Study on the Mechanism of Regulating Gut Microbiome in Obese People by Regulating Brain-gut Axis With Fast Diet

1. 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.
2. 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.
3. 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.

Study Overview

• Status: Completed
• Conditions: Obesity; Magnetic Resonance Imaging; Gastrointestinal Microbiome
• Intervention / Treatment: Other: Fast diet

Detailed Description

1. 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).
2. 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.
3. 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. BMI greater than or equal to 28 kg/m2, waist circumference greater than or equal to 90cm for men and 85cm for women.
2. Aged between 18 and 60.
3. 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.
4. 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:

1. 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.
2. 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.
3. special groups such as female menstruation, minors, pregnant women, and the elderly over 60 years old.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ReHo	Reho of brain after 1 month of fast diet	1 month
ReHo	Reho of brain after 2 month of fast diet	2 month
Adiponectin	Adiponectin after 1 month of fast diet	1 month
Adiponectin	Adiponectin after 2 month of fast diet	2 month
Gut microbiome	the change of gut microbiome after 1 month of fast diet	1 month
Gut microbiome	the change of gut microbiome after 2 month of fast diet	2 month
body mass	the change of body mass after 1 month of fast diet	1 month
body mass	the change of body mass after 2 month of fast diet	2 month

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2018
• Primary Completion (ACTUAL): July 31, 2018
• Study Completion (ACTUAL): July 31, 2018

Study Registration Dates

• First Submitted: December 27, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (ACTUAL): December 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Obesity；Gut microbiome；Task fMRI;Brain-Gut axis
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 20180520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No