Clinical Trials Directory

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

TypeNameDescription
DIETARY_SUPPLEMENTlupin protein19g of lupin crunchy every day for the whole duration of the intervention phase (60 days)
OTHERNeuromuscular electrical stimulationIndividual 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.
DEVICEHEPHAISTOS unloading orthotic deviceOrthotic 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.