An interventional study of Time-restricted feeding(TRF) in Time Restricted Feeding, Renal Insufficiency, Chronic and Obesity, sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-07.
Sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Prevention
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.
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 28 is below the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Guangdong Provincial Hospital of Traditional Chinese Medicine is the lead sponsor of 40 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Time-restricted feeding(TRF)
The control group was asked to continue their usual low-protein diet eating schedule and pattern.
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.
Change in eGFR (ml/min/1.73m2)
eGFR at final visit - eGFR at initial visit
Time frame: 12 weeks
Changes in body weight (Kilograms)
body weight at final visit - body weight at initial visit
Time frame: 12 weeks
Changes in waist circumference (cm)
waist circumference at final visit - waist circumference at initial visit
Time frame: 12 weeks
Change in body mass index (kg/m2)
body mass index at final visit - body mass index at initial visit
Time frame: 12 weeks
Changes in serum total cholesterol levels (mmol/L)
serum total cholesterol levels at final visit - serum total cholesterol levels at initial visit
Time frame: 12 weeks
Changes in serum low density lipoprotein cholesterol levels (mmol/L)
serum low density lipoprotein cholesterol levels at final visit - serum low density lipoprotein cholesterol levels at initial visit
Time frame: 12 weeks
Changes in serum triglyceride levels (mmol/L)
serum triglyceride levels at final visit - serum triglyceride levels at initial visit
Time frame: 12 weeks
Changes in serum high density lipoprotein cholesterol levels (mmol/L)
serum high density lipoprotein cholesterol levels at final visit - serum high density lipoprotein cholesterol levels at initial visit
Time frame: 12 weeks
Changes in serum albumin (g/L)
serum albumin at final visit - serum albumin at initial visit
Time frame: 12 weeks
Changes in total serum protein (g/L)
total serum protein at final visit - total serum protein at initial visit
Time frame: 12 weeks
Changes in fat free mass (kg)
fat free mass at final visit - fat free mass at initial visit
Time frame: 12 weeks
Changes in body fat mass (kg)
body fat mass at final visit - body fat mass at initial visit
Time frame: 12 weeks
Changes in percent body fat (%)
percent body fat at final visit - percent body fat at initial visit
Time frame: 12 weeks
Changes in waist-hip ratio
waist-hip ratio at final visit - waist-hip ratio at initial visit
Time frame: 12 weeks
Changes in soft lean mass (kg)
soft lean mass at final visit - soft lean mass at initial visit
Time frame: 12 weeks
Changes in visceral fat area (cm2)
visceral fat area at final visit - visceral fat area at initial visit
Time frame: 12 weeks
Changes in arm circumference (cm)
arm circumference at final visit - arm circumference at initial visit
Time frame: 12 weeks
Changes in triceps skin fold thickness (cm)
triceps skin fold thickness at final visit - triceps skin fold thickness at initial visit
Time frame: 12 weeks
Changes in grip strength (kg)
grip strength at final visit - grip strength at initial visit
Time frame: 12 weeks
Changes in fasting blood glucose (mmol/L)
fasting blood glucose at final visit - fasting blood glucose at initial visit
Time frame: 12 weeks
Changes in serum creatinine (umol/L)
serum creatinine at final visit - serum creatinine at initial visit
Time frame: 12 weeks
Changes in blood urea nitrogen (mmol/L)
blood urea nitrogen at final visit - blood urea nitrogen at initial visit
Time frame: 12 weeks
Changes in serum uric acid (umol/L)
serum uric acid at final visit - serum uric acid at initial visit
Time frame: 12 weeks
Changes in proteinuria creatinine ratio (g/g)
proteinuria creatinine ratio at final visit - proteinuria creatinine ratio at initial visit
Time frame: 12 weeks
Changes in serum cystatin C (mg/L)
serum cystatin C at final visit - serum cystatin C at initial visit
Time frame: 12 weeks
Changes in total urine urea in 24 hours (mmol/24h)
total urine urea in 24 hours at final visit - total urine urea in 24 hours at initial visit
Time frame: 12 weeks
Changes in interleukin-6 (pg/mL)
interleukin-6 at final visit - interleukin-6 at initial visit
Time frame: 12 weeks
Changes in tumor necrosis factor-α (pg/mL)
tumor necrosis factor-α at final visit - tumor necrosis factor-α at initial visit
Time frame: 12 weeks
Changes in C-reactive protein (mg/L)
C-reactive protein at final visit - C-reactive protein at initial visit
Time frame: 12 weeks
Changes in species of intestinal flora
species of intestinal flora at final visit - species of intestinal flora at initial visit
Time frame: 12 weeks
Changes in hunger scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Changes in fatigue scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Changes in satiety scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Changes in gastrointestinal flatulence scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Changes in nausea and vomiting scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Changes in constipation scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Changes in diarrhea scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Changes in dry mouth and bitterness scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Changes in dizziness and headache scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Changes in irritability scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Changes in anxiety scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Changes in depression scores
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time frame: Weeks 6 and 12
Plan to share: No
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Guangdong Provincial Hospital of Traditional Chinese Medicine