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Completed

NCT Number: NCT02698878

Unloading Induced Effects on Local Glucose Uptake Into m. Soleus

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).

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Key information

Conditions

Local Glucose Uptake Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lupin protein

Dietary Supplement

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

Neuromuscular electrical stimulation

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.

Other names: NMES

HEPHAISTOS unloading orthotic device

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 names: HEP

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

DLR German Aerospace Center

Other

Registry information

Official study title

Effects of Nutrition and Neuromuscular Electrical Stimulation on Local Glucose Uptake Into m. Soleus During 60 Days of Lower Leg Unloading

Acronym: NutriHEP

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 4, 2016
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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