Clinical trial NCT02698878: Unloading Induced Effects on Local Glucose Uptake Into m. Soleus
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
Overall status: COMPLETED
Phase: NA
Conditions: Local Glucose Uptake
Glucose Metabolism Disorders
Keywords: Lupin Protein
Glucose Metabolism
GLUT4
Muscle Unloading
Neuromuscular Electrical Stimulation
Lead sponsor: DLR German Aerospace Center
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 13
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Local Glucose Uptake into m. soleus
timeFrame: Baseline to day 59 of the intervention phase
measure: Changes in Local Glucose Metabolism in m. soleus
timeFrame: Baseline to day 60 of the intervention phase
Secondary outcomes:
measure: Blood Glucose (changes in the whole body glucose metabolism)
timeFrame: 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
measure: Blood C-Peptide (changes in the whole body glucose metabolism)
timeFrame: 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
measure: Blood HbA1c (changes in the whole body glucose metabolism)
timeFrame: 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
measure: Blood Fructosamine (changes in the whole body glucose metabolism)
timeFrame: 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
measure: Insulin Sensitivity (changes in the whole body glucose metabolism)
timeFrame: Baseline and day 60 of the intervention phase
measure: Changes in Muscle Volume
timeFrame: Baseline to day 58 of the intervention phase
measure: Changes in Muscle Function (jump performance)
timeFrame: Baseline to day 58 of the intervention phase
measure: Changes in Muscle Function (MVC)
timeFrame: Baseline to day 58 of the intervention phase
measure: Compliance
timeFrame: During 60 days of intervention
measure: Movement
timeFrame: During 60 days of intervention and during 14 days of the recovery phase (post intervention phase)
Other outcomes:
Locations:
Study officials:
affiliation: DLR German Aerospace Center
name: Jörn Rittweger, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: DLR German Aerospace Center
name: Kathrin Schopen, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: DLR German Aerospace Center
name: Petra Frings-Meuthen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.