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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Renal Insufficiency, Chronic; Time Restricted Feeding
• Intervention / Treatment: Behavioral: Time-restricted feeding(TRF)

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangdong Provincial Hospital of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Control; The control group was asked to continue their usual low-protein diet eating schedule and pattern.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in eGFR (ml/min/1.73m2)	eGFR at final visit - eGFR at initial visit	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body weight (Kilograms)	body weight at final visit - body weight at initial visit	12 weeks
Changes in waist circumference (cm)	waist circumference at final visit - waist circumference at initial visit	12 weeks
Change in body mass index (kg/m2)	body mass index at final visit - body mass index at initial visit	12 weeks
Changes in serum total cholesterol levels (mmol/L)	serum total cholesterol levels at final visit - serum total cholesterol levels at initial visit	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	12 weeks
Changes in serum triglyceride levels (mmol/L)	serum triglyceride levels at final visit - serum triglyceride levels at initial visit	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	12 weeks
Changes in serum albumin (g/L)	serum albumin at final visit - serum albumin at initial visit	12 weeks
Changes in total serum protein (g/L)	total serum protein at final visit - total serum protein at initial visit	12 weeks
Changes in fat free mass (kg)	fat free mass at final visit - fat free mass at initial visit	12 weeks
Changes in body fat mass (kg)	body fat mass at final visit - body fat mass at initial visit	12 weeks
Changes in percent body fat (%)	percent body fat at final visit - percent body fat at initial visit	12 weeks
Changes in waist-hip ratio	waist-hip ratio at final visit - waist-hip ratio at initial visit	12 weeks
Changes in soft lean mass (kg)	soft lean mass at final visit - soft lean mass at initial visit	12 weeks
Changes in visceral fat area (cm2)	visceral fat area at final visit - visceral fat area at initial visit	12 weeks
Changes in arm circumference (cm)	arm circumference at final visit - arm circumference at initial visit	12 weeks
Changes in triceps skin fold thickness (cm)	triceps skin fold thickness at final visit - triceps skin fold thickness at initial visit	12 weeks
Changes in grip strength (kg)	grip strength at final visit - grip strength at initial visit	12 weeks
Changes in fasting blood glucose (mmol/L)	fasting blood glucose at final visit - fasting blood glucose at initial visit	12 weeks
Changes in serum creatinine (umol/L)	serum creatinine at final visit - serum creatinine at initial visit	12 weeks
Changes in blood urea nitrogen (mmol/L)	blood urea nitrogen at final visit - blood urea nitrogen at initial visit	12 weeks
Changes in serum uric acid (umol/L)	serum uric acid at final visit - serum uric acid at initial visit	12 weeks
Changes in proteinuria creatinine ratio (g/g)	proteinuria creatinine ratio at final visit - proteinuria creatinine ratio at initial visit	12 weeks
Changes in serum cystatin C (mg/L)	serum cystatin C at final visit - serum cystatin C at initial visit	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	12 weeks
Changes in interleukin-6 (pg/mL)	interleukin-6 at final visit - interleukin-6 at initial visit	12 weeks
Changes in tumor necrosis factor-α (pg/mL)	tumor necrosis factor-α at final visit - tumor necrosis factor-α at initial visit	12 weeks
Changes in C-reactive protein (mg/L)	C-reactive protein at final visit - C-reactive protein at initial visit	12 weeks
Changes in species of intestinal flora	species of intestinal flora at final visit - species of intestinal flora at initial visit	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in hunger scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Changes in fatigue scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Changes in satiety scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Changes in gastrointestinal flatulence scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Changes in nausea and vomiting scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Changes in constipation scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Changes in diarrhea scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Changes in dry mouth and bitterness scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Changes in dizziness and headache scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Changes in irritability scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Changes in anxiety scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Changes in depression scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12

Collaborators and Investigators

• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Investigators: Study Chair: Xu-sheng Liu, M.M, Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: obesity; chronic kidney disease; time-restricted feeding
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: YF2021-142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No