Effect of Hydroxycitrate on Urine Chemistry

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03348228

Collaborator

(none)

Enrollment

Location

Arms

26.4

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrolithiasis	Dietary Supplement: Hydroxycitrate (HCA)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Hydroxycitrate on Urine Chemistry

Actual Study Start Date :

Oct 4, 2018

Actual Primary Completion Date :

Dec 15, 2020

Actual Study Completion Date :

Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Group 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) 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).
Active Comparator: Calcium Stone Formers 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) 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).

Arm

Intervention/Treatment

Placebo Comparator: Control Group

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)

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).

Active Comparator: Calcium Stone Formers

Dietary Supplement: Hydroxycitrate (HCA)

Outcome Measures

Primary Outcome Measures

changes in urinary excretion of citrate [7 Days]
Paired t-tests will be performed to compare any changes in citrate before and after the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: David Goldfarb, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03348228

Other Study ID Numbers:

17-00147

First Posted:

Nov 20, 2017

Last Update Posted:

Jan 26, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by NYU Langone Health

Hydroxycitrate Supplements

Additional relevant MeSH terms:

Nephrolithiasis

Kidney Calculi

Study Results

No Results Posted as of Jan 26, 2022