Dietary Oxalate and Immune Cell Function

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Kidney Stone

Treatments: Dietary Supplement: Kale smoothie; Dietary Supplement: Blended smoothie; Dietary Supplement: Sodium oxalate drink; Dietary Supplement: V spinach smoothie; Dietary Supplement: Spinach smoothie; Dietary Supplement: Breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT03877276

F151123009

Details and patient eligibility

About

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

Full 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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 8 patient groups

3d Diet+Spinach Smoothie+Breakfast

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Breakfast

Dietary Supplement: Spinach smoothie

5d Diet+Spinach Smoothie+Breakfast

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Breakfast

Dietary Supplement: Spinach smoothie

3d Diet+Kale Smoothie+Breakfast

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Breakfast

Dietary Supplement: Kale smoothie

3d Diet+V Spinach Smoothie+Breakfast

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Breakfast

Dietary Supplement: V spinach smoothie

3d Diet+Blended Smoothie+Breakfast

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Breakfast

Dietary Supplement: Blended smoothie

3d Diet+Breakfast

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Breakfast

3d Diet+Sodium Oxalate Drink+Breakfast

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Breakfast

Dietary Supplement: Sodium oxalate drink

3d Diet+Spinach Smoothie+Breakfast w/ 24 Hr Urine

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Breakfast

Dietary Supplement: Spinach smoothie