Dietary Oxalate and Immune Cell Function

Not Applicable

Active, not recruiting

• Conditions: Kidney Stone
• Interventions: Dietary Supplement: Breakfast; Dietary Supplement: Spinach smoothie; Dietary Supplement: Kale smoothie; Dietary Supplement: Sodium oxalate drink; Dietary Supplement: Blended smoothie; Dietary Supplement: V spinach smoothie

• Registration Number: NCT03877276
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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 Timeline

• Study Start: 2016-07-21
• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-06
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 82

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3d Diet+Spinach Smoothie+Breakfast	Spinach smoothie	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.
3d Diet+Spinach Smoothie+Breakfast	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.
3d Diet+Sodium Oxalate Drink+Breakfast	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.
5d Diet+Spinach Smoothie+Breakfast	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.
3d Diet+Breakfast	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.
3d Diet+Spinach Smoothie+Breakfast w/ 24 Hr Urine	Spinach smoothie	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.
3d Diet+Kale Smoothie+Breakfast	Kale smoothie	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.
5d Diet+Spinach Smoothie+Breakfast	Spinach smoothie	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.
3d Diet+V Spinach Smoothie+Breakfast	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.
3d Diet+Sodium Oxalate Drink+Breakfast	Sodium oxalate drink	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.
3d Diet+Kale Smoothie+Breakfast	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.
3d Diet+Blended Smoothie+Breakfast	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.
3d Diet+Blended Smoothie+Breakfast	Blended smoothie	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.
3d Diet+V Spinach Smoothie+Breakfast	V spinach smoothie	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.
3d Diet+Spinach Smoothie+Breakfast w/ 24 Hr Urine	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 blended spinach smoothie and be provided a breakfast meal.

Primary Outcome Measures

Name	Time	Method
Change in monocyte cellular energetics after 5 hours	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States