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

NCT04475822 | Completed

• 1 other identifier: XJTU1AF2020LSK-003
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• weight

  kg

  Three months after the intervention

• body fat

  Three months after the intervention

Secondary Outcomes (4)

• blood pressure

  Three months after the intervention

• blood glucose

  Three months after the intervention

• blood lipid

  Three months after the intervention

• uric acid

  Three months after the intervention

Study Arms (3)

Intermittent fasting

EXPERIMENTAL

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.

Behavioral: Intermittent fasting

Low carb diet

EXPERIMENTAL

According to the definition of low carbon diet given by R. D. Feinman et al. (Nutrition, 2015), 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.

Behavioral: Low carb diet

Low carbon diet and intermittent fasting group

EXPERIMENTAL

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

Behavioral: Low carbon diet and intermittent fasting group

Interventions

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.

Also known as: Low carb diet, Low carbon diet and intermittent fasting group

Intermittent fasting

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 carb 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.

Low carbon diet and intermittent fasting group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• The Hospital for Sick Children: collaborator
• Leiden University: collaborator

Study Sites (1)

First Affiliated Hospital of Xi an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (3)

• Zheng Y, Wang J, Liu M, Zhou X, Lin X, Liang Q, Yang J, Zhang M, Chen Z, Li M, Wang Y, Sui J, Qiang W, Guo H, Shi B, He M. 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. BMC Med. 2024 Sep 4;22(1):362. doi: 10.1186/s12916-024-03595-6.

  PMID: 39227921 DERIVED

• Zheng Y, Wang X, Wang J, Yang J, Wang T, Li Q, Zhu W, Wang Y, Sui J, Qiang W, Guo H, Wang Y, Shi B, He M. 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. Clin Nutr. 2024 Oct;43(10):2316-2324. doi: 10.1016/j.clnu.2024.08.029. Epub 2024 Aug 30.

  PMID: 39226719 DERIVED

• He M, Wang J, Liang Q, Li M, Guo H, Wang Y, Deji C, Sui J, Wang YW, Liu Y, Zheng Y, Qian B, Chen H, Ma M, Su S, Geng H, Zhou WX, Guo X, Zhu WZ, Zhang M, Chen Z, Rensen PCN, Hui CC, Wang Y, Shi B. Time-restricted eating with or without low-carbohydrate diet reduces visceral fat and improves metabolic syndrome: A randomized trial. Cell Rep Med. 2022 Oct 18;3(10):100777. doi: 10.1016/j.xcrm.2022.100777. Epub 2022 Oct 10.

  PMID: 36220069 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bingyin Shi

  First Affilicated Hospital of Xian Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 17, 2020
• Study Start: July 12, 2020
• Primary Completion: January 31, 2021
• Study Completion: June 30, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

CN (1)