Effects of Nutrition and Neuromuscular Electrical Stimulation on Local Glucose Uptake Into m. Soleus During 60 Days of Lower Leg Unloading
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Changes in Local Glucose Uptake into m. soleus
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers
- •Age: between 20 and 45 years
- •Body mass index (BMI): 20 -26 kg/m2
- •Agreement and signed consent before the study
排除标准
- •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
- •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
研究组 & 干预措施
Control Group
Control Group consisting of six healthy male subjects wearing only the HEPHAISTOS ORTHOSIS for lower leg unloading (60 days).
干预措施: HEPHAISTOS unloading orthotic device (Device)
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.
干预措施: lupin protein (Dietary Supplement)
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.
干预措施: Neuromuscular electrical stimulation (Other)
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.
干预措施: HEPHAISTOS unloading orthotic device (Device)
结局指标
主要结局
Changes in Local Glucose Uptake into m. soleus
时间窗: Baseline to day 59 of the intervention phase
Biopsies were taken from m. soleus
Changes in Local Glucose Metabolism in m. soleus
时间窗: Baseline to day 60 of the intervention phase
Microdialysis was performed in m. soleus
次要结局
- Movement(During 60 days of intervention and during 14 days of the recovery phase (post intervention phase))
- Changes in Muscle Function (jump performance)(Baseline to day 58 of the intervention phase)
- Blood Glucose (changes in the whole body glucose metabolism)(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)
- Changes in Muscle Function (MVC)(Baseline to day 58 of the intervention phase)
- Compliance(During 60 days of intervention)
- Blood C-Peptide (changes in the whole body glucose metabolism)(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)(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)(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)
- Changes in Muscle Volume(Baseline to day 58 of the intervention phase)
- Insulin Sensitivity (changes in the whole body glucose metabolism)(Baseline and day 60 of the intervention phase)