Time Restricted FeedingNCT05037747

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

A study testing Time-restricted feeding(TRF) in people with Time Restricted Feeding and Renal Insufficiency, Chronic, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Time Restricted Feeding, Renal Insufficiency, Chronic, Obesity
What is being tested?: Time-restricted feeding(TRF)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteChina
Study dates: 12 Aug 2021to 1 Jul 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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Taking other dietary therapies, undergoing weight loss treatment
Vegetarian
Type 1 diabetes and type 2 diabetes using insulin

Trial locations and contacts

1 site in 1 country.

China1 site

Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120

Other trials in China

About this study

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

Read the 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
Being tested: Time-restricted feeding(TRF)
Keywords: time-restricted feeding, chronic kidney disease, obesity
Medical subject headings: Intermittent Fasting, Renal Insufficiency, Chronic, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Time-restricted feeding(TRF)Behavioural
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.

Study groups in NCT05037747
Study group	Role	What they receive
Time-restricted feeding(TRF)	Experimental	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. Receives: Behavioral: Time-restricted feeding(TRF)
Control	No intervention	The control group was asked to continue their usual low-protein diet eating schedule and pattern.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in eGFR (ml/min/1.73m2)
eGFR at final visit - eGFR at initial visit
Measured: 12 weeks

Secondary outcomes (29)

Changes in body weight (Kilograms)
body weight at final visit - body weight at initial visit
Measured: 12 weeks
Changes in waist circumference (cm)
waist circumference at final visit - waist circumference at initial visit
Measured: 12 weeks
Change in body mass index (kg/m2)
body mass index at final visit - body mass index at initial visit
Measured: 12 weeks
Changes in serum total cholesterol levels (mmol/L)
serum total cholesterol levels at final visit - serum total cholesterol levels at initial visit
Measured: 12 weeks
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
Measured: 12 weeks
Changes in serum triglyceride levels (mmol/L)
serum triglyceride levels at final visit - serum triglyceride levels at initial visit
Measured: 12 weeks
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
Measured: 12 weeks
Changes in serum albumin (g/L)
serum albumin at final visit - serum albumin at initial visit
Measured: 12 weeks
Changes in total serum protein (g/L)
total serum protein at final visit - total serum protein at initial visit
Measured: 12 weeks
Changes in fat free mass (kg)
fat free mass at final visit - fat free mass at initial visit
Measured: 12 weeks
Changes in body fat mass (kg)
body fat mass at final visit - body fat mass at initial visit
Measured: 12 weeks
Changes in percent body fat (%)
percent body fat at final visit - percent body fat at initial visit
Measured: 12 weeks
Changes in waist-hip ratio
waist-hip ratio at final visit - waist-hip ratio at initial visit
Measured: 12 weeks
Changes in soft lean mass (kg)
soft lean mass at final visit - soft lean mass at initial visit
Measured: 12 weeks
Changes in visceral fat area (cm2)
visceral fat area at final visit - visceral fat area at initial visit
Measured: 12 weeks
Changes in arm circumference (cm)
arm circumference at final visit - arm circumference at initial visit
Measured: 12 weeks
Changes in triceps skin fold thickness (cm)
triceps skin fold thickness at final visit - triceps skin fold thickness at initial visit
Measured: 12 weeks
Changes in grip strength (kg)
grip strength at final visit - grip strength at initial visit
Measured: 12 weeks
Changes in fasting blood glucose (mmol/L)
fasting blood glucose at final visit - fasting blood glucose at initial visit
Measured: 12 weeks
Changes in serum creatinine (umol/L)
serum creatinine at final visit - serum creatinine at initial visit
Measured: 12 weeks
Changes in blood urea nitrogen (mmol/L)
blood urea nitrogen at final visit - blood urea nitrogen at initial visit
Measured: 12 weeks
Changes in serum uric acid (umol/L)
serum uric acid at final visit - serum uric acid at initial visit
Measured: 12 weeks
Changes in proteinuria creatinine ratio (g/g)
proteinuria creatinine ratio at final visit - proteinuria creatinine ratio at initial visit
Measured: 12 weeks
Changes in serum cystatin C (mg/L)
serum cystatin C at final visit - serum cystatin C at initial visit
Measured: 12 weeks
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
Measured: 12 weeks
Changes in interleukin-6 (pg/mL)
interleukin-6 at final visit - interleukin-6 at initial visit
Measured: 12 weeks
Changes in tumor necrosis factor-α (pg/mL)
tumor necrosis factor-α at final visit - tumor necrosis factor-α at initial visit
Measured: 12 weeks
Changes in C-reactive protein (mg/L)
C-reactive protein at final visit - C-reactive protein at initial visit
Measured: 12 weeks
Changes in species of intestinal flora
species of intestinal flora at final visit - species of intestinal flora at initial visit
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 20211 Jul 2022

