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Dietary Oxalate Intake for Kidney Stone Prevention

N/A

Waitlist Available

Led By Tanecia Mitchell, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 70 years

Mentally competent adults who are able to read and comprehend the consent form, written in English

Must not have

Any medical disorder that could influence absorption or excretion of oxalate

Mentally incompetent adults who are unable to read or comprehend the consent form, written in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 hours - 5 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well the body processes oxalate after eating, which is found in some leafy greens and other foods.

Who is the study for?

This trial is for mentally competent adults aged 18-70, with a BMI of 19-27, who don't use tobacco or vigorous exercise during the study. They must understand English consent forms and have normal blood tests. It's not for pregnant individuals, those on medications/supplements, with medical problems or history of kidney stones.

What is being tested?

The study is testing how different drinks (kale smoothie, spinach smoothie, sodium oxalate drink) affect immune cell function in healthy people by looking at mitochondrial function in white blood cells and platelets after consuming dietary oxalate.

What are the potential side effects?

Since this trial involves dietary intake rather than medication, side effects may be minimal but could include digestive discomfort from the smoothies or changes in bowel habits due to high oxalate levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I can read and understand English and am mentally capable of making my own decisions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that affects how my body absorbs or gets rid of oxalate.

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I am able to understand and consent to the study on my own.

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I have had kidney stones in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 hours - 5 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 hours - 5 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 hours - 5 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in monocyte cellular energetics after 5 hours

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: 5d Diet+Spinach Smoothie+BreakfastExperimental Treatment2 Interventions

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.

Group II: 3d Diet+V Spinach Smoothie+BreakfastExperimental Treatment2 Interventions

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.

Group III: 3d Diet+Spinach Smoothie+Breakfast w/ 24 Hr UrineExperimental Treatment2 Interventions

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.

Group IV: 3d Diet+Spinach Smoothie+BreakfastExperimental Treatment2 Interventions

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.

Group V: 3d Diet+Sodium Oxalate Drink+BreakfastExperimental Treatment2 Interventions

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.

Group VI: 3d Diet+Kale Smoothie+BreakfastExperimental Treatment2 Interventions

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.

Group VII: 3d Diet+BreakfastExperimental Treatment1 Intervention

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.

Group VIII: 3d Diet+Blended Smoothie+BreakfastExperimental Treatment2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Breakfast

2015

Completed Phase 3

~310

0 / 5Eligibility criteria met