Trial Outcomes & Findings for Effect of Cola on Urinary Stone Risk Factors (NCT NCT00289120)

Last Updated: 2016-06-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

at the end of each 6-day intervention in Cola and Water Phase

Results posted on

2016-06-08

Participant Flow

Recruited patients of Emory University Department of Urology

Normal subjects and calcium oxalate stone-formers were included.

Participant milestones

Participant milestones
Measure	Cola First, Then Water Phase 1: 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 wash-out period before patients entere phase 2 of thre study. Phase 2: Subjects will be given 500cc of deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Cola on Urinary Stone Risk Factors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cola First, Then Water n=13 Participants Phase 1: 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 3-week wash out period before subjects enter phase 2 of the study. Phase 2: Subjects will be given 500 cc of deionized water beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Study participants Normal subjects	10 participants n=5 Participants
Study participants Calcium oxalate stone- formers	3 participants n=5 Participants

PRIMARY outcome

Timeframe: at the end of each 6-day intervention in Cola and Water Phase

Outcome measures

Outcome measures
Measure	Cola n=13 Participants they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.	Water n=13 Participants participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
The Plasma and Urine Parameters Plasma Proteins	6800 mg per dL Standard Deviation 500	6800 mg per dL Standard Deviation 500
The Plasma and Urine Parameters Plasma Albumin	3700 mg per dL Standard Deviation 300	3700 mg per dL Standard Deviation 300
The Plasma and Urine Parameters Plasma Calcium	9.1 mg per dL Standard Deviation 0.3	9.0 mg per dL Standard Deviation 0.2
The Plasma and Urine Parameters Mean Plasma Glucose	92.8 mg per dL Standard Deviation 9	95.2 mg per dL Standard Deviation 15.7
The Plasma and Urine Parameters blood urea nitrogen	10.1 mg per dL Standard Deviation 4.5	11.1 mg per dL Standard Deviation 5.0
The Plasma and Urine Parameters Plasma Creatinine	0.9 mg per dL Standard Deviation 0.2	2.1 mg per dL Standard Deviation 2.9
The Plasma and Urine Parameters Urinary Calcium	124.3 mg per dL Standard Deviation 74.5	146.4 mg per dL Standard Deviation 86.9
The Plasma and Urine Parameters Urinary Magnesium	94.6 mg per dL Standard Deviation 43.7	106.8 mg per dL Standard Deviation 49.9
The Plasma and Urine Parameters Urinary Phosphets	720.7 mg per dL Standard Deviation 224.1	739.6 mg per dL Standard Deviation 320.5
The Plasma and Urine Parameters Urinary Creatinine	1620.1 mg per dL Standard Deviation 699.0	1950.1 mg per dL Standard Deviation 1057.1
The Plasma and Urine Parameters Urinary Citrate	475.9 mg per dL Standard Deviation 240.6	727.7 mg per dL Standard Deviation 666.2
The Plasma and Urine Parameters Urinary Oxalates	39.7 mg per dL Standard Deviation 25.6	34.7 mg per dL Standard Deviation 21.0
The Plasma and Urine Parameters Uric acids	555.3 mg per dL Standard Deviation 183.1	646.4 mg per dL Standard Deviation 272.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cola n=13 Participants they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.	Water n=13 Participants participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
The Plasma and Urine Parameters Plasma sodium	138.3 mEq/L Standard Deviation 2.5	139.1 mEq/L Standard Deviation 2.3
The Plasma and Urine Parameters Plasma Potassium	3.8 mEq/L Standard Deviation 0.2	3.9 mEq/L Standard Deviation 0.4
The Plasma and Urine Parameters Plasma Chlorides	104.8 mEq/L Standard Deviation 2.3	105.2 mEq/L Standard Deviation 3.0
The Plasma and Urine Parameters Plasma CO2	26.1 mEq/L Standard Deviation 2.0	26.4 mEq/L Standard Deviation 2.4
The Plasma and Urine Parameters Plasma AG	7.3 mEq/L Standard Deviation 1.2	7.3 mEq/L Standard Deviation 1.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cola n=13 Participants they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.	Water n=13 Participants participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
The Plasma Osmolarity	276.5 mOsm/L Standard Deviation 4.8	277.5 mOsm/L Standard Deviation 5.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cola n=13 Participants they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.	Water n=13 Participants participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
The Plasma and Urine Parameters Urinary sodium	139.9 mEq per d Standard Deviation 40.0	103.9 mEq per d Standard Deviation 43.5
The Plasma and Urine Parameters Urinary Potassium	49.3 mEq per d Standard Deviation 31.4	41.4 mEq per d Standard Deviation 17.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cola n=13 Participants they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.	Water n=13 Participants participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
Total Urine Volume	2521.3 mL/day Standard Deviation 1152.6	2266.2 mL/day Standard Deviation 811.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cola n=13 Participants they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.	Water n=13 Participants participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
Urinary pH	6.0 pH Standard Deviation 0.6	6.0 pH Standard Deviation 0.5

Adverse Events

Cola Beverage Phase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Deionized Water Drinking Phase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kenneth Ogan

Emory University

Phone: 404-778-4898

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place