NCT04475822

Explore the Effect of Diet Intervention on Lipid Metabolism and Body Mass Index Among the Patients With Metabolic Syndrome

Completed NA Last updated 11 July 2022

What this trial tests

NA trial testing Intermittent fasting in Metabolic Syndrome in 169 participants. Completed in 30 June 2022.

Timeline

12 July 2020

Primary endpoint
31 January 2021

30 June 2022

Quick facts

Lead sponsor	First Affiliated Hospital Xi'an Jiaotong University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	169
Start date	12 July 2020
Primary completion	31 January 2021
Estimated completion	30 June 2022
Sites	1 location across China

Drugs / interventions tested

• Intermittent fasting
• Low carb diet
• Low carbon diet and intermittent fasting group

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Who can join

Adults 18 to 65, any sex, with Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The prevalence of metabolic syndrome (MetS) is increasing all over the world, which is largely related to the increasing obesity population and the current inactive lifestyle of human beings. It is a common problem facing public health and clinical practice.Metabolic syndrome is an accumulation of biologically metabolic risk factors related to cardiovascular disease and diabetes, including glucose metabolism disorders, hypertension, dyslipidemia, and obesity (especially central obesity).Researchers believe that the common pathological basis of these manifestations is insulin resistance, which is generally considered to be a reduction in the biological effects of insulin compared with the normal biological effects of expected biological phenomena.Nowadays, there are more and more studies on insulin resistance in the world. We have known that age, poor living and eating habits, high blood fat, high blood sugar and stress all lead to insulin resistance.

The researchers hope to reduce weight, reduce body fat rate, improve body fat distribution and insulin resistance, reverse abnormal metabolic indicators, and ultimately reduce the incidence of chronic diseases in patients with metabolic syndrome through the intervention of lifestyle and diet habits in the early stage of the disease.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Time-restricted eating with or without low-carbohydrate diet reduces visceral fat and improves metabolic syndrome: A randomized trial.
   He M, Wang J, Liang Q, Li M, et al · · 2022 · cited 61× · PMID 36220069 · DOI 10.1016/j.xcrm.2022.100777
2. Effects of time-restricted eating and low-carbohydrate diet on psychosocial health and appetite in individuals with metabolic syndrome: A secondary analysis of a randomized controlled trial.
   Zheng Y, Wang X, Wang J, Yang J, et al · · 2024 · cited 9× · PMID 39226719 · DOI 10.1016/j.clnu.2024.08.029
3. Time-restricted eating with or without a low-carbohydrate diet improved myocardial status and thyroid function in individuals with metabolic syndrome: secondary analysis of a randomized clinical trial.
   Zheng Y, Wang J, Liu M, Zhou X, et al · · 2024 · cited 6× · PMID 39227921 · DOI 10.1186/s12916-024-03595-6