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Active, Not Recruiting

NCT Number: NCT03877276

Dietary Oxalate and Immune Cell Function

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Breakfast

Dietary Supplement

a prepared meal consisting of pastry and 2 cooked egg whites

Spinach smoothie

Dietary Supplement

a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and spinach

Kale smoothie

Dietary Supplement

prepared blended kale smoothie, consisting of banana, avocado, orange juice, and kale

Blended smoothie

Dietary Supplement

a prepared blended smoothie, consisting of banana, avocado, and orange juice

V spinach smoothie

Dietary Supplement

a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and a varying amount (low, medium, high) of spinach

Sodium oxalate drink

Dietary Supplement

a prepared sodium oxalate drink

Primary outcomes

  1. Change in monocyte cellular energetics after 5 hours

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2016
Primary completion
2029
Study completion
2029
First posted
Mar 15, 2019
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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