Back to resultsEffects of TRF on Obese Patients With CKD Stage 3-4
Primary Purpose
Time Restricted Feeding, Renal Insufficiency, Chronic, Obesity
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Time-restricted feeding(TRF)
Sponsored by
About this trial
This is an interventional prevention trial for Time Restricted Feeding focused on measuring time-restricted feeding, chronic kidney disease, obesity
Eligibility Criteria
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
Sites / Locations
- Guangdong Provincial Hospital of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Time-restricted feeding(TRF)
Control
Arm Description
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.
The control group was asked to continue their usual low-protein diet eating schedule and pattern.
Outcomes
Primary Outcome Measures
Change in eGFR (ml/min/1.73m2)
eGFR at final visit - eGFR at initial visit
Secondary Outcome Measures
Changes in body weight (Kilograms)
body weight at final visit - body weight at initial visit
Changes in waist circumference (cm)
waist circumference at final visit - waist circumference at initial visit
Change in body mass index (kg/m2)
body mass index at final visit - body mass index at initial visit
Changes in serum total cholesterol levels (mmol/L)
serum total cholesterol levels at final visit - serum total cholesterol levels at initial visit
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
Changes in serum triglyceride levels (mmol/L)
serum triglyceride levels at final visit - serum triglyceride levels at initial visit
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
Changes in serum albumin (g/L)
serum albumin at final visit - serum albumin at initial visit
Changes in total serum protein (g/L)
total serum protein at final visit - total serum protein at initial visit
Changes in fat free mass (kg)
fat free mass at final visit - fat free mass at initial visit
Changes in body fat mass (kg)
body fat mass at final visit - body fat mass at initial visit
Changes in percent body fat (%)
percent body fat at final visit - percent body fat at initial visit
Changes in waist-hip ratio
waist-hip ratio at final visit - waist-hip ratio at initial visit
Changes in soft lean mass (kg)
soft lean mass at final visit - soft lean mass at initial visit
Changes in visceral fat area (cm2)
visceral fat area at final visit - visceral fat area at initial visit
Changes in arm circumference (cm)
arm circumference at final visit - arm circumference at initial visit
Changes in triceps skin fold thickness (cm)
triceps skin fold thickness at final visit - triceps skin fold thickness at initial visit
Changes in grip strength (kg)
grip strength at final visit - grip strength at initial visit
Changes in fasting blood glucose (mmol/L)
fasting blood glucose at final visit - fasting blood glucose at initial visit
Changes in serum creatinine (umol/L)
serum creatinine at final visit - serum creatinine at initial visit
Changes in blood urea nitrogen (mmol/L)
blood urea nitrogen at final visit - blood urea nitrogen at initial visit
Changes in serum uric acid (umol/L)
serum uric acid at final visit - serum uric acid at initial visit
Changes in proteinuria creatinine ratio (g/g)
proteinuria creatinine ratio at final visit - proteinuria creatinine ratio at initial visit
Changes in serum cystatin C (mg/L)
serum cystatin C at final visit - serum cystatin C at initial visit
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
Changes in interleukin-6 (pg/mL)
interleukin-6 at final visit - interleukin-6 at initial visit
Changes in tumor necrosis factor-α (pg/mL)
tumor necrosis factor-α at final visit - tumor necrosis factor-α at initial visit
Changes in C-reactive protein (mg/L)
C-reactive protein at final visit - C-reactive protein at initial visit
Changes in species of intestinal flora
species of intestinal flora at final visit - species of intestinal flora at initial visit
Full Information
NCT ID
NCT05037747
First Posted
August 31, 2021
Last Updated
July 2, 2022
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05037747
Brief Title
Effects of TRF on Obese Patients With CKD Stage 3-4
Official Title
Effects of Time-restricted Feeding on Obese Patients With Chronic Kidney Disease Stage 3-4: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Time Restricted Feeding, Renal Insufficiency, Chronic, Obesity
Keywords
time-restricted feeding, chronic kidney disease, obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It was non-randomized trial study design, two parallel groups were assigned to time-restricted feeding(TRF) and control group and to do the intervention for 12 weeks.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Time-restricted feeding(TRF)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group was asked to continue their usual low-protein diet eating schedule and pattern.
