Local Glucose UptakeNutriHEPNCT02698878
Unloading Induced Effects on Local Glucose Uptake Into m. Soleus
A study testing lupin protein, Neuromuscular electrical stimulation and HEPHAISTOS unloading orthotic device in people with Local Glucose Uptake and Glucose Metabolism Disorders, run by DLR German Aerospace Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Local Glucose Uptake, Glucose Metabolism Disorders
- What is being tested?
- lupin protein, Neuromuscular electrical stimulation and HEPHAISTOS unloading orthotic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers
- Age: between 20 and 45 years
- Body mass index (BMI): 20 -26 kg/m2
- Agreement and signed consent before the study
Who cannot join
- Smoker
- Competitive Athletes
- Diabetes mellitus
- Rheumatic disease
- Muscle or joint disease
- Bone fractures in the period up to one year before study start
Show all 30Show fewer
- 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
About this study
Official title: 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).
Read the 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
- Being tested
- lupin protein, Neuromuscular electrical stimulation, HEPHAISTOS unloading orthotic device
- Keywords
- Lupin Protein, Glucose Metabolism, GLUT4, Muscle Unloading, Neuromuscular Electrical Stimulation
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lupin proteinDietary supplement
19g of lupin crunchy every day for the whole duration of the intervention phase (60 days)
Neuromuscular electrical stimulationOther
Also called NMES
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 deviceDevice
Also called HEP
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Control Group consisting of six healthy male subjects wearing only the HEPHAISTOS ORTHOSIS for lower leg unloading (60 days). Receives: Device: HEPHAISTOS unloading orthotic device |
| Intervention Group | Experimental | 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. Receives: Dietary Supplement: lupin protein; Other: Neuromuscular electrical stimulation; Device: HEPHAISTOS unloading orthotic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Local Glucose Uptake into m. soleus
Biopsies were taken from m. soleus
Measured: Baseline to day 59 of the intervention phase
Changes in Local Glucose Metabolism in m. soleus
Microdialysis was performed in m. soleus
Measured: Baseline to day 60 of the intervention phase
Secondary outcomes (10)
Blood Glucose (changes in the whole body glucose metabolism)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Whole body insulin sensitivity assessed by hyperinsulinemic euglycemic clamp
Measured: Baseline and day 60 of the intervention phase
Changes in Muscle Volume
Muscle volume measured by magnetic resonance imaging (MRI)
Measured: Baseline to day 58 of the intervention phase
Changes in Muscle Function (jump performance)
A jump test was performed
Measured: Baseline to day 58 of the intervention phase
Changes in Muscle Function (MVC)
Maximal voluntary contractions (MVC) - isometric and isokinetic - were performed
Measured: Baseline to day 58 of the intervention phase
Compliance
Electronic wearing time devices from Orthotimer were used to assess compliance of the subjects.
Measured: During 60 days of intervention
Movement
Accelerometers were used to assess movement of the subjects.
Measured: During 60 days of intervention and during 14 days of the recovery phase (post intervention phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Local Glucose UptakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- DLR German Aerospace Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörn Rittweger, Prof. Dr., Study director, DLR German Aerospace CenterKathrin Schopen, M.Sc., Principal investigator, DLR German Aerospace CenterPetra Frings-Meuthen, Dr., Principal investigator, DLR German Aerospace Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698878
- Sponsor's protocol ID
- NHP
- Acronym
- NutriHEP
- Status last verified
- Mar 2016
- First submitted
- 23 Feb 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28207840
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutrition and Neuromuscular Electrical Stimulation on Local Glucose Uptake Into m. Soleus During 60 Days of Lower Leg Unloading
- ClinicalTrials.gov ID
- NCT02698878
- Acronym / sponsor ID
- NutriHEP / NHP
- Conditions
- Local Glucose Uptake, Glucose Metabolism Disorders
- Keywords
- Lupin Protein, Glucose Metabolism, GLUT4, Muscle Unloading, Neuromuscular Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- DLR German Aerospace CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: HEPHAISTOS unloading orthotic deviceControl Group consisting of six healthy male subjects wearing only the HEPHAISTOS ORTHOSIS for lower leg unloading (60 days). |
| Intervention Group | Experimental | Dietary Supplement: lupin protein, Other: Neuromuscular electrical stimulation, Device: HEPHAISTOS unloading orthotic deviceIntervention 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male volunteers
- Age: between 20 and 45 years
- Body mass index (BMI): 20 -26 kg/m2
- Agreement and signed consent before the study
Key exclusion criteria (30 listed)
- Smoker
- Competitive Athletes
- Diabetes mellitus
- Rheumatic disease
- Muscle or joint disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lupin protein19g of lupin crunchy every day for the whole duration of the intervention phase (60 days) | Dietary supplement | Intervention Group |
| Neuromuscular electrical stimulationAlso: NMESIndividual 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 | Intervention Group |
| HEPHAISTOS unloading orthotic deviceAlso: HEPOrthotic 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). | Device | Control Group, Intervention Group |
Primary outcome
Changes in Local Glucose Uptake into m. soleus
Time frame: Baseline to day 59 of the intervention phase
Biopsies were taken from m. soleus
Changes in Local Glucose Metabolism in m. soleus
Time frame: Baseline to day 60 of the intervention phase
Microdialysis was performed in m. soleus
10 secondary outcomes
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
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
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
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
Insulin Sensitivity (changes in the whole body glucose metabolism)
Time frame: Baseline and day 60 of the intervention phase
Changes in Muscle Volume
Time frame: Baseline to day 58 of the intervention phase
Changes in Muscle Function (jump performance)
Time frame: Baseline to day 58 of the intervention phase
Changes in Muscle Function (MVC)
Time frame: Baseline to day 58 of the intervention phase
Compliance
Time frame: During 60 days of intervention
Movement
Time frame: During 60 days of intervention and during 14 days of the recovery phase (post intervention phase)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Derived from this study: PubMed 28207840Zange 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörn Rittweger, Prof. Dr. study director
DLR German Aerospace Center
Kathrin Schopen, M.Sc. principal investigator
DLR German Aerospace Center
Petra Frings-Meuthen, Dr. principal investigator
DLR German Aerospace Center
Questions about this trial
What is this clinical trial studying?
A study testing lupin protein, Neuromuscular electrical stimulation and HEPHAISTOS unloading orthotic device in people with Local Glucose Uptake and Glucose Metabolism Disorders, run by DLR German Aerospace Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Local Glucose Uptake into m. soleus (time frame: Baseline to day 59 of the intervention phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02698878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016; AzTrials last refreshed its copy on 1 Nov 2026.