search
Back to results

Dietary Oxalate and Immune Cell Function

Primary Purpose

Kidney Stone

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breakfast
Spinach smoothie
Kale smoothie
Blended smoothie
V spinach smoothie
Sodium oxalate drink
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone focused on measuring dietary oxalate, diet therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

3d Diet+Spinach Smoothie+Breakfast

5d Diet+Spinach Smoothie+Breakfast

3d Diet+Kale Smoothie+Breakfast

3d Diet+V Spinach Smoothie+Breakfast

3d Diet+Blended Smoothie+Breakfast

3d Diet+Breakfast

3d Diet+Sodium Oxalate Drink+Breakfast

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

Arm 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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2019
Last Updated
August 7, 2023
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT03877276
Brief Title
Dietary Oxalate and Immune Cell Function
Official Title
Dietary Oxalate and Immune Cell Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 21, 2016 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
dietary oxalate, diet therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3d Diet+Spinach Smoothie+Breakfast
Arm Type
Experimental
Arm 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.
Arm Title
5d Diet+Spinach Smoothie+Breakfast
Arm Type
Experimental
Arm 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.
Arm Title
3d Diet+Kale Smoothie+Breakfast
Arm Type
Experimental
Arm 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.
Arm Title
3d Diet+V Spinach Smoothie+Breakfast
Arm Type
Experimental
Arm 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.
Arm Title
3d Diet+Blended Smoothie+Breakfast
Arm Type
Experimental
Arm 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.
Arm Title
3d Diet+Breakfast
Arm Type
Experimental
Arm 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.
Arm Title
3d Diet+Sodium Oxalate Drink+Breakfast
Arm Type
Experimental
Arm 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.
Arm Title
3d Diet+Spinach Smoothie+Breakfast w/ 24 Hr Urine
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Breakfast
Intervention Description
a prepared meal consisting of pastry and 2 cooked egg whites
Intervention Type
Dietary Supplement
Intervention Name(s)
Spinach smoothie
Intervention Description
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and spinach
Intervention Type
Dietary Supplement
Intervention Name(s)
Kale smoothie
Intervention Description
prepared blended kale smoothie, consisting of banana, avocado, orange juice, and kale
Intervention Type
Dietary Supplement
Intervention Name(s)
Blended smoothie
Intervention Description
a prepared blended smoothie, consisting of banana, avocado, and orange juice
Intervention Type
Dietary Supplement
Intervention Name(s)
V spinach smoothie
Intervention Description
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and a varying amount (low, medium, high) of spinach
Intervention Type
Dietary Supplement
Intervention Name(s)
Sodium oxalate drink
Intervention Description
a prepared sodium oxalate drink
Primary Outcome Measure Information:
Title
Change in monocyte cellular energetics after 5 hours
Description
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.
Time Frame
0 hours - 5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanecia Mitchell, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33732242
Citation
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.
Results Reference
derived

Learn more about this trial

Dietary Oxalate and Immune Cell Function

We'll reach out to this number within 24 hrs