ObesityNCT04691583
Study on the Mechanism of Regulating Gut Microbiome in Obese People by Regulating Brain-gut Axis With Fast Diet
A study testing Fast diet in people with Obesity and Gastrointestinal Microbiome, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Gastrointestinal Microbiome, Magnetic Resonance Imaging
- What is being tested?
- Fast diet
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2018to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
Read the 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.
- Being tested
- Fast diet
- Keywords
- Obesity；Gut microbiome；Task fMRI;Brain-Gut axis
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast dietOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
ReHo
Reho of brain after 1 month of fast diet
Measured: 1 month
ReHo
Reho of brain after 2 month of fast diet
Measured: 2 month
Adiponectin
Adiponectin after 1 month of fast diet
Measured: 1 month
Adiponectin
Adiponectin after 2 month of fast diet
Measured: 2 month
Gut microbiome
the change of gut microbiome after 1 month of fast diet
Measured: 1 month
Gut microbiome
the change of gut microbiome after 2 month of fast diet
Measured: 2 month
body mass
the change of body mass after 1 month of fast diet
Measured: 1 month
body mass
the change of body mass after 2 month of fast diet
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start11 Apr 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691583
- Sponsor's protocol ID
- 20180520
- Status last verified
- Dec 2020
- First submitted
- 27 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mechanism of Regulating Gut Microbiome in Obese People by Regulating Brain-gut Axis With Fast Diet
- ClinicalTrials.gov ID
- NCT04691583
- Acronym / sponsor ID
- 20180520
- Keywords
- Obesity；Gut microbiome；Task fMRI;Brain-Gut axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- 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.
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast dietFast 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. | Other | – |
Primary outcome
ReHo
Time frame: 1 month
Reho of brain after 1 month of fast diet
ReHo
Time frame: 2 month
Reho of brain after 2 month of fast diet
Adiponectin
Time frame: 1 month
Adiponectin after 1 month of fast diet
Adiponectin
Time frame: 2 month
Adiponectin after 2 month of fast diet
Gut microbiome
Time frame: 1 month
the change of gut microbiome after 1 month of fast diet
Gut microbiome
Time frame: 2 month
the change of gut microbiome after 2 month of fast diet
body mass
Time frame: 1 month
the change of body mass after 1 month of fast diet
body mass
Time frame: 2 month
the change of body mass after 2 month of fast diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast diet in people with Obesity and Gastrointestinal Microbiome, run by Henan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ReHo (time frame: 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.