Dietary Oxalate and Immune Cell Function
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2016
CompletedFirst Submitted
Initial submission to the registry
March 5, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
June 9, 2025
June 1, 2025
9.9 years
March 5, 2019
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
0 hours - 5 hours
Study Arms (8)
3d Diet+Spinach Smoothie+Breakfast
EXPERIMENTAL3 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.
5d Diet+Spinach Smoothie+Breakfast
EXPERIMENTAL5 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+Kale Smoothie+Breakfast
EXPERIMENTAL3 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+V Spinach Smoothie+Breakfast
EXPERIMENTAL3 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+Blended Smoothie+Breakfast
EXPERIMENTAL3 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+Breakfast
EXPERIMENTAL3 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+Sodium Oxalate Drink+Breakfast
EXPERIMENTAL3 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+Spinach Smoothie+Breakfast w/ 24 Hr Urine
EXPERIMENTAL3 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.
Interventions
a prepared meal consisting of pastry and 2 cooked egg whites
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and spinach
prepared blended kale smoothie, consisting of banana, avocado, orange juice, and kale
a prepared blended smoothie, consisting of banana, avocado, and orange juice
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and a varying amount (low, medium, high) of spinach
a prepared sodium oxalate drink
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Related Publications (1)
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.
PMID: 33732242DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tanecia Mitchell, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 5, 2019
First Posted
March 15, 2019
Study Start
July 21, 2016
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
June 9, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share