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

NCT ID: NCT05037747

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-12
• Study Completion Date: 2022-07-01

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.

Conditions

Time Restricted Feeding; Renal Insufficiency, Chronic; Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Time-restricted feeding(TRF)

Intervention Type: BEHAVIORAL

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Liu Xu-sheng

Head of Nephrology, Director, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xu-sheng Liu, M.M

Role: STUDY_CHAIR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

YF2021-142

Identifier Type: -

Identifier Source: org_study_id