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Completed

NCT Number: NCT05037747

Effects of TRF on Obese Patients With CKD Stage 3-4

Obesity is associated with glomerular hyperfiltration leading to renal impairment and is a risk factor for the progression of kidney disease.Weight loss can reduce proteinuria and improve eGFR.Intermittent fasting is safe and effective, and in addition to improving body shape and weight in obese patients, it can also improve glucolipid metabolism, reduce proteinuria, improve kidney function and delay the progression of kidney disease.

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Key information

Conditions

Time Restricted Feeding Behavior Body Weight Chronic Disease Disease Attributes Fasting Feeding Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intermittent Fasting Kidney Diseases Male Urogenital Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

About this study

KDOQI clinical practice guideline for nutrition in chronic kidney disease (CKD) uses a low-protein diet to reduce renal impairment and delay progression. The current research hotspot is dietary intervention. Time-restricted feeding was used to intervene in the progression of CKD. It restrict the time of eating but not the eaten calories, which have a higher compliance and safety. Studies have shown that intermittent fasting in obese patients with CKD is not only reduce body weight, but also improves glycolipid metabolism, reduces proteinuria and delays the progression of kidney disease. Intermittent fasting is currently a scientific research hotspot, and there are few international studies on the implementation of intermittent fasting to delay the deterioration of renal function in obese CKD patients, and lack of data on Chinese patients, which has great research potential. Based on the above background, this study was conducted as an pilot clinical trial to explore the effects of intermittent fasting on obese patients with CKD and to observe its effectiveness, safety and compliance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years
  • CKD stage 3-4 and not on dialysis (eGFR: 15-59ml/min/1.73m2)
  • BMI ≥ 25 kg/m2
  • Good reading and comprehension skills, simple smartphone operation and no communication difficulties
  • Signed informed consent

Exclusion criteria

  • Pregnant and breastfeeding
  • End-stage diseases
  • Acute and active diseases such as gastrointestinal bleeding or acute infections, serious decompensation with diseases such as cirrhosis decompensation stage, malignant tumor, serious heart and lung diseases, severe primary diseases of hematopoietic system, severe hypertension (systolic blood pressure ≥200mmHg, diastolic blood pressure ≥120mmHg) and difficult to control blood pressure, within 3 months after major surgery, such as open surgery
  • Mental patients
  • Using medium-high doses of hormones and immunosuppressants
  • Participating in other researchers
  • Taking other dietary therapies, undergoing weight loss treatment
  • Vegetarian
  • Type 1 diabetes and type 2 diabetes using insulin

Treatment and study plan

Time-restricted feeding(TRF)

Behavioral

The TRF group was asked to restrict the eating window to 8 hours a day, during waking hours and also continue a low-protein diet.

Primary outcomes

  1. Change in eGFR (ml/min/1.73m2)

    Time frame: 12 weeks

    eGFR at final visit - eGFR at initial visit

Secondary outcomes

  1. Changes in body weight (Kilograms)

    Time frame: 12 weeks

    body weight at final visit - body weight at initial visit

  2. Changes in waist circumference (cm)

    Time frame: 12 weeks

    waist circumference at final visit - waist circumference at initial visit

  3. Change in body mass index (kg/m2)

    Time frame: 12 weeks

    body mass index at final visit - body mass index at initial visit

  4. Changes in serum total cholesterol levels (mmol/L)

    Time frame: 12 weeks

    serum total cholesterol levels at final visit - serum total cholesterol levels at initial visit

  5. Changes in serum low density lipoprotein cholesterol levels (mmol/L)

    Time frame: 12 weeks

    serum low density lipoprotein cholesterol levels at final visit - serum low density lipoprotein cholesterol levels at initial visit

  6. Changes in serum triglyceride levels (mmol/L)

    Time frame: 12 weeks

    serum triglyceride levels at final visit - serum triglyceride levels at initial visit

  7. Changes in serum high density lipoprotein cholesterol levels (mmol/L)

    Time frame: 12 weeks

    serum high density lipoprotein cholesterol levels at final visit - serum high density lipoprotein cholesterol levels at initial visit

