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临床试验/NCT04677920
NCT04677920进行中(未招募)不适用

THE HEALTHY COOKIE ENERGY STUDY: Understanding How Healthy Cookies Affect Mitochondrial Biology

Ohio State University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年9月7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
24
试验地点
1
主要终点
Changes in cardiolipin species

研究概览

简要总结

The proposed research is an intervention and feasibility pilot trial designed to determine if short-term consumption of healthy cookies made with an oil rich in linoleic acid can influence mitochondria biology in white blood cells and muscle. The hypothesis of the study is that consuming 1 healthy cookie rich in linoleic acid each day for two weeks will improve mitochondrial biology in white blood cells and muscle.

详细描述

Linoleic acid has many health benefits including altering body composition and energy metabolism, possibly through its impact on cardiolipin and mitochondria.

The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following four specific aims

Aim 1) To assess muscle biopsy yield with a micro biopsy needle

Aim 2) To determine the amount of peripheral blood mononuclear cells (PBMC) and muscle needed to measure mitochondria function

Aim 3) To assess the feasibility of measuring mitochondria function on fresh PBMC and muscle samples

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Nonsmoker

排除标准

  • •Allergy/intolerance to lidocaine
  • •Gastrointestinal diseases or disorders (including pancreatic) or gastric bypass surgery
  • •Food Allergy or Intolerance
  • •Any dietary restriction where consumption of these healthy cookies or any ingredient would be contraindicated
  • •Use of medications where consuming the healthy cookies would be contraindicated
  • •Pregnancy
  • •Use of anticoagulant, antiplatelet, or other blood thinner medications

研究组 & 干预措施

Healthy Cookie Group

Experimental

All participants in the study

干预措施: High Linoleic Acid Healthy Cookies (Other)

结局指标

主要结局

Changes in cardiolipin species

时间窗: Week 0 to week 2

Cardiolipin species in peripheral blood mononuclear cells and skeletal muscle

Changes in mitochondria function

时间窗: Week 0 to Week 2

Mitochondria function measured in peripheral blood mononuclear cells and skeletal muscle

Correlation of mitochondrial biology in blood and skeletal muscle

时间窗: Week 0 and week 2

Correlation of mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle

次要结局

  • Changes in fasting fatty acid levels(Week 0 to week 2)
  • Correlation of fatty acids with mitochondrial function and cardiolipin species(Week 0 and week 2)
  • Correlation of cardiolipin with global sleep quality score, Cambridge physical activity index and dietary intake of omega-3 fats(Week 0 and week 2)
  • Correlation of cardiolipin with body mass index, sagittal diameter (abdominal thickness), walking speed and grip strength(Week 0 and week 2)

研究者

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

Martha Belury

Associate Professor

Ohio State University

研究点 (1)

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