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

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ClinicalTrials.gov Identifier: NCT02698878
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
DLR German Aerospace Center

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).

Condition or disease Intervention/treatment Phase
Local Glucose Uptake Glucose Metabolism Disorders Dietary Supplement: lupin protein Other: Neuromuscular electrical stimulation Device: HEPHAISTOS unloading orthotic device Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Nutrition and Neuromuscular Electrical Stimulation on Local Glucose Uptake Into m. Soleus During 60 Days of Lower Leg Unloading
Study Start Date : April 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Active Comparator: Control Group
Control Group consisting of six healthy male subjects wearing only the HEPHAISTOS ORTHOSIS for lower leg unloading (60 days).
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).
Other Name: HEP

Experimental: 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.
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.
Other Name: NMES

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).
Other Name: HEP




Primary Outcome Measures :
  1. Changes in Local Glucose Uptake into m. soleus [ Time Frame: Baseline to day 59 of the intervention phase ]
    Biopsies were taken from m. soleus

  2. Changes in Local Glucose Metabolism in m. soleus [ Time Frame: Baseline to day 60 of the intervention phase ]
    Microdialysis was performed in m. soleus


Secondary Outcome Measures :
  1. Blood Glucose (changes in the whole body glucose metabolism) [ Time Frame: 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 ]
  2. Blood C-Peptide (changes in the whole body glucose metabolism) [ Time Frame: 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 ]
  3. Blood HbA1c (changes in the whole body glucose metabolism) [ Time Frame: 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 ]
  4. Blood Fructosamine (changes in the whole body glucose metabolism) [ Time Frame: 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 ]
  5. Insulin Sensitivity (changes in the whole body glucose metabolism) [ Time Frame: Baseline and day 60 of the intervention phase ]
    Whole body insulin sensitivity assessed by hyperinsulinemic euglycemic clamp

  6. Changes in Muscle Volume [ Time Frame: Baseline to day 58 of the intervention phase ]
    Muscle volume measured by magnetic resonance imaging (MRI)

  7. Changes in Muscle Function (jump performance) [ Time Frame: Baseline to day 58 of the intervention phase ]
    A jump test was performed

  8. Changes in Muscle Function (MVC) [ Time Frame: Baseline to day 58 of the intervention phase ]
    Maximal voluntary contractions (MVC) - isometric and isokinetic - were performed

  9. Compliance [ Time Frame: During 60 days of intervention ]
    Electronic wearing time devices from Orthotimer were used to assess compliance of the subjects.

  10. Movement [ Time Frame: During 60 days of intervention and during 14 days of the recovery phase (post intervention phase) ]
    Accelerometers were used to assess movement of the subjects.



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698878


Sponsors and Collaborators
DLR German Aerospace Center
Investigators
Study Director: Jörn Rittweger, Prof. Dr. DLR German Aerospace Center
Principal Investigator: Kathrin Schopen, M.Sc. DLR German Aerospace Center
Principal Investigator: Petra Frings-Meuthen, Dr. DLR German Aerospace Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DLR German Aerospace Center
ClinicalTrials.gov Identifier: NCT02698878     History of Changes
Other Study ID Numbers: NHP
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016

Keywords provided by DLR German Aerospace Center:
Lupin Protein
Glucose Metabolism
GLUT4
Muscle Unloading
Neuromuscular Electrical Stimulation

Additional relevant MeSH terms:
Metabolic Diseases
Glucose Metabolism Disorders