Effect of Hydroxycitrate on Urine Chemistry

NCT03348228 | Completed

• 1 other identifier: 17-00147
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrolithiasis

Keywords

Hydroxycitrate Supplements

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Dietary Supplement: Hydroxycitrate (HCA)

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

Dietary Supplement: Hydroxycitrate (HCA)

Interventions

Hydroxycitrate (HCA) DIETARY_SUPPLEMENT

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).

Calcium Stone Formers; Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

hydroxycitric acid

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• David Goldfarb, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: October 4, 2018
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

US (1)