Trials / Completed
CompletedNCT02698878
Unloading Induced Effects on Local Glucose Uptake Into m. Soleus
Effects of Nutrition and Neuromuscular Electrical Stimulation on Local Glucose Uptake Into m. Soleus During 60 Days of Lower Leg Unloading
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- DLR German Aerospace Center · Academic / Other
- Sex
- Male
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | lupin protein | 19g of lupin crunchy every day for the whole duration of the intervention phase (60 days) |
| OTHER | Neuromuscular electrical stimulation | 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. |
| DEVICE | HEPHAISTOS unloading orthotic 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). |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2014-08-01
- Completion
- 2014-08-01
- First posted
- 2016-03-04
- Last updated
- 2016-03-08
Source: ClinicalTrials.gov record NCT02698878. Inclusion in this directory is not an endorsement.