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

March 7, 2016 updated by: DLR German Aerospace Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

13

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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.
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 Names:
  • HEP
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 Names:
  • NMES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Local Glucose Uptake into m. soleus
Time Frame: Baseline to day 59 of the intervention phase
Biopsies were taken from m. soleus
Baseline to day 59 of the intervention phase
Changes in Local Glucose Metabolism in m. soleus
Time Frame: Baseline to day 60 of the intervention phase
Microdialysis was performed in m. soleus
Baseline to day 60 of the intervention phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
Baseline and day 60 of the intervention phase
Changes in Muscle Volume
Time Frame: Baseline to day 58 of the intervention phase
Muscle volume measured by magnetic resonance imaging (MRI)
Baseline to day 58 of the intervention phase
Changes in Muscle Function (jump performance)
Time Frame: Baseline to day 58 of the intervention phase
A jump test was performed
Baseline to day 58 of the intervention phase
Changes in Muscle Function (MVC)
Time Frame: Baseline to day 58 of the intervention phase
Maximal voluntary contractions (MVC) - isometric and isokinetic - were performed
Baseline to day 58 of the intervention phase
Compliance
Time Frame: During 60 days of intervention
Electronic wearing time devices from Orthotimer were used to assess compliance of the subjects.
During 60 days of intervention
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.
During 60 days of intervention and during 14 days of the recovery phase (post intervention phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DLR German Aerospace Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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