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临床试验/NCT05470218
NCT05470218进行中(未招募)不适用

Protein, Platelet, and Monocyte

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年7月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
10
试验地点
2
主要终点
p-mTOR in monocytes

研究概览

简要总结

High protein low carbohydrate diets have become popular in recent years to help facilitate weight loss. It is controversial if these diets are associated with an increased risk of cardiovascular disease. Recent work in mice has implicated monocytes/macrophages and mTOR signaling as the culprit cell type driving the increased cardiovascular risk with high protein diets. We aim to build on this preclinical research by evaluating the effects of liquid meals with different protein and leucine (a potent mTOR activator) contents on circulating human monocytes and platelets. Study participants will be given either a low protein liquid meal, a high protein liquid meal, or a low protein liquid meal with additional leucine. Blood will be collected from study participants just just prior to and for several hours after ingestion of the meals. Activation of amino acid-dependent signaling pathways (particularly mTOR) and downstream sequelae will be evaluated in the isolated monocytes and platelets.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • able to drink milk-based liquid mixed meal

排除标准

  • Current Pregnancy
  • Allergies to meal ingredients
  • History of Diabetes
  • History of Heart Disease
  • History of High blood pressure
  • History of Stroke
  • History of Cancer
  • History of Organ transplant
  • Taking Rapamycin/Sirolimus
  • Taking Torisel/Temsirolimus
  • Taking Afinitor/Everolimus
  • Taking any statin medication

研究组 & 干预措施

Standard protein meal

Active Comparator

Participants will receive a standard protein meal, containing about 10% of energy as protein

干预措施: Meal (Other)

High protein meal

Active Comparator

Participants will receive a high protein meal, containing about 50% of energy as protein

干预措施: Meal (Other)

Low protein meal + leucine

Active Comparator

Participants will receive a standard protein meal, containing about 10% of energy as protein to which leucine has been added to match the total leucine content of the high protein meal

干预措施: Meal (Other)

结局指标

主要结局

p-mTOR in monocytes

时间窗: change from before meal at 1 hour and 3 hours, compared to before

次要结局

未报告次要终点

研究者

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

Bettina Mittendorfer

Professor of Medicine

University of Missouri-Columbia

研究点 (2)

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