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Completed

NCT Number: NCT04475822

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Xi an Jiaotong University

Xi'an, Shaanxi, 710061, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5):
  • Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women).
  • Elevated TG (use of medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L).
  • Reduced HDL-c (use of medications for reduced HDL-c is an alternate indicator) < 40 mg/dL (1.0 mmol/L) in males < 50 mg/dL (1.3 mmol/L) in females.
  • Elevated blood pressure (use of hypoglycemic medications is an alternate indicator). SBP ≥ 130 and/or DBP ≥ 85 mmHg.
  • Elevated FBG (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).
  • Age from 18 to 65 years.
  • Stable weight (change ≤ 10% current body weight) for 3 months prior to the study.
  • If participates were on hypoglycemic medications, hypotensive medications, lipid-lowering medications and cardiovascular medications, dose adjustment was not permitted during the 3-month intervention.

Exclusion criteria

  • Pregnant or breast-feeding.
  • Night shift workers.
  • History of major diseases or related diseases, such as inflammatory disease, rheumatologic disease, adrenal disease, malignancy, type 1 diabetes, cirrhosis, chronic kidney disease, acquired immunodeficiency syndrome, eating disorder, uncontrolled psychiatric disorder and major adverse cardiovascular event.
  • Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite.
  • History of weight-loss surgery.

Treatment and study plan

Intermittent fasting

Behavioral

Intermittent fasting group:During the three-month intervention period, participants were allowed to eat for eight consecutive hours and fast for 16 hours a day.The eating time can be freely chosen in the following two periods: 8:00 -- 16:00;12:00 -- 20:00.No specific restriction shall be made on the type and quantity of food.

Other names: Low carb diet, Low carbon diet and intermittent fasting group

low carb diet

Behavioral

Low carb diet:The daily carbohydrate intake of participants in this group was limited to 130g/ D, and the recommended diet was formulated according to the standard and combined with the local eating habits in Xi 'an, and dietary habit education was conducted. Participants could eat according to the recommended diet.

Low carbon diet and intermittent fasting group

Behavioral

Low carbon diet and intermittent fasting group:Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.

Primary outcomes

  1. weight

    Time frame: Three months after the intervention

    kg

  2. body fat

    Time frame: Three months after the intervention

Secondary outcomes

  1. blood pressure

    Time frame: Three months after the intervention

    mmHg

  2. blood glucose

    Time frame: Three months after the intervention

    mmol/L

  3. blood lipid

    Time frame: Three months after the intervention

    mmol/L

  4. uric acid

    Time frame: Three months after the intervention

    µmol/L

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • Leiden University
  • The Hospital for Sick Children

Registry information

Official study title

An Intervention Study of Intermittent Fasting and Low Carbon Diet in Patients With Metabolic Syndrome

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 17, 2020
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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