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临床试验/NCT05624333
NCT05624333已完成不适用

Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.

Wageningen University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年1月9日最近更新:
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
38
试验地点
1
主要终点
Muscle Protein Synthesis (MPS)

研究概览

简要总结

Consumers are increasingly encouraged to consume more plant-based foods and lower their consumption of foods from animal origin. However, the consequences of such a transition on muscle mass still remains to be explored. This is of particular importance in the older population, where sarcopenia is highly prevalent. The aim of this randomized controlled cross-over study is to investigate the short-term effect of a 10-day controlled vegan diet on daily muscle fractional synthesis rates in comparison to a 10-day controlled omnivorous diet in 35 community-dwelling older adults.

Participants will follow a fully controlled vegan diet, directly followed by a fully controlled omnivorous diet for 10 days, or vice versa. Researchers will compare the effect of the vegan diet to the effect of the omnivorous diet.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 79 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Aged 65-79 years old;
  • •Community-dwelling;
  • •BMI 20-35 kg/m^2.

排除标准

  • •Following a vegetarian or vegan diet during the six months prior to the study;
  • •Following a diet that affects protein intake during the six months prior to the study;
  • •Participating in a structured exercise training program in the past three months;
  • •5% or more body weight loss during three months before the start of the study;
  • •Being diagnosed with one of the following: diabetes; renal disease; neurological or neuromuscular disorders; serious cardiovascular diseases; cancer; chronic obstructive lung disease (COPD);
  • •Chronic use of medication that affects muscle function, e.g. corticosteroids, metformin, insulin;
  • •The use of the following medicines: acenocoumarol (sintrom); phenprocoumon (marcoumar); dabigatran (pradaxa); apixaban (eliquis); rivaroxaban (xarelto); clopidogrel (plavix); combination of acetylsalicylic acid or carbasalate calcium (ascal) with dipyridamole.
  • •Allergic or intolerant to any product included in the diets;
  • •Not willing to stop nutritional supplements, with the exception of supplements on medical advice, and vitamin D;
  • •Not willing or afraid to give blood or undergo a muscle biopsy during the study;
  • •Unwilling to eat a vegan and an omnivorous diet for ten days each;
  • •Currently a research participant in another trial or participated in a clinical trial during three months before the start of the measurement period;
  • •Not being able to understand Dutch;
  • •Not having a general physician.

研究组 & 干预措施

VO group

Other

Vegan diet followed by Omnivorous diet

干预措施: Vegan diet (intervention) (Other)

VO group

Other

Vegan diet followed by Omnivorous diet

干预措施: Omnivorous diet (control) (Other)

OV group

Other

Omnivorous diet followed by Vegan diet

干预措施: Vegan diet (intervention) (Other)

OV group

Other

Omnivorous diet followed by Vegan diet

干预措施: Omnivorous diet (control) (Other)

结局指标

主要结局

Muscle Protein Synthesis (MPS)

时间窗: 10 days

MPS, expressed as daily fractional synthesis rates (FSR, %/day), will be assessed using a deuterium oxide protocol. Daily FSR will be calculated using the 2\^H-alanine enrichment in plasma and the mixed muscle-bound 2\^H-alanine enrichment.

次要结局

  • Change in fasting plasma glucose(Change after 10 days of following each diet)
  • Change in fasting plasma insulin(Change after 10 days of following each diet)
  • Change in blood pressure(Change after 10 days of following each diet)
  • Appetite(Measured daily for 10 days during each diet)
  • Change in fasting plasma lipid profile(Change after 10 days of following each diet)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisette de Groot

Prof. Dr. Ir. L.C.P.G.M. (Lisette) de Groot

Wageningen University

研究点 (1)

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