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临床试验/NCT03877276
NCT03877276进行中(未招募)不适用

Dietary Oxalate and Immune Cell Function

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2016年7月21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
82
试验地点
2
主要终点
Change in monocyte cellular energetics after 5 hours

研究概览

简要总结

The purpose of this study is to evaluate mitochondrial function in white blood cells and platelets from healthy individuals following dietary oxalate intake.

详细描述

Inflammation and dietary oxalate have been shown to play an important role in the development of kidney stones. Oxalate is a small molecule found in plants and plant-derived food. Individuals that have high oxalate intake have an increased risk of developing kidney stones. The co-investigators have previously shown that healthy subjects that consume dietary oxalate have increased plasma and urine oxalate.

White blood cells are essential for the immune response and rely on the mitochondria to carry out important cell functions. The Principal Investigator's current research shows that patients with calcium oxalate kidney stones have decreased mitochondrial function in their immune cells. Using the expertise of the investigators, this study will test whether oxalate has a direct effect on mitochondrial function in immune cells from healthy subjects. This information could help us understand the role of oxalate on the immune system during kidney stone pathogenesis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mentally competent adults who are able to read and comprehend the consent form, written in English
  • Male or Female
  • Age 18 to 70 years
  • Non-tobacco users
  • BMI between 19 and 27
  • Willingness to abstain from vigorous exercise during study period
  • Normal blood comprehensive metabolic panel

排除标准

  • Mentally incompetent adults who are unable to read or comprehend the consent form, written in English
  • Pregnant females
  • Active medical problems
  • History of kidney stones
  • Any medical disorder that could influence absorption or excretion of oxalate
  • BMI less than 19 or greater than 27
  • Tobacco users
  • Current use of medications or dietary supplements

研究组 & 干预措施

3d Diet+Kale Smoothie+Breakfast

Experimental

3 days of prepared meals with fasting on the final day. On the final day, participants will return to the study site and drink a prepared kale smoothie and be provided a breakfast meal.

干预措施: Kale smoothie (Dietary Supplement)

3d Diet+Blended Smoothie+Breakfast

Experimental

3 days of prepared meals with fasting on the final day. On final day, participants will return to the study site and drink a prepared blended smoothie and be provided a breakfast meal.

干预措施: Breakfast (Dietary Supplement)

3d Diet+V Spinach Smoothie+Breakfast

Experimental

3 days of prepared meals with fasting on the final day. On final day, participants will return to the study site and drink a prepared blended spinach smoothie with varying amounts of spinach and be provided a breakfast meal.

干预措施: Breakfast (Dietary Supplement)

3d Diet+Blended Smoothie+Breakfast

Experimental

3 days of prepared meals with fasting on the final day. On final day, participants will return to the study site and drink a prepared blended smoothie and be provided a breakfast meal.

干预措施: Blended smoothie (Dietary Supplement)

3d Diet+V Spinach Smoothie+Breakfast

Experimental

3 days of prepared meals with fasting on the final day. On final day, participants will return to the study site and drink a prepared blended spinach smoothie with varying amounts of spinach and be provided a breakfast meal.

干预措施: V spinach smoothie (Dietary Supplement)

3d Diet+Spinach Smoothie+Breakfast

Experimental

3 days of prepared meals with fasting on the final day. On final day, participants will return to study site and drink a prepared blended spinach smoothie and be provided a breakfast meal.

干预措施: Breakfast (Dietary Supplement)

3d Diet+Spinach Smoothie+Breakfast

Experimental

3 days of prepared meals with fasting on the final day. On final day, participants will return to study site and drink a prepared blended spinach smoothie and be provided a breakfast meal.

干预措施: Spinach smoothie (Dietary Supplement)

5d Diet+Spinach Smoothie+Breakfast

Experimental

5 days of prepared meals with fasting on the final day. On final day, participants will return to the study site and drink a prepared blended spinach smoothie and be provided a breakfast meal.

干预措施: Breakfast (Dietary Supplement)

5d Diet+Spinach Smoothie+Breakfast

Experimental

5 days of prepared meals with fasting on the final day. On final day, participants will return to the study site and drink a prepared blended spinach smoothie and be provided a breakfast meal.

干预措施: Spinach smoothie (Dietary Supplement)

3d Diet+Kale Smoothie+Breakfast

Experimental

3 days of prepared meals with fasting on the final day. On the final day, participants will return to the study site and drink a prepared kale smoothie and be provided a breakfast meal.

干预措施: Breakfast (Dietary Supplement)

3d Diet+Breakfast

Experimental

3 days of prepared meals with fasting on the final day. On final day, participants will return to the study site and be provided a breakfast meal.

干预措施: Breakfast (Dietary Supplement)

3d Diet+Sodium Oxalate Drink+Breakfast

Experimental

3 days of prepared meals with fasting on the final day. On final day, participants will return to the study site and drink a prepared sodium oxalate drink and be provided a breakfast meal.

干预措施: Breakfast (Dietary Supplement)

3d Diet+Sodium Oxalate Drink+Breakfast

Experimental

3 days of prepared meals with fasting on the final day. On final day, participants will return to the study site and drink a prepared sodium oxalate drink and be provided a breakfast meal.

干预措施: Sodium oxalate drink (Dietary Supplement)

3d Diet+Spinach Smoothie+Breakfast w/ 24 Hr Urine

Experimental

3 days of prepared meals with fasting on the final day. On final day, participants will return to the study site and drink a blended spinach smoothie and be provided a breakfast meal.

干预措施: Breakfast (Dietary Supplement)

3d Diet+Spinach Smoothie+Breakfast w/ 24 Hr Urine

Experimental

3 days of prepared meals with fasting on the final day. On final day, participants will return to the study site and drink a blended spinach smoothie and be provided a breakfast meal.

干预措施: Spinach smoothie (Dietary Supplement)

结局指标

主要结局

Change in monocyte cellular energetics after 5 hours

时间窗: 0 hours - 5 hours

Cellular bioenergetics (oxygen consumption rate) will be measured in isolated monocytes from human blood using a Seahorse XF Analyzer machine. Monocyte cellular bioenergetics will be measured before and after consuming a spinach smoothie (pre- and post-loads; Time 0 hours and 5 hours) to assess a change in monocyte cellular energetics after 5 hours.

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

Tanecia Mitchell, PhD

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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