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Clinical Trials/NCT03348228
NCT03348228CompletedNot Applicable

Effect of Hydroxycitrate on Urine Chemistry

NYU Langone Health1 site in 1 country18 target enrollmentStarted: October 4, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
1
Primary Endpoint
changes in urinary excretion of citrate

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • Not provided

Arms & Interventions

Control Group

Placebo Comparator

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

Intervention: Hydroxycitrate (HCA) (Dietary Supplement)

Calcium Stone Formers

Active Comparator

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

Intervention: Hydroxycitrate (HCA) (Dietary Supplement)

Outcomes

Primary Outcomes

changes in urinary excretion of citrate

Time Frame: 7 Days

Paired t-tests will be performed to compare any changes in citrate before and after the intervention.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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