP
    Intervention Description
    Orthotic device which unloads the muscles of the lower leg. Subjects had to wear the device for the whole duration of the intervention phase (60 days).
    Primary Outcome Measure Information:
    Title
    Changes in Local Glucose Uptake into m. soleus
    Description
    Biopsies were taken from m. soleus
    Time Frame
    Baseline to day 59 of the intervention phase
    Title
    Changes in Local Glucose Metabolism in m. soleus
    Description
    Microdialysis was performed in m. soleus
    Time Frame
    Baseline to day 60 of the intervention phase
    Secondary Outcome Measure Information:
    Title
    Blood Glucose (changes in the whole body glucose metabolism)
    Time Frame
    Baseline and day 2 & 1 before the intervention phase, day 4, 14, 28, 42 & 60 of the intervention phase and day 2 & 14 after the intervention phase
    Title
    Blood C-Peptide (changes in the whole body glucose metabolism)
    Time Frame
    Baseline and day 2 & 1 before the intervention phase, day 4, 14, 28, 42 & 60 of the intervention phase and day 2 & 14 after the intervention phase
    Title
    Blood HbA1c (changes in the whole body glucose metabolism)
    Time Frame
    Baseline and day 2 & 1 before the intervention phase, day 4, 14, 28, 42 & 60 of the intervention phase and day 2 & 14 after the intervention phase
    Title
    Blood Fructosamine (changes in the whole body glucose metabolism)
    Time Frame
    Baseline and day 2 & 1 before the intervention phase, day 4, 14, 28, 42 & 60 of the intervention phase and day 2 & 14 after the intervention phase
    Title
    Insulin Sensitivity (changes in the whole body glucose metabolism)
    Description
    Whole body insulin sensitivity assessed by hyperinsulinemic euglycemic clamp
    Time Frame
    Baseline and day 60 of the intervention phase
    Title
    Changes in Muscle Volume
    Description
    Muscle volume measured by magnetic resonance imaging (MRI)
    Time Frame
    Baseline to day 58 of the intervention phase
    Title
    Changes in Muscle Function (jump performance)
    Description
    A jump test was performed
    Time Frame
    Baseline to day 58 of the intervention phase
    Title
    Changes in Muscle Function (MVC)
    Description
    Maximal voluntary contractions (MVC) - isometric and isokinetic - were performed
    Time Frame
    Baseline to day 58 of the intervention phase
    Title
    Compliance
    Description
    Electronic wearing time devices from Orthotimer were used to assess compliance of the subjects.
    Time Frame
    During 60 days of intervention
    Title
    Movement
    Description
    Accelerometers were used to assess movement of the subjects.
    Time Frame
    During 60 days of intervention and during 14 days of the recovery phase (post intervention phase)

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male volunteers Age: between 20 and 45 years Body mass index (BMI): 20 -26 kg/m2 Agreement and signed consent before the study Exclusion Criteria: Smoker Competitive Athletes Diabetes mellitus Rheumatic disease Muscle or joint disease Bone fractures in the period up to one year before study start Herniated disc Flatfeet (pes planus) Allergy to nuts or legume Vascular diseases Epilepsy Severe hyperlipidemia Anemia (< Hb standard values; standard values healthy men: 13.5 -17.5 g/dl) * Increased thrombosis risk * Kidney disorder: deviations from normal values for creatinine in plasma. (Normal value: Creatinine < 1.20 mg/dl)* Lesions of the cruciate ligaments, or orthopedic surgery in the past 10 years on the side of the Hephaistos orthosis Achilles tendon injury, or rupture in the past 10 years on the side of the orthosis hyper-/hypocalcaemia (abnormal levels of calcium in the blood, normal level: 2.15 - 2.64 mmol/l) Intake of anti-inflammatory drugs during the study Abuse of drugs or alcohol (> than 20-30g alcohol/day) Participation in another clinical study within the last 2 months before the start of this study Increased bleeding tendency (hemophilia, regular use of anticoagulants) History of intolerance to local anesthetics Imprisoned during study Any other condition classed as unsuitable for study participation by the medical executive director prior convictions (objectionable criminal record) Additional Exclusion Criteria for MRI Metal implants or other osteosynthesis material Pacemaker Claustrophobia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jörn Rittweger, Prof. Dr.
    Organizational Affiliation
    DLR German Aerospace Center
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Kathrin Schopen, M.Sc.
    Organizational Affiliation
    DLR German Aerospace Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Petra Frings-Meuthen, Dr.
    Organizational Affiliation
    DLR German Aerospace Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28207840
    Citation
    Zange J, Schopen K, Albracht K, Gerlach DA, Frings-Meuthen P, Maffiuletti NA, Bloch W, Rittweger J. Using the Hephaistos orthotic device to study countermeasure effectiveness of neuromuscular electrical stimulation and dietary lupin protein supplementation, a randomised controlled trial. PLoS One. 2017 Feb 16;12(2):e0171562. doi: 10.1371/journal.pone.0171562. eCollection 2017.
    Results Reference
    derived

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    Unloading Induced Effects on Local Glucose Uptake Into m. Soleus

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