Clinical trial NCT05102279: Analysis of Urine Composition Saturation and Dietary Intervention in Subjects Without Urinary Calculi
Official title: Analysis of Urine Composition Saturation and Dietary Intervention in Subjects Without Urinary Calculi
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Calculi, Urinary
Dietary Supplements
Urine Specimen Collection
Keywords: Dietary Supplements
Urine Saturation factor
Calculi, Urinary
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants were randomly divided into two groups.A group of participants first received a normal phosphorus diet for 2 days, followed by a low-phosphorus diet for 3 days, then a normal phosphorus diet for 2 days, and a high-phosphorus diet for 3 days.The other group of participants first received a normal phosphorus diet for 2 days, followed by a high phosphorus diet for 3 days, then a normal phosphorus diet for 2 days, and a low phosphorus diet for 3 days.
Primary purpose: PREVENTION

Brief summary: Urinary calculi have become a global public health problem, which brings a huge economic burden to society and individuals. The pathogenesis of urinary calculi is not completely clear. Supersaturation of urinary components is a necessary condition for the formation of urinary calculi. The causes of stone formation are closely related to diet, drugs, metabolic disorders, basic diseases, genetic factors, environment and so on. Diet essentially determines the composition of urine, which affects the formation of urinary calculi. The effect of dietary phosphorus intake on stones is not clear. There is a lack of data to support dietary phosphorus as an influencing factor of stone formation. Phosphorus is present in most foods. 24h urine composition analysis is of great value in predicting the occurrence and composition of urinary calculi. However, due to the interaction between urine components, a single urine component can not well predict the occurrence of stones. Therefore, the researchers introduced the relative supersaturation of common stone components in urine to predict the incidence of stones. Therefore, we want to give healthy adults a diet with different phosphorus content for a period of time to clarify the effect of phosphorus in the diet on 24h urine composition level and urine relative supersaturation, so as to further explore the relationship between dietary phosphorus and the incidence of urinary calculi. To provide more clear recommendations for early prevention of urinary calculi, and provide more evidence for clinical decision-making, thereby reducing the incidence rate of urinary calculi.

Detailed description: \*Diet: Ordinary phosphorus diet: phosphorus content 1500mg High-phosphorus diet: Phosphorus content is 2500mg (inorganic phosphorus is added to the ordinary phosphorus diet) Low-phosphorus diet: Phosphorus content 500mg (The protein content and the ratio of plant protein and animal protein are consistent with the other two diets by adding egg protein and adding low-phosphorus whey protein powder. In addition, calcium magnesium tablets and potassium chloride salt are added to achieve the same calcium, magnesium and potassium content as others. The two diets are consistent)

There are 2 recipes for each diet, and each recipe guarantees that the energy, protein, fat, carbohydrate, calcium, magnesium, sodium, potassium, oxalic acid content, vegetable protein and animal protein ratio are basically the same:

Energy: 2100kcal (30kcal/kg, standard weight 70kg);Protein: 110g;Fat: 55-60g;Carbohydrate: 300g;Calcium: 600-700mg;Magnesium: 350-400mg;Sodium: 4600mg;Potassium: 2500mg Water:Giving subjects 2L of purified water without any minerals every day

* Specimen We will collect 24h urine and feces for the whole day on the 2nd, 5th, 7th, and 10th days of the experiment, and collected morning blood and random urine on the 3rd, 6th, 8th, and 11th days.
* Analysis We will use Equil 2 software to calculate the relative supersaturation of urine, and use SPSS software to analysis data

Eligibility criteria: Inclusion Criteria:

* Age: 20-45 years old
* 18. 5≤Body Mass Index≤ 23. 9
* Normal oral diet

Exclusion Criteria:

* People who have had or are suffering from urinary tract stones , or have the following diseases leading to the formation of stones: renal tubular acidosis, gout, hyperuricemia, chronic diarrhea, insulin resistance, hyperparathyroidism, idiopathic hypercalcemia, hypertension, diabetes mellitus
* CKD-EPI-eGFR\<90ml/min1.73m-2)
* The following drugs are being used: cathartic, aspirin, angiotensin converting enzyme inhibitor，angiotensin II receptor antagonist，diuretic, acid inhibitor, alkali or carbonic anhydrase inhibitor, phosphorus binder, calcium agent and active vitamin D;
* Previous gastrointestinal diseases or gastrointestinal surgery
* Application of enteral and parenteral nutrition
* Complicated with infection, with or without antibiotic treatment
* Mental patients or unable to cooperate for various reasons

Primary outcomes:
measure: Subjects complete the trial within 10 days
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Division of Nephrology,Shanghai Ninth People's Hospital
name: Feng Ding, PhD
role: STUDY_DIRECTOR
References:
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citation: Shadman A, Bastani B. Kidney Calculi: Pathophysiology and as a Systemic Disorder. Iran J Kidney Dis. 2017 May;11(3):180-191.
citation: Prezioso D, Strazzullo P, Lotti T, Bianchi G, Borghi L, Caione P, Carini M, Caudarella R, Ferraro M, Gambaro G, Gelosa M, Guttilla A, Illiano E, Martino M, Meschi T, Messa P, Miano R, Napodano G, Nouvenne A, Rendina D, Rocco F, Rosa M, Sanseverino R, Salerno A, Spatafora S, Tasca A, Ticinesi A, Travaglini F, Trinchieri A, Vespasiani G, Zattoni F; CLU Working Group. Dietary treatment of urinary risk factors for renal stone formation. A review of CLU Working Group. Arch Ital Urol Androl. 2015 Jul 7;87(2):105-20. doi: 10.4081/aiua.2015.2.105.
citation: Peacock M. Phosphate Metabolism in Health and Disease. Calcif Tissue Int. 2021 Jan;108(1):3-15. doi: 10.1007/s00223-020-00686-3. Epub 2020 Apr 7.