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted feeding(TRF)
Intervention Description
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 Measure Information:
Title
Change in eGFR (ml/min/1.73m2)
Description
eGFR at final visit - eGFR at initial visit
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in body weight (Kilograms)
Description
body weight at final visit - body weight at initial visit
Time Frame
12 weeks
Title
Changes in waist circumference (cm)
Description
waist circumference at final visit - waist circumference at initial visit
Time Frame
12 weeks
Title
Change in body mass index (kg/m2)
Description
body mass index at final visit - body mass index at initial visit
Time Frame
12 weeks
Title
Changes in serum total cholesterol levels (mmol/L)
Description
serum total cholesterol levels at final visit - serum total cholesterol levels at initial visit
Time Frame
12 weeks
Title
Changes in serum low density lipoprotein cholesterol levels (mmol/L)
Description
serum low density lipoprotein cholesterol levels at final visit - serum low density lipoprotein cholesterol levels at initial visit
Time Frame
12 weeks
Title
Changes in serum triglyceride levels (mmol/L)
Description
serum triglyceride levels at final visit - serum triglyceride levels at initial visit
Time Frame
12 weeks
Title
Changes in serum high density lipoprotein cholesterol levels (mmol/L)
Description
serum high density lipoprotein cholesterol levels at final visit - serum high density lipoprotein cholesterol levels at initial visit
Time Frame
12 weeks
Title
Changes in serum albumin (g/L)
Description
serum albumin at final visit - serum albumin at initial visit
Time Frame
12 weeks
Title
Changes in total serum protein (g/L)
Description
total serum protein at final visit - total serum protein at initial visit
Time Frame
12 weeks
Title
Changes in fat free mass (kg)
Description
fat free mass at final visit - fat free mass at initial visit
Time Frame
12 weeks
Title
Changes in body fat mass (kg)
Description
body fat mass at final visit - body fat mass at initial visit
Time Frame
12 weeks
Title
Changes in percent body fat (%)
Description
percent body fat at final visit - percent body fat at initial visit
Time Frame
12 weeks
Title
Changes in waist-hip ratio
Description
waist-hip ratio at final visit - waist-hip ratio at initial visit
Time Frame
12 weeks
Title
Changes in soft lean mass (kg)
Description
soft lean mass at final visit - soft lean mass at initial visit
Time Frame
12 weeks
Title
Changes in visceral fat area (cm2)
Description
visceral fat area at final visit - visceral fat area at initial visit
Time Frame
12 weeks
Title
Changes in arm circumference (cm)
Description
arm circumference at final visit - arm circumference at initial visit
Time Frame
12 weeks
Title
Changes in triceps skin fold thickness (cm)
Description
triceps skin fold thickness at final visit - triceps skin fold thickness at initial visit
Time Frame
12 weeks
Title
Changes in grip strength (kg)
Description
grip strength at final visit - grip strength at initial visit
Time Frame
12 weeks
Title
Changes in fasting blood glucose (mmol/L)
Description
fasting blood glucose at final visit - fasting blood glucose at initial visit
Time Frame
12 weeks
Title
Changes in serum creatinine (umol/L)
Description
serum creatinine at final visit - serum creatinine at initial visit
Time Frame
12 weeks
Title
Changes in blood urea nitrogen (mmol/L)
Description
blood urea nitrogen at final visit - blood urea nitrogen at initial visit
Time Frame
12 weeks
Title
Changes in serum uric acid (umol/L)
Description
serum uric acid at final visit - serum uric acid at initial visit
Time Frame
12 weeks
Title
Changes in proteinuria creatinine ratio (g/g)
Description
proteinuria creatinine ratio at final visit - proteinuria creatinine ratio at initial visit
Time Frame
12 weeks
Title
Changes in serum cystatin C (mg/L)
Description
serum cystatin C at final visit - serum cystatin C at initial visit
Time Frame
12 weeks
Title
Changes in total urine urea in 24 hours (mmol/24h)
Description
total urine urea in 24 hours at final visit - total urine urea in 24 hours at initial visit
Time Frame
12 weeks
Title
Changes in interleukin-6 (pg/mL)
Description
interleukin-6 at final visit - interleukin-6 at initial visit
Time Frame
12 weeks
Title
Changes in tumor necrosis factor-α (pg/mL)
Description
tumor necrosis factor-α at final visit - tumor necrosis factor-α at initial visit
Time Frame
12 weeks
Title
Changes in C-reactive protein (mg/L)
Description
C-reactive protein at final visit - C-reactive protein at initial visit
Time Frame
12 weeks
Title
Changes in species of intestinal flora
Description
species of intestinal flora at final visit - species of intestinal flora at initial visit
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Changes in hunger scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
Title
Changes in fatigue scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
Title
Changes in satiety scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
Title
Changes in gastrointestinal flatulence scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
Title
Changes in nausea and vomiting scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
Title
Changes in constipation scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
Title
Changes in diarrhea scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
Title
Changes in dry mouth and bitterness scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
Title
Changes in dizziness and headache scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
Title
Changes in irritability scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
Title
Changes in anxiety scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
Title
Changes in depression scores
Description
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Time Frame
Weeks 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu-sheng Liu, M.M
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of TRF on Obese Patients With CKD Stage 3-4
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