Dietary Oxalate and Immune Cell Function

June 2, 2026 updated by: Tanecia Mitchell, PhD, University of Alabama at Birmingham
The purpose of this study is to evaluate mitochondrial function in white blood cells and platelets from healthy individuals following dietary oxalate intake.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3d Diet+Spinach Smoothie+Breakfast
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.
Dietary supplement: Breakfast
a prepared meal consisting of pastry and 2 cooked egg whites
Dietary supplement: Spinach smoothie
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and spinach
Experimental: 5d Diet+Spinach Smoothie+Breakfast
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.
Dietary supplement: Breakfast
a prepared meal consisting of pastry and 2 cooked egg whites
Dietary supplement: Spinach smoothie
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and spinach
Experimental: 3d Diet+Kale Smoothie+Breakfast
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.
Dietary supplement: Breakfast
a prepared meal consisting of pastry and 2 cooked egg whites
Dietary supplement: Kale smoothie
prepared blended kale smoothie, consisting of banana, avocado, orange juice, and kale
Experimental: 3d Diet+V Spinach Smoothie+Breakfast
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.
Dietary supplement: Breakfast
a prepared meal consisting of pastry and 2 cooked egg whites
Dietary supplement: V spinach smoothie
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and a varying amount (low, medium, high) of spinach
Experimental: 3d Diet+Blended Smoothie+Breakfast
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.
Dietary supplement: Breakfast
a prepared meal consisting of pastry and 2 cooked egg whites
Dietary supplement: Blended smoothie
a prepared blended smoothie, consisting of banana, avocado, and orange juice
Experimental: 3d Diet+Breakfast
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.
Dietary supplement: Breakfast
a prepared meal consisting of pastry and 2 cooked egg whites
Experimental: 3d Diet+Sodium Oxalate Drink+Breakfast
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.
Dietary supplement: Breakfast
a prepared meal consisting of pastry and 2 cooked egg whites
Dietary supplement: Sodium oxalate drink
a prepared sodium oxalate drink
Experimental: 3d Diet+Spinach Smoothie+Breakfast w/ 24 Hr Urine
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.
Dietary supplement: Breakfast
a prepared meal consisting of pastry and 2 cooked egg whites
Dietary supplement: Spinach smoothie
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and spinach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 hours - 5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Tanecia Mitchell, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2016

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F151123009
  • UAB - Urology (Other Identifier: UAB - Urology)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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