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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05037747
• Other study ID #: YF2021-142
• Status: Completed
• Phase: N/A
• Start date: August 12, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 1, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Time Restricted Feeding

Intervention

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.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in hunger scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Other	Changes in fatigue scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Other	Changes in satiety scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Other	Changes in gastrointestinal flatulence scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Other	Changes in nausea and vomiting scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Other	Changes in constipation scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Other	Changes in diarrhea scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Other	Changes in dry mouth and bitterness scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Other	Changes in dizziness and headache scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Other	Changes in irritability scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Other	Changes in anxiety scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Other	Changes in depression scores	Assessed using Visual Analog Scales (VAS with a scale of 1-10)	Weeks 6 and 12
Primary	Change in eGFR (ml/min/1.73m2)	eGFR at final visit - eGFR at initial visit	12 weeks
Secondary	Changes in body weight (Kilograms)	body weight at final visit - body weight at initial visit	12 weeks
Secondary	Changes in waist circumference (cm)	waist circumference at final visit - waist circumference at initial visit	12 weeks
Secondary	Change in body mass index (kg/m2)	body mass index at final visit - body mass index at initial visit	12 weeks
Secondary	Changes in serum total cholesterol levels (mmol/L)	serum total cholesterol levels at final visit - serum total cholesterol levels at initial visit	12 weeks
Secondary	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
Secondary	Changes in serum triglyceride levels (mmol/L)	serum triglyceride levels at final visit - serum triglyceride levels at initial visit	12 weeks
Secondary	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
Secondary	Changes in serum albumin (g/L)	serum albumin at final visit - serum albumin at initial visit	12 weeks
Secondary	Changes in total serum protein (g/L)	total serum protein at final visit - total serum protein at initial visit	12 weeks
Secondary	Changes in fat free mass (kg)	fat free mass at final visit - fat free mass at initial visit	12 weeks
Secondary	Changes in body fat mass (kg)	body fat mass at final visit - body fat mass at initial visit	12 weeks
Secondary	Changes in percent body fat (%)	percent body fat at final visit - percent body fat at initial visit	12 weeks
Secondary	Changes in waist-hip ratio	waist-hip ratio at final visit - waist-hip ratio at initial visit	12 weeks
Secondary	Changes in soft lean mass (kg)	soft lean mass at final visit - soft lean mass at initial visit	12 weeks
Secondary	Changes in visceral fat area (cm2)	visceral fat area at final visit - visceral fat area at initial visit	12 weeks
Secondary	Changes in arm circumference (cm)	arm circumference at final visit - arm circumference at initial visit	12 weeks
Secondary	Changes in triceps skin fold thickness (cm)	triceps skin fold thickness at final visit - triceps skin fold thickness at initial visit	12 weeks
Secondary	Changes in grip strength (kg)	grip strength at final visit - grip strength at initial visit	12 weeks
Secondary	Changes in fasting blood glucose (mmol/L)	fasting blood glucose at final visit - fasting blood glucose at initial visit	12 weeks
Secondary	Changes in serum creatinine (umol/L)	serum creatinine at final visit - serum creatinine at initial visit	12 weeks
Secondary	Changes in blood urea nitrogen (mmol/L)	blood urea nitrogen at final visit - blood urea nitrogen at initial visit	12 weeks
Secondary	Changes in serum uric acid (umol/L)	serum uric acid at final visit - serum uric acid at initial visit	12 weeks
Secondary	Changes in proteinuria creatinine ratio (g/g)	proteinuria creatinine ratio at final visit - proteinuria creatinine ratio at initial visit	12 weeks
Secondary	Changes in serum cystatin C (mg/L)	serum cystatin C at final visit - serum cystatin C at initial visit	12 weeks
Secondary	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
Secondary	Changes in interleukin-6 (pg/mL)	interleukin-6 at final visit - interleukin-6 at initial visit	12 weeks
Secondary	Changes in tumor necrosis factor-a (pg/mL)	tumor necrosis factor-a at final visit - tumor necrosis factor-a at initial visit	12 weeks
Secondary	Changes in C-reactive protein (mg/L)	C-reactive protein at final visit - C-reactive protein at initial visit	12 weeks
Secondary	Changes in species of intestinal flora	species of intestinal flora at final visit - species of intestinal flora at initial visit	12 weeks