Unloading Induced Effects on Local Glucose Uptake Into m. Soleus (NutriHEP)

German Aerospace Center (DLR)

Status: Completed

Conditions: Glucose Metabolism Disorders; Local Glucose Uptake

Treatments: Other: Neuromuscular electrical stimulation; Device: HEPHAISTOS unloading orthotic device; Dietary Supplement: lupin protein

Study type: Interventional

Funder types: Other

Identifiers

NCT02698878

NHP

Details and patient eligibility

About

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).

Full 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.

Enrollment: 13 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Control Group consisting of six healthy male subjects wearing only the HEPHAISTOS ORTHOSIS for lower leg unloading (60 days).

Treatment:

Device: HEPHAISTOS unloading orthotic device

Intervention Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: lupin protein

Device: HEPHAISTOS unloading orthotic device

Other: Neuromuscular electrical stimulation