Unloading Induced Effects on Local Glucose Uptake Into m. Soleus

NCT ID: NCT02698878

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-08-31

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.

Conditions

Local Glucose Uptake; Glucose Metabolism Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

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

Group Type: ACTIVE_COMPARATOR

HEPHAISTOS unloading orthotic device

Intervention Type: 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).

Intervention Group

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.

Group Type: EXPERIMENTAL

lupin protein

Intervention Type: DIETARY_SUPPLEMENT

19g of lupin crunchy every day for the whole duration of the intervention phase (60 days)

Neuromuscular electrical stimulation

Intervention Type: OTHER

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.

HEPHAISTOS unloading orthotic device

Intervention Type: 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).

Interventions

lupin protein

19g of lupin crunchy every day for the whole duration of the intervention phase (60 days)

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

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).

Intervention Type: DEVICE

Other Intervention Names

NMES; HEP

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)

• Metal implants or other osteosynthesis material
• Pacemaker
• Claustrophobia

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

DLR German Aerospace Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jörn Rittweger, Prof. Dr.

Role: STUDY_DIRECTOR

DLR German Aerospace Center

Kathrin Schopen, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

DLR German Aerospace Center

Petra Frings-Meuthen, Dr.

Role: PRINCIPAL_INVESTIGATOR

DLR German Aerospace Center

References

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.

Reference Type: DERIVED

PMID: 28207840 (View on PubMed)

Other Identifiers

NHP

Identifier Type: -

Identifier Source: org_study_id