Analysis of Urine Composition Saturation and Dietary Intervention in Subjects Without Urinary Calculi

NCT05102279 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-02-01

No results posted yet for this study

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.

Conditions

  • Calculi, Urinary
  • Dietary Supplements
  • Urine Specimen Collection

Interventions

DIETARY_SUPPLEMENT

Giving subjects different phosphorus diets at different stages of the trial

Ordinary phosphorus diet: Phosphorus content 1500mg High phosphorus diet: Phosphorus content 2500mg (inorganic phosphorus is added to the ordinary phosphorus diet) Low phosphorus diet: Phosphorus content 500mg (Protein content is achieved through chicken albumen and addition of low-phosphorus whey protein powder) The ratio of plant protein and animal protein is the same as the other two diets. In addition, calcium-magnesium tablets and potassium chloride salt are added to achieve the same calcium, magnesium and potassium content as the other two diets.) There are 2 recipes for each diet. Ensure 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 body weight 70kg) Protein: 110g Fat: 55-60g Carbohydrate: 300g Calcium: 600-700mg Magnesium: 350-400mg Sodium: 4600mg Potassium: 2500mg

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    lead OTHER

Principal Investigators

  • Feng Ding, PhD · Division of Nephrology,Shanghai Ninth People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-23
Primary Completion
2024-07-31
Completion
2024-12-30

Countries

  • China

Study Locations

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Read the full study record

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View NCT05102279 on ClinicalTrials.gov