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临床试验/NCT01473576
NCT01473576已完成不适用

The Impact of Dietary Nitrate Ingestion on Muscle Protein Synthesis in Elderly Type II Diabetics

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2011年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Muscle protein fractional synthetic rate

研究概览

简要总结

A diet rich in leafy green vegetables has been shown to reduce the risk of developing chronic metabolic disease. The health benefits from these particular vegetables may be attributed to their high nitrate content. Recent work suggests that dietary nitrate triggers endogenous nitric oxide release, thereby stimulating vasodilation and improving muscle perfusion in an insulin-independent manner. We hypothesize that in an insulin-resistant state, nitrate co-ingestion will increase muscle perfusion, thereby improving post-prandial delivery of nutrients to skeletal muscle tissue. Specifically, a more efficient delivery of food derived amino acids will stimulate post-prandial muscle protein synthesis and, as such, compensate for a blunted muscle protein synthetic response to food intake in the elderly. This proposal will investigate the efficacy of nitrate co-ingestion as a means to augment muscle protein synthesis in elderly, type 2 diabetes patients and may lead to a novel therapy in the clinical care of type 2 diabetes patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
70 Years 至 85 Years(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Aged between 70-85 years
  • BMI < 30 kg/m2
  • Non insulin-dependent diabetes mellitus type 2 patients (T2DM) ( >1 y since diagnoses)

排除标准

  • Hypertension (according to WHO criteria)[29] and/or cardiovascular disease treated with medication containing nitrates and/or having vasodilatory effects
  • Use of medication, except for oral blood glucose lowering medication
  • Use of insulin
  • All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
  • HbA1c > 10.0% (86 mmol/mol)
  • Donated blood in last 3 months
  • Diagnosed impaired renal or liver function
  • Myocardial infarction within the last 3 years
  • Gastric acid inhibitors
  • Use of anti-coagulants

研究组 & 干预措施

Nitrate

Experimental

Sodium nitrate ingestion prior to ingesting intrinsically labeled protein

干预措施: Nitrate (Dietary Supplement)

结局指标

主要结局

Muscle protein fractional synthetic rate

时间窗: -2, 0, +2, +5 h during the trial

Muscle protein fractional synthetic rate assessed using the muscle biopsy technique.

次要结局

  • Plasma amino acids(every 30 min (from -2 h to + 5 h during the test day))
  • Plasma nitrate(every 30 min (from -2 h to + 5 h during the test day))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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