Dietary Oxalate and Immune Cell Function

NCT ID: NCT03877276

Last Updated: 2025-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-21

Study Completion Date

2027-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Kidney Stone

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Breakfast

Intervention Type DIETARY_SUPPLEMENT

a prepared meal consisting of pastry and 2 cooked egg whites

Spinach smoothie

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Breakfast

Intervention Type DIETARY_SUPPLEMENT

a prepared meal consisting of pastry and 2 cooked egg whites

Spinach smoothie

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Breakfast

Intervention Type DIETARY_SUPPLEMENT

a prepared meal consisting of pastry and 2 cooked egg whites

Kale smoothie

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Breakfast

Intervention Type DIETARY_SUPPLEMENT

a prepared meal consisting of pastry and 2 cooked egg whites

V spinach smoothie

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Breakfast

Intervention Type DIETARY_SUPPLEMENT

a prepared meal consisting of pastry and 2 cooked egg whites

Blended smoothie

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Breakfast

Intervention Type DIETARY_SUPPLEMENT

a prepared meal consisting of pastry and 2 cooked egg whites

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.

Group Type EXPERIMENTAL

Breakfast

Intervention Type DIETARY_SUPPLEMENT

a prepared meal consisting of pastry and 2 cooked egg whites

Sodium oxalate drink

Intervention Type DIETARY_SUPPLEMENT

a prepared sodium oxalate drink

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.

Group Type EXPERIMENTAL

Breakfast

Intervention Type DIETARY_SUPPLEMENT

a prepared meal consisting of pastry and 2 cooked egg whites

Spinach smoothie

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Breakfast

a prepared meal consisting of pastry and 2 cooked egg whites

Intervention Type DIETARY_SUPPLEMENT

Spinach smoothie

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

Intervention Type DIETARY_SUPPLEMENT

Kale smoothie

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

Intervention Type DIETARY_SUPPLEMENT

Blended smoothie

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Sodium oxalate drink

a prepared sodium oxalate drink

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Tanecia Mitchell, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tanecia Mitchell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Kumar P, Patel M, Oster RA, Yarlagadda V, Ambrosetti A, Assimos DG, Mitchell T. Dietary Oxalate Loading Impacts Monocyte Metabolism and Inflammatory Signaling in Humans. Front Immunol. 2021 Feb 25;12:617508. doi: 10.3389/fimmu.2021.617508. eCollection 2021.

Reference Type DERIVED
PMID: 33732242 (View on PubMed)

Other Identifiers

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F151123009

Identifier Type: -

Identifier Source: org_study_id

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