First posted8 Sep 2021
Study start12 Aug 2021
Primary completion30 Mar 2022
Study completion1 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Time Restricted FeedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
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)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05037747
Sponsor's protocol ID: YF2021-142
Status last verified: Jul 2022
First submitted: 31 Aug 2021
Last updated: 7 Jul 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Countermeasures to Circadian Misalignment
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Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
Prediabetes
Not yet recruiting
Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women
Obesity (BMI Equal to or >30), Postmenopausal Symptoms

All Time Restricted Feeding trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Time-restricted Feeding on Obese Patients With Chronic Kidney Disease Stage 3-4: a Pilot Study
ClinicalTrials.gov ID: NCT05037747
Acronym / sponsor ID: YF2021-142
Conditions: Time Restricted Feeding, Renal Insufficiency, Chronic, Obesity
Keywords: time-restricted feeding, chronic kidney disease, obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
Study start: 12 Aug 2021 (actual)
Primary completion: 30 Mar 2022 (actual)
Study completion: 1 Jul 2022 (actual)
First posted: 8 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Time-restricted feeding(TRF)	Experimental	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.
Control	No intervention	–The control group was asked to continue their usual low-protein diet eating schedule and pattern.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Time-restricted feeding(TRF)

Primary outcome

Change in eGFR (ml/min/1.73m2)
Time frame: 12 weeks
eGFR at final visit - eGFR at initial visit

29 secondary outcomes

Changes in body weight (Kilograms)
Time frame: 12 weeks
Changes in waist circumference (cm)
Time frame: 12 weeks
Change in body mass index (kg/m2)
Time frame: 12 weeks
Changes in serum total cholesterol levels (mmol/L)
Time frame: 12 weeks
Changes in serum low density lipoprotein cholesterol levels (mmol/L)
Time frame: 12 weeks
Changes in serum triglyceride levels (mmol/L)
Time frame: 12 weeks
Changes in serum high density lipoprotein cholesterol levels (mmol/L)
Time frame: 12 weeks
Changes in serum albumin (g/L)
Time frame: 12 weeks
Changes in total serum protein (g/L)
Time frame: 12 weeks
Changes in fat free mass (kg)
Time frame: 12 weeks
Changes in body fat mass (kg)
Time frame: 12 weeks
Changes in percent body fat (%)
Time frame: 12 weeks
Changes in waist-hip ratio
Time frame: 12 weeks
Changes in soft lean mass (kg)
Time frame: 12 weeks
Changes in visceral fat area (cm2)
Time frame: 12 weeks
Changes in arm circumference (cm)
Time frame: 12 weeks
Changes in triceps skin fold thickness (cm)
Time frame: 12 weeks
Changes in grip strength (kg)
Time frame: 12 weeks
Changes in fasting blood glucose (mmol/L)
Time frame: 12 weeks
Changes in serum creatinine (umol/L)
Time frame: 12 weeks
Changes in blood urea nitrogen (mmol/L)
Time frame: 12 weeks
Changes in serum uric acid (umol/L)
Time frame: 12 weeks
Changes in proteinuria creatinine ratio (g/g)
Time frame: 12 weeks
Changes in serum cystatin C (mg/L)
Time frame: 12 weeks
Changes in total urine urea in 24 hours (mmol/24h)
Time frame: 12 weeks
Changes in interleukin-6 (pg/mL)
Time frame: 12 weeks
Changes in tumor necrosis factor-α (pg/mL)
Time frame: 12 weeks
Changes in C-reactive protein (mg/L)
Time frame: 12 weeks
Changes in species of intestinal flora
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
Individual participant dataSharing planned: No

Related trials for Time Restricted Feeding

Recruiting
Time Restricted Eating for WeIght LoSs MainTenance-2
Weight Loss, Weight Gain
Recruiting
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
Perioperative Care, Intermittent Fasting
Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Active, not recruiting
Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
Prediabetes
Not yet recruiting
Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women
Obesity (BMI Equal to or >30), Postmenopausal Symptoms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xu-sheng Liu, M.M study chair

Guangdong Provincial Hospital of Traditional Chinese Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in eGFR (ml/min/1.73m2) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05037747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.