Effects of TRF on Obese Patients With CKD Stage 3-4
- Conditions
- ObesityRenal Insufficiency, ChronicTime Restricted Feeding
- Interventions
- Behavioral: Time-restricted feeding(TRF)
- Registration Number
- NCT05037747
- Lead Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Time-restricted feeding(TRF) Time-restricted feeding(TRF) 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 Outcome Measures
Name Time Method Change in eGFR (ml/min/1.73m2) 12 weeks eGFR at final visit - eGFR at initial visit
- Secondary Outcome Measures
Name Time Method Changes in serum low density lipoprotein cholesterol levels (mmol/L) 12 weeks serum low density lipoprotein cholesterol levels at final visit - serum low density lipoprotein cholesterol levels at initial visit
Changes in serum high density lipoprotein cholesterol levels (mmol/L) 12 weeks serum high density lipoprotein cholesterol levels at final visit - serum high density lipoprotein cholesterol levels at initial visit
Change in body mass index (kg/m2) 12 weeks body mass index at final visit - body mass index at initial visit
Changes in serum albumin (g/L) 12 weeks serum albumin at final visit - serum albumin at initial visit
Changes in body weight (Kilograms) 12 weeks body weight at final visit - body weight at initial visit
Changes in serum total cholesterol levels (mmol/L) 12 weeks serum total cholesterol levels at final visit - serum total cholesterol levels at initial visit
Changes in serum triglyceride levels (mmol/L) 12 weeks serum triglyceride levels at final visit - serum triglyceride levels at initial visit
Changes in soft lean mass (kg) 12 weeks soft lean mass at final visit - soft lean mass at initial visit
Changes in total serum protein (g/L) 12 weeks total serum protein at final visit - total serum protein at initial visit
Changes in proteinuria creatinine ratio (g/g) 12 weeks proteinuria creatinine ratio at final visit - proteinuria creatinine ratio at initial visit
Changes in total urine urea in 24 hours (mmol/24h) 12 weeks total urine urea in 24 hours at final visit - total urine urea in 24 hours at initial visit
Changes in tumor necrosis factor-α (pg/mL) 12 weeks tumor necrosis factor-α at final visit - tumor necrosis factor-α at initial visit
Changes in species of intestinal flora 12 weeks species of intestinal flora at final visit - species of intestinal flora at initial visit
Changes in waist circumference (cm) 12 weeks waist circumference at final visit - waist circumference at initial visit
Changes in fasting blood glucose (mmol/L) 12 weeks fasting blood glucose at final visit - fasting blood glucose at initial visit
Changes in interleukin-6 (pg/mL) 12 weeks interleukin-6 at final visit - interleukin-6 at initial visit
Changes in fat free mass (kg) 12 weeks fat free mass at final visit - fat free mass at initial visit
Changes in body fat mass (kg) 12 weeks body fat mass at final visit - body fat mass at initial visit
Changes in percent body fat (%) 12 weeks percent body fat at final visit - percent body fat at initial visit
Changes in arm circumference (cm) 12 weeks arm circumference at final visit - arm circumference at initial visit
Changes in grip strength (kg) 12 weeks grip strength at final visit - grip strength at initial visit
Changes in serum uric acid (umol/L) 12 weeks serum uric acid at final visit - serum uric acid at initial visit
Changes in serum cystatin C (mg/L) 12 weeks serum cystatin C at final visit - serum cystatin C at initial visit
Changes in waist-hip ratio 12 weeks waist-hip ratio at final visit - waist-hip ratio at initial visit
Changes in visceral fat area (cm2) 12 weeks visceral fat area at final visit - visceral fat area at initial visit
Changes in triceps skin fold thickness (cm) 12 weeks triceps skin fold thickness at final visit - triceps skin fold thickness at initial visit
Changes in serum creatinine (umol/L) 12 weeks serum creatinine at final visit - serum creatinine at initial visit
Changes in blood urea nitrogen (mmol/L) 12 weeks blood urea nitrogen at final visit - blood urea nitrogen at initial visit
Changes in C-reactive protein (mg/L) 12 weeks C-reactive protein at final visit - C-reactive protein at initial visit
Trial Locations
- Locations (1)
Guangdong Provincial Hospital of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China