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

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status: Completed

Conditions: Obesity; Time Restricted Feeding; Renal Insufficiency, Chronic

Treatments: Behavioral: Time-restricted feeding(TRF)

Study type: Interventional

Funder types: Other

Identifiers

NCT05037747

YF2021-142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Time-restricted feeding(TRF)

Experimental group

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.

Treatment:

Behavioral: Time-restricted feeding(TRF)

Control

No Intervention group

Description:

The control group was asked to continue their usual low-protein diet eating schedule and pattern.