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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).
The 60 day unloading intervention with the HEPHAISTOS unloading device had the following key objectives:
primary hypothesis:
secondary hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Control Group consisting of six healthy male subjects wearing only the HEPHAISTOS ORTHOSIS for lower leg unloading (60 days). |
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| Intervention Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lupin protein | Dietary Supplement | 19g of lupin crunchy every day for the whole duration of the intervention phase (60 days) |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Local Glucose Uptake into m. soleus | Biopsies were taken from m. soleus | Baseline to day 59 of the intervention phase |
| Changes in Local Glucose Metabolism in m. soleus | Microdialysis was performed in m. soleus | Baseline to day 60 of the intervention phase |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose (changes in the whole body glucose metabolism) | 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 | |
| Blood C-Peptide (changes in the whole body glucose metabolism) |
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Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria for MRI
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| Name | Affiliation | Role |
|---|---|---|
| Jörn Rittweger, Prof. Dr. | DLR German Aerospace Center | Study Director |
| Kathrin Schopen, M.Sc. | DLR German Aerospace Center | Principal Investigator |
| Petra Frings-Meuthen, Dr. | DLR German Aerospace Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28207840 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 13, 2018 | |
| Reset | Oct 1, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 13, 2018 | Oct 1, 2018 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Neuromuscular electrical stimulation | Other | 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. |
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| HEPHAISTOS unloading orthotic device | Device | 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). |
|
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| 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 |
| Blood HbA1c (changes in the whole body glucose metabolism) | 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 |
| Blood Fructosamine (changes in the whole body glucose metabolism) | 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 |
| Insulin Sensitivity (changes in the whole body glucose metabolism) | Whole body insulin sensitivity assessed by hyperinsulinemic euglycemic clamp | Baseline and day 60 of the intervention phase |
| Changes in Muscle Volume | Muscle volume measured by magnetic resonance imaging (MRI) | Baseline to day 58 of the intervention phase |
| Changes in Muscle Function (jump performance) | A jump test was performed | Baseline to day 58 of the intervention phase |
| Changes in Muscle Function (MVC) | Maximal voluntary contractions (MVC) - isometric and isokinetic - were performed | Baseline to day 58 of the intervention phase |
| Compliance | Electronic wearing time devices from Orthotimer were used to assess compliance of the subjects. | During 60 days of intervention |
| Movement | Accelerometers were used to assess movement of the subjects. | During 60 days of intervention and during 14 days of the recovery phase (post intervention phase) |