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

NCT ID: NCT04475822

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-12
• Study Completion Date: 2022-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intermittent fasting

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.

Group Type: EXPERIMENTAL

Intermittent fasting

Intervention Type: 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.

Low carb diet

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.

Group Type: EXPERIMENTAL

Low carb diet

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Low carbon diet and intermittent fasting group

Intervention Type: 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.

Interventions

Intermittent fasting

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.

Intervention Type: BEHAVIORAL

Low carb diet

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.

Intervention Type: BEHAVIORAL

Low carbon diet and intermittent fasting group

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Low carb diet; Low carbon diet and intermittent fasting group

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5):

1. Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women).

2. Elevated TG (use of medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L).

3. 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.

4. Elevated blood pressure (use of hypoglycemic medications is an alternate indicator). SBP ≥ 130 and/or DBP ≥ 85 mmHg.

5. Elevated FBG (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).

2. Age from 18 to 65 years.

3. Stable weight (change ≤ 10% current body weight) for 3 months prior to the study.

4. 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

1. Pregnant or breast-feeding.

2. Night shift workers.

3. 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.

4. Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite.

5. History of weight-loss surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

Leiden University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bingyin Shi

Role: STUDY_CHAIR

First Affilicated Hospital of Xian Jiaotong University

Locations

First Affiliated Hospital of Xi an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39227921 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39226719 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36220069 (View on PubMed)

Other Identifiers

XJTU1AF2020LSK-003

Identifier Type: -

Identifier Source: org_study_id