  8. Changes in serum albumin (g/L)

    Time frame: 12 weeks

    serum albumin at final visit - serum albumin at initial visit

  9. Changes in total serum protein (g/L)

    Time frame: 12 weeks

    total serum protein at final visit - total serum protein at initial visit

  10. Changes in fat free mass (kg)

    Time frame: 12 weeks

    fat free mass at final visit - fat free mass at initial visit

  11. Changes in body fat mass (kg)

    Time frame: 12 weeks

    body fat mass at final visit - body fat mass at initial visit

  12. Changes in percent body fat (%)

    Time frame: 12 weeks

    percent body fat at final visit - percent body fat at initial visit

  13. Changes in waist-hip ratio

    Time frame: 12 weeks

    waist-hip ratio at final visit - waist-hip ratio at initial visit

  14. Changes in soft lean mass (kg)

    Time frame: 12 weeks

    soft lean mass at final visit - soft lean mass at initial visit

  15. Changes in visceral fat area (cm2)

    Time frame: 12 weeks

    visceral fat area at final visit - visceral fat area at initial visit

  16. Changes in arm circumference (cm)

    Time frame: 12 weeks

    arm circumference at final visit - arm circumference at initial visit

  17. Changes in triceps skin fold thickness (cm)

    Time frame: 12 weeks

    triceps skin fold thickness at final visit - triceps skin fold thickness at initial visit

  18. Changes in grip strength (kg)

    Time frame: 12 weeks

    grip strength at final visit - grip strength at initial visit

  19. Changes in fasting blood glucose (mmol/L)

    Time frame: 12 weeks

    fasting blood glucose at final visit - fasting blood glucose at initial visit

  20. Changes in serum creatinine (umol/L)

    Time frame: 12 weeks

    serum creatinine at final visit - serum creatinine at initial visit

  21. Changes in blood urea nitrogen (mmol/L)

    Time frame: 12 weeks

    blood urea nitrogen at final visit - blood urea nitrogen at initial visit

  22. Changes in serum uric acid (umol/L)

    Time frame: 12 weeks

    serum uric acid at final visit - serum uric acid at initial visit

  23. Changes in proteinuria creatinine ratio (g/g)

    Time frame: 12 weeks

    proteinuria creatinine ratio at final visit - proteinuria creatinine ratio at initial visit

  24. Changes in serum cystatin C (mg/L)

    Time frame: 12 weeks

    serum cystatin C at final visit - serum cystatin C at initial visit

  25. Changes in total urine urea in 24 hours (mmol/24h)

    Time frame: 12 weeks

    total urine urea in 24 hours at final visit - total urine urea in 24 hours at initial visit

  26. Changes in interleukin-6 (pg/mL)

    Time frame: 12 weeks

    interleukin-6 at final visit - interleukin-6 at initial visit

  27. Changes in tumor necrosis factor-α (pg/mL)

    Time frame: 12 weeks

    tumor necrosis factor-α at final visit - tumor necrosis factor-α at initial visit

  28. Changes in C-reactive protein (mg/L)

    Time frame: 12 weeks

    C-reactive protein at final visit - C-reactive protein at initial visit

  29. Changes in species of intestinal flora

    Time frame: 12 weeks

    species of intestinal flora at final visit - species of intestinal flora at initial visit

Other outcomes

  1. Changes in hunger scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

  2. Changes in fatigue scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

  3. Changes in satiety scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

  4. Changes in gastrointestinal flatulence scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

  5. Changes in nausea and vomiting scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

  6. Changes in constipation scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

  7. Changes in diarrhea scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

  8. Changes in dry mouth and bitterness scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

  9. Changes in dizziness and headache scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

  10. Changes in irritability scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

  11. Changes in anxiety scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

  12. Changes in depression scores

    Time frame: Weeks 6 and 12

    Assessed using Visual Analog Scales (VAS with a scale of 1-10)

Sponsors and collaborators

Lead sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Other

Registry information

Official study title

Effects of Time-restricted Feeding on Obese Patients With Chronic Kidney Disease Stage 3-4: a Pilot Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 8, 2021
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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