Dietary Oxalate and Immune Cell Function

Kidney Stone Clinical Trial

Official title:

Dietary Oxalate and Immune Cell Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03877276
• Other study ID #: F151123009
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2016
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone

Intervention

Dietary Supplement:
• Breakfast
a prepared meal consisting of pastry and 2 cooked egg whites
• Spinach smoothie
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and spinach
• Kale smoothie
prepared blended kale smoothie, consisting of banana, avocado, orange juice, and kale
• Blended smoothie
a prepared blended smoothie, consisting of banana, avocado, and orange juice
• V spinach smoothie
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and a varying amount (low, medium, high) of spinach
• Sodium oxalate drink
a prepared sodium oxalate drink

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in monocyte cellular energetics after 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.	0 hours - 5 hours