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: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
19g of lupin crunchy every day for the whole duration of the intervention phase (60 days)
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.
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).
Changes in Local Glucose Uptake into m. soleus
Biopsies were taken from m. soleus
Time frame: Baseline to day 59 of the intervention phase
Changes in Local Glucose Metabolism in m. soleus
Microdialysis was performed in m. soleus
Time frame: Baseline to day 60 of the intervention phase
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
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
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
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
Insulin Sensitivity (changes in the whole body glucose metabolism)
Whole body insulin sensitivity assessed by hyperinsulinemic euglycemic clamp
Time frame: Baseline and day 60 of the intervention phase
Changes in Muscle Volume
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Muscle volume measured by magnetic resonance imaging (MRI)
Time frame: Baseline to day 58 of the intervention phase
Changes in Muscle Function (jump performance)
A jump test was performed
Time frame: Baseline to day 58 of the intervention phase
Changes in Muscle Function (MVC)
Maximal voluntary contractions (MVC) - isometric and isokinetic - were performed
Time frame: Baseline to day 58 of the intervention phase
Compliance
Electronic wearing time devices from Orthotimer were used to assess compliance of the subjects.
Time frame: During 60 days of intervention
Movement
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)