A 10-Hour eating window may help reverse early Heart-Kidney-Metabolic syndrome

NCT ID NCT07722338

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether a simple 10-hour time-restricted eating schedule, combined with health education, can improve early-stage cardiovascular-kidney-metabolic (CKM) syndrome in adults aged 30–79 who do not yet need medication. Participants in the intervention group eat all their food and drinks within a fixed 10-hour daytime window each day for six months, while a control group follows their usual routine. The study measures whether this approach can lower CKM stage and improve related health markers like blood pressure, weight, and blood sugar.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a 10-hour time-restricted eating regimen combined with health education and behavioral support
What this could lead to
If effective, this simple eating schedule could offer a drug-free way to improve early-stage cardiovascular-kidney-metabolic syndrome and reduce future heart and kidney risks.
What could go wrong
This is a relatively small community-based trial, and adherence to the eating window may be challenging. Results may not apply to people with more advanced disease or those needing medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age and residence Aged 30 to 79 years at enrollment. Has resided in the study area for at least 6 months and intends to remain in the area throughout the study period. 2. Cardiovascular-kidney-metabolic status Classified as having stage 1 or stage 2 cardiovascular-kidney-metabolic syndrome according to the 2023 American Heart Association staging framework. Assessed by a study physician as not currently having an indication for pharmacological treatment of a cardiovascular, kidney, or metabolic condition. 3. Criteria indicating no current indication for pharmacological treatment. Participants must meet all of the following conditions: No history or current diagnosis of clinical cardiovascular disease, diabetes mellitus, chronic kidney disease, or glomerular disease. Serum albumin concentration of at least 3.5 g/dL, with no clinical or laboratory evidence suggestive of glomerular disease, severe liver disease, malnutrition, or another systemic condition requiring specialist evaluation or treatment. No use during the previous 3 months of medications for cardiovascular, kidney, or metabolic conditions, including antihypertensive agents, glucose-lowering medications, lipid-lowering agents, anti-obesity medications, sodium-glucose cotransporter-2 inhibitors, glucagon-like peptide-1 receptor agonists, or medications with similar therapeutic purposes. Medication use is assessed through participant interview and review of prescriptions or medical records when available. Mean blood pressure below 140/90 mmHg, measured using a standardized study protocol. For participants with a mean systolic blood pressure of 130-139 mmHg or a mean diastolic blood pressure of 80-89 mmHg, the estimated 10-year total cardiovascular disease risk calculated using the PREVENT equation must be below 7.5%. Fasting plasma glucose below 126 mg/dL and glycated hemoglobin below 6.5%. Low-density lipoprotein cholesterol below 190 mg/dL. Estimated glomerular filtration rate of at least 60 mL/min/1.73 m² and urinary albumin-to-creatinine ratio below 30 mg/g. Body mass index below 30 kg/m². Recruitment will preferentially approach overweight individuals with a body mass index of at least 23 kg/m², but this is not a mandatory eligibility requirement when all other criteria are met. 4. Ability to participate in the intervention Has access to a smartphone and is able to use Zalo or an eating-time monitoring application. Is able to complete an eating-time diary and attend scheduled health education, counseling, and assessment sessions. 5. Informed consent and study commitment Voluntarily agrees to participate and provides written informed consent after receiving adequate study information. Agrees to participate in the intervention and follow-up for 6 months, with assessments at baseline, 3 months, and 6 months Exclusion Criteria: Individuals with cardiovascular-kidney-metabolic syndrome stage 0, stage 3, or stage 4, or those with stage 1 or stage 2 who have a current physician-determined indication for pharmacological treatment according to applicable clinical guidelines, are excluded.

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Conditions

The condition(s) this trial relates to.

cardiovascular-kidney-metabolic syndrome Health Education Intermittent Fasting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Can Tho University of Madicine and Pharmacy

    Can Tho, Can Tho City, 900000, Vietnam