Clinical trial NCT05037747: 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
Overall status: COMPLETED
Phase: NA
Conditions: Time Restricted Feeding
Renal Insufficiency, Chronic
Obesity
Keywords: time-restricted feeding
chronic kidney disease
obesity
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in eGFR (ml/min/1.73m2)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in body weight (Kilograms)
timeFrame: 12 weeks
measure: Changes in waist circumference (cm)
timeFrame: 12 weeks
measure: Change in body mass index (kg/m2)
timeFrame: 12 weeks
measure: Changes in serum total cholesterol levels (mmol/L)
timeFrame: 12 weeks
measure: Changes in serum low density lipoprotein cholesterol levels (mmol/L)
timeFrame: 12 weeks
measure: Changes in serum triglyceride levels (mmol/L)
timeFrame: 12 weeks
measure: Changes in serum high density lipoprotein cholesterol levels (mmol/L)
timeFrame: 12 weeks
measure: Changes in serum albumin (g/L)
timeFrame: 12 weeks
measure: Changes in total serum protein (g/L)
timeFrame: 12 weeks
measure: Changes in fat free mass (kg)
timeFrame: 12 weeks
measure: Changes in body fat mass (kg)
timeFrame: 12 weeks
measure: Changes in percent body fat (%)
timeFrame: 12 weeks
measure: Changes in waist-hip ratio
timeFrame: 12 weeks
measure: Changes in soft lean mass (kg)
timeFrame: 12 weeks
measure: Changes in visceral fat area (cm2)
timeFrame: 12 weeks
measure: Changes in arm circumference (cm)
timeFrame: 12 weeks
measure: Changes in triceps skin fold thickness (cm)
timeFrame: 12 weeks
measure: Changes in grip strength (kg)
timeFrame: 12 weeks
measure: Changes in fasting blood glucose (mmol/L)
timeFrame: 12 weeks
measure: Changes in serum creatinine (umol/L)
timeFrame: 12 weeks
measure: Changes in blood urea nitrogen (mmol/L)
timeFrame: 12 weeks
measure: Changes in serum uric acid (umol/L)
timeFrame: 12 weeks
measure: Changes in proteinuria creatinine ratio (g/g)
timeFrame: 12 weeks
measure: Changes in serum cystatin C (mg/L)
timeFrame: 12 weeks
measure: Changes in total urine urea in 24 hours (mmol/24h)
timeFrame: 12 weeks
measure: Changes in interleukin-6 (pg/mL)
timeFrame: 12 weeks
measure: Changes in tumor necrosis factor-α (pg/mL)
timeFrame: 12 weeks
measure: Changes in C-reactive protein (mg/L)
timeFrame: 12 weeks
measure: Changes in species of intestinal flora
timeFrame: 12 weeks
Other outcomes:
measure: Changes in hunger scores
timeFrame: Weeks 6 and 12
measure: Changes in fatigue scores
timeFrame: Weeks 6 and 12
measure: Changes in satiety scores
timeFrame: Weeks 6 and 12
measure: Changes in gastrointestinal flatulence scores
timeFrame: Weeks 6 and 12
measure: Changes in nausea and vomiting scores
timeFrame: Weeks 6 and 12
measure: Changes in constipation scores
timeFrame: Weeks 6 and 12
measure: Changes in diarrhea scores
timeFrame: Weeks 6 and 12
measure: Changes in dry mouth and bitterness scores
timeFrame: Weeks 6 and 12
measure: Changes in dizziness and headache scores
timeFrame: Weeks 6 and 12
measure: Changes in irritability scores
timeFrame: Weeks 6 and 12
measure: Changes in anxiety scores
timeFrame: Weeks 6 and 12
measure: Changes in depression scores
timeFrame: Weeks 6 and 12
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Xu-sheng Liu, M.M
role: STUDY_CHAIR
References: