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

July 2, 2022 updated by: Liu Xu-sheng, Guangdong Provincial Hospital of Traditional Chinese Medicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Provincial Hospital of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
No Intervention: Control
The control group was asked to continue their usual low-protein diet eating schedule and pattern.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in eGFR (ml/min/1.73m2)
Time Frame: 12 weeks
eGFR at final visit - eGFR at initial visit
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in body weight (Kilograms)
Time Frame: 12 weeks
body weight at final visit - body weight at initial visit
12 weeks
Changes in waist circumference (cm)
Time Frame: 12 weeks
waist circumference at final visit - waist circumference at initial visit
12 weeks
Change in body mass index (kg/m2)
Time Frame: 12 weeks
body mass index at final visit - body mass index at initial visit
12 weeks
Changes in serum total cholesterol levels (mmol/L)
Time Frame: 12 weeks
serum total cholesterol levels at final visit - serum total cholesterol levels at initial visit
12 weeks
Changes in serum low density lipoprotein cholesterol levels (mmol/L)
Time Frame: 12 weeks
serum low density lipoprotein cholesterol levels at final visit - serum low density lipoprotein cholesterol levels at initial visit
12 weeks
Changes in serum triglyceride levels (mmol/L)
Time Frame: 12 weeks
serum triglyceride levels at final visit - serum triglyceride levels at initial visit
12 weeks
Changes in serum high density lipoprotein cholesterol levels (mmol/L)
Time Frame: 12 weeks
serum high density lipoprotein cholesterol levels at final visit - serum high density lipoprotein cholesterol levels at initial visit
12 weeks
Changes in serum albumin (g/L)
Time Frame: 12 weeks
serum albumin at final visit - serum albumin at initial visit
12 weeks
Changes in total serum protein (g/L)
Time Frame: 12 weeks
total serum protein at final visit - total serum protein at initial visit
12 weeks
Changes in fat free mass (kg)
Time Frame: 12 weeks
fat free mass at final visit - fat free mass at initial visit
12 weeks
Changes in body fat mass (kg)
Time Frame: 12 weeks
body fat mass at final visit - body fat mass at initial visit
12 weeks
Changes in percent body fat (%)
Time Frame: 12 weeks
percent body fat at final visit - percent body fat at initial visit
12 weeks
Changes in waist-hip ratio
Time Frame: 12 weeks
waist-hip ratio at final visit - waist-hip ratio at initial visit
12 weeks
Changes in soft lean mass (kg)
Time Frame: 12 weeks
soft lean mass at final visit - soft lean mass at initial visit
12 weeks
Changes in visceral fat area (cm2)
Time Frame: 12 weeks
visceral fat area at final visit - visceral fat area at initial visit
12 weeks
Changes in arm circumference (cm)
Time Frame: 12 weeks
arm circumference at final visit - arm circumference at initial visit
12 weeks
Changes in triceps skin fold thickness (cm)
Time Frame: 12 weeks
triceps skin fold thickness at final visit - triceps skin fold thickness at initial visit
12 weeks
Changes in grip strength (kg)
Time Frame: 12 weeks
grip strength at final visit - grip strength at initial visit
12 weeks
Changes in fasting blood glucose (mmol/L)
Time Frame: 12 weeks
fasting blood glucose at final visit - fasting blood glucose at initial visit
12 weeks
Changes in serum creatinine (umol/L)
Time Frame: 12 weeks
serum creatinine at final visit - serum creatinine at initial visit
12 weeks
Changes in blood urea nitrogen (mmol/L)
Time Frame: 12 weeks
blood urea nitrogen at final visit - blood urea nitrogen at initial visit
12 weeks
Changes in serum uric acid (umol/L)
Time Frame: 12 weeks
serum uric acid at final visit - serum uric acid at initial visit
12 weeks
Changes in proteinuria creatinine ratio (g/g)
Time Frame: 12 weeks
proteinuria creatinine ratio at final visit - proteinuria creatinine ratio at initial visit
12 weeks
Changes in serum cystatin C (mg/L)
Time Frame: 12 weeks
serum cystatin C at final visit - serum cystatin C at initial visit
12 weeks
Changes in total urine urea in 24 hours (mmol/24h)
Time Frame: 12 weeks
total urine urea in 24 hours at final visit - total urine urea in 24 hours at initial visit
12 weeks
Changes in interleukin-6 (pg/mL)
Time Frame: 12 weeks
interleukin-6 at final visit - interleukin-6 at initial visit
12 weeks
Changes in tumor necrosis factor-α (pg/mL)
Time Frame: 12 weeks
tumor necrosis factor-α at final visit - tumor necrosis factor-α at initial visit
12 weeks
Changes in C-reactive protein (mg/L)
Time Frame: 12 weeks
C-reactive protein at final visit - C-reactive protein at initial visit
12 weeks
Changes in species of intestinal flora
Time Frame: 12 weeks
species of intestinal flora at final visit - species of intestinal flora at initial visit
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in hunger scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12
Changes in fatigue scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12
Changes in satiety scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12
Changes in gastrointestinal flatulence scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12
Changes in nausea and vomiting scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12
Changes in constipation scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12
Changes in diarrhea scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12
Changes in dry mouth and bitterness scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12
Changes in dizziness and headache scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12
Changes in irritability scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12
Changes in anxiety scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12
Changes in depression scores
Time Frame: Weeks 6 and 12
Assessed using Visual Analog Scales (VAS with a scale of 1-10)
Weeks 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Xu-sheng Liu, M.M, Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YF2021-142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings