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
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
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
NCT ID
NCT02698878
First Posted
February 23, 2016
Last Updated
March 7, 2016
Sponsor
DLR German Aerospace Center
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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