Effect of Hydroxycitrate on Urine Chemistry

Study Overview
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Brief Summary
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Hydroxycitrate (HCA) is a compound extracted from the fruit, Garcinia Cambogia. Hydroxycitrate supplements are available over the counter and are primarily promoted as a weight loss supplement. There has been recent evidence that hydroxycitrate is a potent inhibitor of calcium oxalate crystal growth and can lead to the dissolution of the crystals. The purpose of this research study is to study the effect of Hydroxycitrate (HCA) supplements on HCA urinary excretion and on urine chemistries in kidney stone formers and normal subjects.

Official Title
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Effect of Hydroxycitrate on Urine Chemistry

Conditions
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Nephrolithiasis

Intervention / Treatment
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* Dietary Supplement: Hydroxycitrate (HCA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stone formers group: Established diagnosis of recurrent calcium stone formers Ages between 18 and 80 Subjects must be able to read and follow instructions clearly and able to do 24 hour urine collections. Subjects must be voluntarily willing and able to sign an informed consent form. Control Group: In addition to b, c and d above, subjects must not have any known kidney disease or family history of renal stones. Inclusion would be based on information provided by participants. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Participants willrecord a self-selected diet for 3 days and then perform two 24-hour urine collections on the last 2 days of this diet. HCA will be administered afterwards to both groups (see methods below) for 7 days | Dietary Supplement: Hydroxycitrate (HCA)<br>* Hydroxycitrate supplements are available over the counter and are primarily promoted as a weight loss supplement. Each subject will be given 42 capsules of Swanson super citrimax (hydroxycitrate) Details of the product are provided above. The subjects will be asked to take the capsules over a seven period (6 capsules per day).<br>|
| Active Comparator: Calcium Stone Formers<br>Participants willrecord a self-selected diet for 3 days and then perform two 24-hour urine collections on the last 2 days of this diet. HCA will be administered afterwards to both groups (see methods below) for 7 days | Dietary Supplement: Hydroxycitrate (HCA)<br>* Hydroxycitrate supplements are available over the counter and are primarily promoted as a weight loss supplement. Each subject will be given 42 capsules of Swanson super citrimax (hydroxycitrate) Details of the product are provided above. The subjects will be asked to take the capsules over a seven period (6 capsules per day).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in urinary excretion of citrate | Paired t-tests will be performed to compare any changes in citrate before and after the intervention. | 7 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydroxycitrate Supplements