Healthy
Conditions
Brief summary
This study is a prospective study looking at healthy adults who will have urine collected at 4 set times throughout the course of the day. On Day 2, 3, and 4 subjects will drink a bottle of water containing True lemon and on days 2 and 3 double the amount of fluid intake from Day 1. On day 4 the subject will collect urine samples at 4 set times throughout the day. The pH of all of the urine samples will be checked with a urine dipstick and the samples will be sent to Litholink Lab for electrolyte composition analysis.
Detailed description
20 subjects will be recruited and consented in the Urology Clinic office. Subjects will complete a questionnaire asking about weight, height, history of kidney stones, whether they are on any diuretics, medications that alter urine chemistries, or special diets. BMI will be calculated. Day 1 will begin at 5p.m. on the day before first morning void is collected. The subjects will collect a spot urine sample on the first void at home, then at 9-10AM, 1-2 PM and 4-5PM. They will be provided 4 sterile urine cups labeled for the different timed collection marked at the 20-30 ml line to indicate how much urine should be collected. Subjects will be instructed to refrigerate their first voids.The 2nd, 3rd and 4th void samples will be collected in the office during the designated times, and given to study personnel. The subjects will record the time of each void, the time given to the study representative, the times they eat, and their approximate fluid intake on the provided diaries. Subjects will be asked not to void outside of the timed collections. If they do void outside of these times, they will be asked to record the extra times that they void. On Day 2, 3, and 4 the subject will drink a bottle of water with True Lemon after 5pm. On days 3 and 4 the subjects will double their fluid intake using Day 1 as a guide. On Day 4 the subjects will collect 4 urine samples as previously described for Day1. They will be instructed to mix 1 packet of True lemon in one 16.9oz (500 mL) bottle of Poland Spring. All True Lemon packets (True Citrus, 11501 Pocomoke Court Suite D, Baltimore, MD 21220). and Poland Spring (Nestle Waters North America) bottles will be provided to subjects by the research study team. UA dipsticks will be used in office to evaluate for pH and specific gravity. Samples will also be sent to lab for evaluation of chemical composition of creatinine, citrate, and calcium. Electrolytes will be indexed against creatinine to evaluate their concentrations without having a 24-hour void volume amount A sample of citrate-Poland Spring will be sent to Litholink for analysis of Calcium and Citrate for reference.
Interventions
DIETARY_SUPPLEMENTNormal fluid intake without true lemon
16.9oz water with True Lemon
DIETARY_SUPPLEMENTDouble fluid intake plus 3 bottles of water with True Lemon
No intervention
Sponsors
Labcorp Corporation of America Holdings, Inc
Adam Howe, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All subjects will collect 4 urine samples on Day1 and Day 4. On day 2, 3 and 4 all subjects will drink a bottle of water with True Lemon and collect another 4 urine samples on day 4
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult subjects
Exclusion criteria
* Subjects taking diuretics * Subjects who have known kidney disease * Subjects with history of known nephrolithiasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Citrate/Creatinine Ratio | Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm) | Citrate/Cr at 4 voids throughout the day. Pre = baseline fluid intake; Post = increased fluid and citrate supplementation |
| Calcium / Creatinine | Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm) | Ca/Cr at 4 voids throughout the day. Pre = baseline fluid intake; Post = increased fluid and citrate supplementation |
| pH | Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm) | pH at 4 voids throughout the day. Pre = baseline fluid intake; Post |
| Specific Gravity (SG) | Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm) | SG at 4 voids throughout the day. Pre = baseline fluid intake; Post |
| Total Fluid Intake | Over 4 day study period | — |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited from Albany Medical Center Urology clinic. A total of 23 participants were recruited
Pre-assignment details
23 patients were enrolled, but 3 had to be excluded based on study exclusion criteria. 3 patients had a history of nephrolithiasis.
Participants by arm
| Arm | Count |
|---|---|
| Non-Stone Forming Cohort All 23 patients completed both interventions, and were used as their own control for baseline vs increased fluid/citrate intake comparisons in this cross over study.
