Kidney Stone
Conditions
Keywords
urolithiasis, cola
Brief summary
Examine the effects of cola on risks of kidney stones
Detailed description
Prospective crossover study examining the risks of cola on stone risk factors.
Interventions
DRUGCola 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.
DRUGDeionized 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
Sponsors
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* urolithiasis, healthy volunteer
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Plasma and Urine Parameters | 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. |
| The Plasma Osmolarity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Urine Volume | 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. |
| Urinary pH | 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. |
Countries
United States
Participant flow
Recruitment details
Recruited patients of Emory University Department of Urology
Pre-assignment details
Normal subjects and calcium oxalate stone-formers were included.
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Cola First, Then Water |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 9 Participants |
| Study participants Calcium oxalate stone- formers | 3 participants |
| Study participants Normal subjects | 10 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
The Plasma and Urine Parameters
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.
Time frame: at the end of each 6-day intervention in Cola and Water Phase
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cola | The Plasma and Urine Parameters | Mean Plasma Glucose | 92.8 mg per dL | Standard Deviation 9 |
| Cola | The Plasma and Urine Parameters | Urinary Magnesium | 94.6 mg per dL | Standard Deviation 43.7 |
| Cola | The Plasma and Urine Parameters | Plasma Proteins | 6800 mg per dL | Standard Deviation 500 |
| Cola | The Plasma and Urine Parameters | Urinary Phosphets | 720.7 mg per dL | Standard Deviation 224.1 |
| Cola | The Plasma and Urine Parameters | blood urea nitrogen | 10.1 mg per dL | Standard Deviation 4.5 |
| Cola | The Plasma and Urine Parameters | Urinary Creatinine | 1620.1 mg per dL | Standard Deviation 699 |
| Cola | The Plasma and Urine Parameters | Plasma Calcium | 9.1 mg per dL | Standard Deviation 0.3 |
| Cola | The Plasma and Urine Parameters | Urinary Citrate | 475.9 mg per dL | Standard Deviation 240.6 |
| Cola | The Plasma and Urine Parameters | Plasma Creatinine | 0.9 mg per dL | Standard Deviation 0.2 |
| Cola | The Plasma and Urine Parameters | Urinary Oxalates | 39.7 mg per dL | Standard Deviation 25.6 |
| Cola | The Plasma and Urine Parameters | Plasma Albumin | 3700 mg per dL | Standard Deviation 300 |
| Cola | The Plasma and Urine Parameters | Uric acids | 555.3 mg per dL | Standard Deviation 183.1 |
| Cola | The Plasma and Urine Parameters | Urinary Calcium | 124.3 mg per dL | Standard Deviation 74.5 |
| Water | The Plasma and Urine Parameters | Uric acids | 646.4 mg per dL | Standard Deviation 272 |
| Water | The Plasma and Urine Parameters | Plasma Proteins | 6800 mg per dL | Standard Deviation 500 |
| Water | The Plasma and Urine Parameters | Plasma Albumin | 3700 mg per dL | Standard Deviation 300 |
| Water | The Plasma and Urine Parameters | Plasma Calcium | 9.0 mg per dL | Standard Deviation 0.2 |
| Water | The Plasma and Urine Parameters | Mean Plasma Glucose | 95.2 mg per dL | Standard Deviation 15.7 |
| Water | The Plasma and Urine Parameters | blood urea nitrogen | 11.1 mg per dL | Standard Deviation 5 |
| Water | The Plasma and Urine Parameters | Plasma Creatinine | 2.1 mg per dL | Standard Deviation 2.9 |
| Water | The Plasma and Urine Parameters | Urinary Calcium | 146.4 mg per dL | Standard Deviation 86.9 |
| Water | The Plasma and Urine Parameters | Urinary Magnesium | 106.8 mg per dL | Standard Deviation 49.9 |
| Water | The Plasma and Urine Parameters | Urinary Phosphets | 739.6 mg per dL | Standard Deviation 320.5 |
| Water | The Plasma and Urine Parameters | Urinary Creatinine | 1950.1 mg per dL | Standard Deviation 1057.1 |
| Water | The Plasma and Urine Parameters | Urinary Citrate | 727.7 mg per dL | Standard Deviation 666.2 |
| Water | The Plasma and Urine Parameters | Urinary Oxalates | 34.7 mg per dL | Standard Deviation 21 |
Primary
The Plasma and Urine Parameters
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.
Time frame: at the end of 6-day intervention of Cola and water phase
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cola | The Plasma and Urine Parameters | Plasma Potassium | 3.8 mEq/L | Standard Deviation 0.2 |
| Cola | The Plasma and Urine Parameters | Plasma CO2 | 26.1 mEq/L | Standard Deviation 2 |
| Cola | The Plasma and Urine Parameters | Plasma Chlorides | 104.8 mEq/L | Standard Deviation 2.3 |
| Cola | The Plasma and Urine Parameters | Plasma AG | 7.3 mEq/L | Standard Deviation 1.2 |
| Cola | The Plasma and Urine Parameters | Plasma sodium | 138.3 mEq/L | Standard Deviation 2.5 |
| Water | The Plasma and Urine Parameters | Plasma AG | 7.3 mEq/L | Standard Deviation 1.6 |
| Water | The Plasma and Urine Parameters | Plasma sodium | 139.1 mEq/L | Standard Deviation 2.3 |
| Water | The Plasma and Urine Parameters | Plasma Potassium | 3.9 mEq/L | Standard Deviation 0.4 |
| Water | The Plasma and Urine Parameters | Plasma Chlorides | 105.2 mEq/L | Standard Deviation 3 |
| Water | The Plasma and Urine Parameters | Plasma CO2 | 26.4 mEq/L | Standard Deviation 2.4 |
Primary
The Plasma and Urine Parameters
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.
Time frame: at the end of 6-day intervention of Cola and water phase
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cola | The Plasma and Urine Parameters | Urinary sodium | 139.9 mEq per d | Standard Deviation 40 |
| Cola | The Plasma and Urine Parameters | Urinary Potassium | 49.3 mEq per d | Standard Deviation 31.4 |
| Water | The Plasma and Urine Parameters | Urinary sodium | 103.9 mEq per d | Standard Deviation 43.5 |
| Water | The Plasma and Urine Parameters | Urinary Potassium | 41.4 mEq per d | Standard Deviation 17.1 |
Primary
The Plasma Osmolarity
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.
Time frame: at the end of 6-day intervention of cola and water phase
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cola | The Plasma Osmolarity | 276.5 mOsm/L | Standard Deviation 4.8 |
| Water | The Plasma Osmolarity | 277.5 mOsm/L | Standard Deviation 5 |
Secondary
Total Urine Volume
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.
Time frame: at the end of each 6-day intervention in Cola and Water Phase
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cola | Total Urine Volume | 2521.3 mL/day | Standard Deviation 1152.6 |
| Water | Total Urine Volume | 2266.2 mL/day | Standard Deviation 811 |
Secondary
Urinary pH
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.
Time frame: at the end of each 6-day intervention in Cola and Water Phase
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cola | Urinary pH | 6.0 pH | Standard Deviation 0.6 |
| Water | Urinary pH | 6.0 pH | Standard Deviation 0.5 |