Effect of Cola on Urinary Stone Risk Factors

May 5, 2016 updated by: Kenneth Ogan, MD, Emory University
Examine the effects of cola on risks of kidney stones

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective crossover study examining the risks of cola on stone risk factors.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • urolithiasis, healthy volunteer

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cola beverage
Subjects will be given 500cc of Cola twice daily.
Drug: Cola beverage
Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.There will be a three weeks interval before crossover to the other treatment arm.
Placebo Comparator: Deionized water
Subjects will be given 500cc of deionized water.
Drug: Deionized water
Subjects will be given 500cc of deionized water to be ingested twice daily with breakfast and dinner for three weeks while on a metabolic diet. There will be a three weeks interval before crossover to the other treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Plasma and Urine Parameters
Time Frame: at the end of each 6-day intervention in Cola and Water Phase

The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:

Plasma Parameters:

CA (mg per dL) GLU (mg per dL) BUN (mg per dL) Cr (mg per dL) Prot (mg per dL) ALB (mg per dL)

Urine Parameters:

uCa (mg per dL) uMg (mg per dL) uP (mg per dL) uCr (mg per dL) uCit (mg per dL) uOx (mg per dL) uUA (mg per dL)

The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).

measure of dispersion was standard deviation.
at the end of each 6-day intervention in Cola and Water Phase
The Plasma and Urine Parameters
Time Frame: at the end of 6-day intervention of Cola and water phase

The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:

Plasma Parameters:

Na (mEq per L) K (mEq per L) CL (mEq per L) CO2(mEq per L) AG (mEq per L)

The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).

measure of dispersion was standard deviation.
at the end of 6-day intervention of Cola and water phase
The Plasma Osmolarity
Time Frame: at the end of 6-day intervention of cola and water phase

The Plasma osmolarity that were assessed at the end of cola and water (arms) phase:

Plasma Parameters:

OSM (mOsm/L)

The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).

measure of dispersion was standard deviation.
at the end of 6-day intervention of cola and water phase
The Plasma and Urine Parameters
Time Frame: at the end of 6-day intervention of Cola and water phase

The Urine Parameters that were assessed at the end of cola and water (arms) phase:

Urine Parameters:

uNa (mEq per d) uK (mEq per d)

The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).

measure of dispersion was standard deviation.
at the end of 6-day intervention of Cola and water phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Urine Volume
Time Frame: at the end of each 6-day intervention in Cola and Water Phase

The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:

Urine Parameters:

Total Urine Volume (mL/day)

The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).

measure of dispersion was standard deviation.
at the end of each 6-day intervention in Cola and Water Phase
Urinary pH
Time Frame: at the end of each 6-day intervention in Cola and Water Phase

The Urine pH that were assessed at the end of cola and water (arms) phase The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).

measure of dispersion was standard deviation.
at the end of each 6-day intervention in Cola and Water Phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (Estimate)

February 9, 2006

Study Record Updates

Last Update Posted (Estimate)

June 8, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0133-2003
  • GCRC#2403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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