The same cohort underwent the following 2 periods, and all participants competed both
Period 1: Normal drinking habits and diet. This was for a total of 24 hours (i.e. Day 1). Urine was collected throughout day 1
Period 2: Increased fluid intake and citrate supplement (I.e. day 2-4). Participants all were encouraged to double their baseline fluid intake compared to day 1, and drink 1 bottle of Poland Spring 16.9oz with 1 packet of True lemon per day. Urine was collected throughout day 4. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Non-Stone Forming Cohort | — |
|---|---|---|
| Age, Customized Age >/= 18 | 20 Participants | — |
| BMI | 25.9 kg/m^2 | — |
| Diet Clean | 1 Participants | — |
| Diet Gluten Free | 1 Participants | — |
| Diet Vegetarians | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
| Use of Vitamins | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
Calcium / Creatinine
Ca/Cr at 4 voids throughout the day. Pre = baseline fluid intake; Post = increased fluid and citrate supplementation
Time frame: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm)
Population: Each participant had urine collected at each time listed: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm). Data was collected on the Citrate/Creatinine Ratio at each time period void. Thus, at each time of day, there was an N equivalent to the number of voids across all entire 20 participant cohort. Since it was the same participant providing the void at the different times, the sum of participants does not add to the n in the study population (20).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5pm Void Post | Calcium / Creatinine | 0.162234 Ratio | Standard Deviation 0.114914139 |
| 5p.m. Pre | Calcium / Creatinine | 0.161287 Ratio | Standard Deviation 0.166305391 |
| 1-2 pm Post | Calcium / Creatinine | 0.137398 Ratio | Standard Deviation 0.1035436 |
| 1-2pm Void Pre | Calcium / Creatinine | 0.140431 Ratio | Standard Deviation 0.153463692 |
| 9-10AM Post | Calcium / Creatinine | 0.126269 Ratio | Standard Deviation 0.097422413 |
| 9-10AM Pre | Calcium / Creatinine | 0.111446 Ratio | Standard Deviation 0.072068182 |
| First Void Pre | Calcium / Creatinine | 0.160932 Ratio | Standard Deviation 0.111594912 |
| First Void Post | Calcium / Creatinine | 0.142987 Ratio | Standard Deviation 0.108493894 |
Primary
Citrate/Creatinine Ratio
Citrate/Cr at 4 voids throughout the day. Pre = baseline fluid intake; Post = increased fluid and citrate supplementation
Time frame: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm)
Population: Each participant had urine collected at each time listed: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm). Data was collected on the Citrate/Creatinine Ratio at each time period void. Thus, at each time of day, there was an N equivalent to the number of voids across all entire 20 participant cohort. Since it was the same participant providing the void at the different times, the sum of participants does not add to the n in the study population (20).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5pm Void Post | Citrate/Creatinine Ratio | 0.658644 ratio | Standard Deviation 0.429258801 |
| 5p.m. Pre | Citrate/Creatinine Ratio | 0.584115 ratio | Standard Deviation 0.393029128 |
| 1-2 pm Post | Citrate/Creatinine Ratio | 0.562886 ratio | Standard Deviation 0.309518524 |
| 1-2pm Void Pre | Citrate/Creatinine Ratio | 0.540394 ratio | Standard Deviation 0.332082046 |
| 9-10AM Post | Citrate/Creatinine Ratio | 0.490685 ratio | Standard Deviation 0.246362039 |
| 9-10AM Pre | Citrate/Creatinine Ratio | 0.441938 ratio | Standard Deviation 0.209042617 |
| First Void Pre | Citrate/Creatinine Ratio | 0.423415 ratio | Standard Deviation 0.22046721 |
| First Void Post | Citrate/Creatinine Ratio | 0.404892 ratio | Standard Deviation 0.248163828 |
Primary
pH
pH at 4 voids throughout the day. Pre = baseline fluid intake; Post
Time frame: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm)
Population: Each participant had urine collected at each time listed: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm). Data was collected on the Citrate/Creatinine Ratio at each time period void. Thus, at each time of day, there was an N equivalent to the number of voids across all entire 20 participant cohort. Since it was the same participant providing the void at the different times, the sum of participants does not add to the n in the study population (20).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5pm Void Post | pH | 6.52770 pH | Standard Deviation 0.479508661 |
| 5p.m. Pre | pH | 6.32645 pH | Standard Deviation 0.666506167 |
| 1-2 pm Post | pH | 6.34060 pH | Standard Deviation 0.621006253 |
| 1-2pm Void Pre | pH | 6.37845 pH | Standard Deviation 0.616991723 |
| 9-10AM Post | pH | 6.43430 pH | Standard Deviation 0.729245327 |
| 9-10AM Pre | pH | 6.24125 pH | Standard Deviation 0.70866872 |
| First Void Pre | pH | 6.08345 pH | Standard Deviation 0.47842631 |
| First Void Post | pH | 6.01865 pH | Standard Deviation 0.477511011 |
Primary
Specific Gravity (SG)
SG at 4 voids throughout the day. Pre = baseline fluid intake; Post
Time frame: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm)
Population: Each participant had urine collected at each time listed: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm). Data was collected on the Citrate/Creatinine Ratio at each time period void. Thus, at each time of day, there was an N equivalent to the number of voids across all entire 20 participant cohort. Since it was the same participant providing the void at the different times, the sum of participants does not add to the n in the study population (20).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5pm Void Post | Specific Gravity (SG) | 1.01725 g/mL | Standard Deviation 0.003851644 |
| 5p.m. Pre | Specific Gravity (SG) | 1.01525 g/mL | Standard Deviation 0.005773503 |
| 1-2 pm Post | Specific Gravity (SG) | 1.01725 g/mL | Standard Deviation 0.005799975 |
| 1-2pm Void Pre | Specific Gravity (SG) | 1.01850 g/mL | Standard Deviation 0.005745131 |
| 9-10AM Post | Specific Gravity (SG) | 1.01950 g/mL | Standard Deviation 0.003906066 |
| 9-10AM Pre | Specific Gravity (SG) | 1.02051 g/mL | Standard Deviation 0.005058298 |
| First Void Pre | Specific Gravity (SG) | 1.02000 g/mL | Standard Deviation 0.004552929 |
| First Void Post | Specific Gravity (SG) | 1.01825 g/mL | Standard Deviation 0.004537426 |
Primary
Total Fluid Intake
Time frame: Over 4 day study period
Population: Each participant completed the study, having their total fluid intake measured on each day. Thus, the overall number of participants does not add to the study total (n=20) as each participant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5pm Void Post | Total Fluid Intake | 2416.854 mL | Standard Deviation 1033 |
| 5p.m. Pre | Total Fluid Intake | 2625.093 mL | Standard Deviation 663.8 |
| 1-2 pm Post | Total Fluid Intake | 3116.562 mL | Standard Deviation 1308 |
| 1-2pm Void Pre | Total Fluid Intake | 3396.781 mL | Standard Deviation 1312 |