An interventional study of Cola beverage and Deionized water in Kidney Stone, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-08.
Sponsored by Emory University · Not applicable, Interventional, and Health services research
Examine the effects of cola on risks of kidney stones
Prospective crossover study examining the risks of cola on stone risk factors.
598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.
This study's enrollment of 13 is below the median of 90 across 461 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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Subjects will be given 500cc of Cola twice daily.
Drug: Cola beverage
Subjects will be given 500cc of deionized water.
Drug: Deionized water
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.
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
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
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
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
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
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
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
Recruited patients of Emory University Department of Urology
| Milestone | Cola First, Then Water |
|---|---|
| Started | 13 |
| Completed | 13 |
| Not completed | 0 |
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.
| mg per dL | Cola | Water |
|---|---|---|
| Plasma Proteins | 6800 ± 500 | 6800 ± 500 |
| Plasma Albumin | 3700 ± 300 | 3700 ± 300 |
| Plasma Calcium | 9.1 ± 0.3 | 9.0 ± 0.2 |
| Mean Plasma Glucose | 92.8 ± 9 | 95.2 ± 15.7 |
| blood urea nitrogen | 10.1 ± 4.5 | 11.1 ± 5.0 |
| Plasma Creatinine | 0.9 ± 0.2 | 2.1 ± 2.9 |
| Urinary Calcium | 124.3 ± 74.5 | 146.4 ± 86.9 |
| Urinary Magnesium | 94.6 ± 43.7 | 106.8 ± 49.9 |
| Urinary Phosphets | 720.7 ± 224.1 | 739.6 ± 320.5 |
| Urinary Creatinine | 1620.1 ± 699.0 | 1950.1 ± 1057.1 |
| Urinary Citrate | 475.9 ± 240.6 | 727.7 ± 666.2 |
| Urinary Oxalates | 39.7 ± 25.6 | 34.7 ± 21.0 |
| Uric acids | 555.3 ± 183.1 | 646.4 ± 272.0 |
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.
| mEq/L | Water | Cola |
|---|---|---|
| Plasma sodium | 138.3 ± 2.5 | 139.1 ± 2.3 |
| Plasma Potassium | 3.8 ± 0.2 | 3.9 ± 0.4 |
| Plasma Chlorides | 104.8 ± 2.3 | 105.2 ± 3.0 |
| Plasma CO2 | 26.1 ± 2.0 | 26.4 ± 2.4 |
| Plasma AG | 7.3 ± 1.2 | 7.3 ± 1.6 |
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.
| mOsm/L | Water | Cola |
|---|---|---|
| The Plasma Osmolarity | 276.5 ± 4.8 | 277.5 ± 5.0 |
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.
| mL/day | Water | Cola |
|---|---|---|
| Total Urine Volume | 2521.3 ± 1152.6 | 2266.2 ± 811.0 |
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.
| pH | Cola | Water |
|---|---|---|
| Urinary pH | 6.0 ± 0.6 | 6.0 ± 0.5 |
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.
| mEq per d | Water | Cola |
|---|---|---|
| Urinary sodium | 139.9 ± 40.0 | 103.9 ± 43.5 |
| Urinary Potassium | 49.3 ± 31.4 | 41.4 ± 17.1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cola Beverage Phase | — | 0/13 (0%) | 0/13 (0%) |
| Deionized Water Drinking Phase | — | 0/13 (0%) | 0/13 (0%) |
Thirteen subjects, including 10 normal subjects and 3 calcium oxalate stone-formers were enrolled in this prospective cross-over study.
| Age, Categorical(Participants) | Cola First, Then Water |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Cola First, Then Water |
|---|---|
| Female | 4 |
| Male | 9 |
| Study participants(participants) | Cola First, Then Water |
|---|---|
| Normal subjects | 10 |
| Calcium oxalate stone- formers | 3 |
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Emory University