Back to resultsStudy on the Mechanism of Regulating Gut Microbiome in Obese People by Regulating Brain-gut Axis With Fast Diet
Primary Purpose
Obesity, Gastrointestinal Microbiome, Magnetic Resonance Imaging
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fast diet
Sponsored by
About this trial
This is an interventional other trial for Obesity focused on measuring Obesity；Gut microbiome；Task fMRI;Brain-Gut axis
Eligibility Criteria
Inclusion Criteria:
- BMI greater than or equal to 28 kg/m2, waist circumference greater than or equal to 90cm for men and 85cm for women.
- Aged between 18 and 60.
- Patients may be accompanied by diseases such as abnormal blood pressure, abnormal blood lipid, abnormal uric acid, metabolic syndrome, respiratory sleep, constipation, etc., but they can only participate in these diseases if there is no obvious risk after clinical evaluation.
- No serious heart, brain, liver and kidney dysfunction, uremia coma, ketoacidosis, hypoglycemia, anemia, malnutrition, hematopoietic system and body immune system diseases, infectious diseases, neurological diseases.
5, the body does not contain the implantation or other metal materials such as the implantable metal denture, cardiac pacemaker, artificial joint, insulin pump and so on, no claustrophobia, non-pregnancy, suitable for magnetic resonance examination to participate in.
Exclusion Criteria:
- those who do not meet the above diagnostic criteria have poor compliance and have not signed a voluntary informed consent to participate in the experimental study.
- patients with severe cardiac, cerebral, hepatic and renal dysfunction, uremia coma, ketoacidosis, hypoglycemia, anemia, malnutrition, hematopoietic system and physical immune system diseases, infectious diseases, neurological diseases, etc.
- special groups such as female menstruation, minors, pregnant women, and the elderly over 60 years old.
Sites / Locations
- Henan Provincial People's Hospital
Outcomes
Primary Outcome Measures
ReHo
Reho of brain after 1 month of fast diet
ReHo
Reho of brain after 2 month of fast diet
Adiponectin
Adiponectin after 1 month of fast diet
Adiponectin
Adiponectin after 2 month of fast diet
Gut microbiome
the change of gut microbiome after 1 month of fast diet
Gut microbiome
the change of gut microbiome after 2 month of fast diet
body mass
the change of body mass after 1 month of fast diet
body mass
the change of body mass after 2 month of fast diet
Secondary Outcome Measures
Full Information
NCT ID
NCT04691583
First Posted
December 27, 2020
Last Updated
December 29, 2020
Sponsor
Henan Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04691583
Brief Title
Study on the Mechanism of Regulating Gut Microbiome in Obese People by Regulating Brain-gut Axis With Fast Diet
Official Title
Study on the Mechanism of Regulating Gut Microbiome in Obese People by Regulating Brain-gut Axis With Fast Diet
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Provincial People's Hospital
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
Normal diet：Starting from May 20, 2018, the subjects will eat a normal diet for 4 days, with no restriction on calories and food types. The subjects are required to record their daily diet and dietary intake of calories.
Fast diet of High control ：From May 24, 2018, the method of fast diet was adopted on alternate days. According to the dietary records of normal diet, the normal caloric intake of each subject was calculated. Fast diet was carried out according to 2/3, 1/2, 1/3 and 1/4 of the original normal caloric intake.Each caloric stage last for 4 days, and the total cycle of fast diet was 31 days.
Fast diet of Low control ：After the intervention of fast diet of high control, the subjects were allowed to continue the diet fast diet every other day. It was suggested that the daily caloric intake was 600kal/ day for males and 500kal/ day for females.
Detailed Description
Normal diet: the course of treatment was 4 days. The subjects were asked to record the daily diet and dietary intake in the daily observation scale (Table 1).
High control diet intervention: the course of treatment was 31 days. According to the actual intake of calories, 2 / 3, 1 / 2, 1 / 3 and 1 / 4 of the actual intake of the subjects were calculated as the light fasting calories. The treatment course of each calorie stage was 4 days. The subjects recorded the daily diet and dietary intake, and the nutritionists calculated the daily calorie intake and dietary types of each subject according to the daily calorie intake of each subject's normal diet. During the period of high control diet intervention, the diet on the day of light fasting was provided by the research group. Besides the diet provided by the research group, other foods (except water without calories) were strictly prohibited on the day of light fasting.
Low control diet intervention: the course of treatment was 31 days. It is suggested that the calorie intake of men and women should be 600 kcal / day and 500 kcal / day on the day of light fasting. The diet type can refer to the recipe made by the nutritionist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Gastrointestinal Microbiome, Magnetic Resonance Imaging
Keywords
Obesity；Gut microbiome；Task fMRI;Brain-Gut axis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Normal diet：Starting from May 20, 2018, the subjects will eat a normal diet for 4 days, with no restriction on calories and food types. The subjects are required to record their daily diet and dietary intake of calories.
Fast diet of High control ：From May 24, 2018, the method of fast diet was adopted on alternate days. According to the dietary records of normal diet, the normal caloric intake of each subject was calculated. Fast diet was carried out according to 2/3, 1/2, 1/3 and 1/4 of the original normal caloric intake.Each caloric stage last for 4 days, and the total cycle of fast diet was 31 days.
Fast diet of Low control ：After the intervention of fast diet of high control, the subjects were allowed to continue the diet fast diet every other day. It was suggested that the daily caloric intake was 600kal/ day for males and 500kal/ day for females.
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Fast diet
Intervention Description
Fast diet of High control ：From May 24, 2018, the method of fast diet was adopted on alternate days. According to the dietary records of normal diet, the normal caloric intake of each subject was calculated. Fast diet was carried out according to 2/3, 1/2, 1/3 and 1/4 of the original normal caloric intake.Each caloric stage last for 4 days, and the total cycle of fast diet was 31 days.
Fast diet of Low control ：After the intervention of fast diet of high control, the subjects were allowed to continue the diet fast diet every other day. It was suggested that the daily caloric intake was 600kal/ day for males and 500kal/ day for females.
Primary Outcome Measure Information:
Title
ReHo
Description
Reho of brain after 1 month of fast diet
Time Frame
1 month
Title
ReHo
Description
Reho of brain after 2 month of fast diet
Time Frame
2 month
Title
Adiponectin
Description
Adiponectin after 1 month of fast diet
Time Frame
1 month
Title
Adiponectin
Description
Adiponectin after 2 month of fast diet
Time Frame
2 month
Title
Gut microbiome
Description
the change of gut microbiome after 1 month of fast diet
Time Frame
1 month
Title
Gut microbiome
Description
the change of gut microbiome after 2 month of fast diet
Time Frame
2 month
Title
body mass
Description
the change of body mass after 1 month of fast diet
Time Frame
1 month
Title
body mass
Description
the change of body mass after 2 month of fast diet
Time Frame
2 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI greater than or equal to 28 kg/m2, waist circumference greater than or equal to 90cm for men and 85cm for women.
Aged between 18 and 60.
Patients may be accompanied by diseases such as abnormal blood pressure, abnormal blood lipid, abnormal uric acid, metabolic syndrome, respiratory sleep, constipation, etc., but they can only participate in these diseases if there is no obvious risk after clinical evaluation.
No serious heart, brain, liver and kidney dysfunction, uremia coma, ketoacidosis, hypoglycemia, anemia, malnutrition, hematopoietic system and body immune system diseases, infectious diseases, neurological diseases.
5, the body does not contain the implantation or other metal materials such as the implantable metal denture, cardiac pacemaker, artificial joint, insulin pump and so on, no claustrophobia, non-pregnancy, suitable for magnetic resonance examination to participate in.
Exclusion Criteria:
those who do not meet the above diagnostic criteria have poor compliance and have not signed a voluntary informed consent to participate in the experimental study.
patients with severe cardiac, cerebral, hepatic and renal dysfunction, uremia coma, ketoacidosis, hypoglycemia, anemia, malnutrition, hematopoietic system and physical immune system diseases, infectious diseases, neurological diseases, etc.
special groups such as female menstruation, minors, pregnant women, and the elderly over 60 years old.
Facility Information:
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study on the Mechanism of Regulating Gut Microbiome in Obese People by Regulating Brain-gut Axis With Fast Diet
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