Kidney StoneNCT03877276
Dietary Oxalate and Immune Cell Function
A study testing Breakfast, Spinach smoothie and Kale smoothie in people with Kidney Stone, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to evaluate mitochondrial function in white blood cells and platelets from healthy individuals following dietary oxalate intake. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Breakfast, Spinach smoothie and Kale smoothie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2016to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
The purpose of this study is to evaluate mitochondrial function in white blood cells and platelets from healthy individuals following dietary oxalate intake.
Read the 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.
- Conditions
- Kidney Stone
- Being tested
- Breakfast, Spinach smoothie, Kale smoothie, Blended smoothie, V spinach smoothie
- Keywords
- dietary oxalate, diet therapy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreakfastDietary supplement
a prepared meal consisting of pastry and 2 cooked egg whites
Spinach smoothieDietary supplement
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and spinach
Kale smoothieDietary supplement
prepared blended kale smoothie, consisting of banana, avocado, orange juice, and kale
Blended smoothieDietary supplement
a prepared blended smoothie, consisting of banana, avocado, and orange juice
V spinach smoothieDietary supplement
a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and a varying amount (low, medium, high) of spinach
Sodium oxalate drinkDietary supplement
a prepared sodium oxalate drink
| Study group | Role | What they receive |
|---|---|---|
| 3d Diet+Spinach Smoothie+Breakfast | Experimental | 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. Receives: Dietary Supplement: Breakfast; Dietary Supplement: Spinach smoothie |
| 5d Diet+Spinach Smoothie+Breakfast | Experimental | 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. Receives: Dietary Supplement: Breakfast; Dietary Supplement: Spinach smoothie |
| 3d Diet+Kale Smoothie+Breakfast | Experimental | 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. Receives: Dietary Supplement: Breakfast; Dietary Supplement: Kale smoothie |
| 3d Diet+V Spinach Smoothie+Breakfast | Experimental | 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. Receives: Dietary Supplement: Breakfast; Dietary Supplement: V spinach smoothie |
| 3d Diet+Blended Smoothie+Breakfast | Experimental | 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. Receives: Dietary Supplement: Breakfast; Dietary Supplement: Blended smoothie |
| 3d Diet+Breakfast | Experimental | 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. Receives: Dietary Supplement: Breakfast |
| 3d Diet+Sodium Oxalate Drink+Breakfast | Experimental | 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. Receives: Dietary Supplement: Breakfast; Dietary Supplement: Sodium oxalate drink |
| 3d Diet+Spinach Smoothie+Breakfast w/ 24 Hr Urine | Experimental | 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. Receives: Dietary Supplement: Breakfast; Dietary Supplement: Spinach smoothie |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 hours - 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start21 Jul 2016
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanecia Mitchell, PhD, University of Alabama at Birmingham
- Investigators
- Tanecia Mitchell, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877276
- Sponsor's protocol ID
- F151123009
- Other IDs
- UAB - Urology
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2019
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33732242
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Oxalate and Immune Cell Function
- ClinicalTrials.gov ID
- NCT03877276
- Acronym / sponsor ID
- F151123009
- Conditions
- Kidney Stone
- Keywords
- dietary oxalate, diet therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 21 Jul 2016 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 3d Diet+Spinach Smoothie+Breakfast | Experimental | Dietary Supplement: Breakfast, Dietary Supplement: Spinach smoothie3 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 | Experimental | Dietary Supplement: Breakfast, Dietary Supplement: Spinach smoothie5 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 | Experimental | Dietary Supplement: Breakfast, Dietary Supplement: Kale smoothie3 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 | Experimental | Dietary Supplement: Breakfast, Dietary Supplement: V spinach smoothie3 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 | Experimental | Dietary Supplement: Breakfast, Dietary Supplement: Blended smoothie3 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 | Experimental | Dietary Supplement: Breakfast3 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 | Experimental | Dietary Supplement: Breakfast, Dietary Supplement: Sodium oxalate drink3 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 | Experimental | Dietary Supplement: Breakfast, Dietary Supplement: Spinach smoothie3 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfasta prepared meal consisting of pastry and 2 cooked egg whites | Dietary supplement | 3d Diet+Blended Smoothie+Breakfast, 3d Diet+Breakfast, 3d Diet+Kale Smoothie+Breakfast, 3d Diet+Sodium Oxalate Drink+Breakfast, 3d Diet+Spinach Smoothie+Breakfast, 3d Diet+Spinach Smoothie+Breakfast w/ 24 Hr Urine, 3d Diet+V Spinach Smoothie+Breakfast, 5d Diet+Spinach Smoothie+Breakfast |
| Spinach smoothiea prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and spinach | Dietary supplement | 3d Diet+Spinach Smoothie+Breakfast, 3d Diet+Spinach Smoothie+Breakfast w/ 24 Hr Urine, 5d Diet+Spinach Smoothie+Breakfast |
| Kale smoothieprepared blended kale smoothie, consisting of banana, avocado, orange juice, and kale | Dietary supplement | 3d Diet+Kale Smoothie+Breakfast |
| Blended smoothiea prepared blended smoothie, consisting of banana, avocado, and orange juice | Dietary supplement | 3d Diet+Blended Smoothie+Breakfast |
| V spinach smoothiea prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and a varying amount (low, medium, high) of spinach | Dietary supplement | 3d Diet+V Spinach Smoothie+Breakfast |
| Sodium oxalate drinka prepared sodium oxalate drink | Dietary supplement | 3d Diet+Sodium Oxalate Drink+Breakfast |
Primary outcome
Change in monocyte cellular energetics after 5 hours
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 33732242Kumar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanecia Mitchell, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast, Spinach smoothie and Kale smoothie in people with Kidney Stone, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in monocyte cellular energetics after 5 hours (time frame: 0 hours - 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03877276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.