Back to resultsExplore the Effect of Diet Intervention on Lipid Metabolism and Body Mass Index Among the Patients With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intermittent fasting
Low carb diet
Low carbon diet and intermittent fasting group
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
Eligibility Criteria
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.
Sites / Locations
- First Affiliated Hospital of Xi an Jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Intermittent fasting
Low carb diet
Low carbon diet and intermittent fasting group
Arm Description
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.
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.
Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.
Outcomes
Primary Outcome Measures
weight
kg
body fat
Secondary Outcome Measures
blood pressure
mmHg
blood glucose
mmol/L
blood lipid
mmol/L
uric acid
µmol/L
Full Information
NCT ID
NCT04475822
First Posted
July 15, 2020
Last Updated
July 7, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
The Hospital for Sick Children, Leiden University
1. Study Identification
Unique Protocol Identification Number
NCT04475822
Brief Title
Explore the Effect of Diet Intervention on Lipid Metabolism and Body Mass Index Among the Patients With Metabolic Syndrome
Official Title
An Intervention Study of Intermittent Fasting and Low Carbon Diet in Patients With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 12, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
The Hospital for Sick Children, Leiden University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intermittent fasting
Arm Type
Experimental
Arm Description
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.
Arm Title
Low carb diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Low carbon diet and intermittent fasting group
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Intermittent fasting
Other Intervention Name(s)
Low carb diet, Low carbon diet and intermittent fasting group
Intervention Description
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
Intervention Name(s)
Low carb diet
Intervention Description
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
Intervention Name(s)
Low carbon diet and intermittent fasting group
Intervention Description
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 Outcome Measure Information:
Title
weight
Description
kg
Time Frame
Three months after the intervention
Title
body fat
Time Frame
Three months after the intervention
Secondary Outcome Measure Information:
Title
blood pressure
Description
mmHg
Time Frame
Three months after the intervention
Title
blood glucose
Description
mmol/L
Time Frame
Three months after the intervention
Title
blood lipid
Description
mmol/L
Time Frame
Three months after the intervention
Title
uric acid
Description
µmol/L
Time Frame
Three months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bingyin Shi
Organizational Affiliation
First Affilicated Hospital of Xian Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xi an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
36220069
Citation
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.
Results Reference
derived
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Explore the Effect of Diet Intervention on Lipid Metabolism and Body Mass Index Among the Patients With Metabolic Syndrome
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