Prospective study of BiGufasting in obese humans

Phase 1

Recruiting

• Conditions: obesity/overweight

• Registration Number: ITMCTR1900002727
• Lead Sponsor: Cancer Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) male and female subjects aged 18 to 65 years (including 18 and 65 years);
2) waist circumference >=85cm for male subjects, waist circumference >=80cm for female subjects, body mass index (BMI) >=24kg/m2 (BMI= weight (kg)/height 2(m2));
3) absence of spirit (including psychoactive substance abusers) and physical diseases;
4) those who may have mental disorders were excluded by the psychological assessment -- self-rating depression scale (SDS), social avoidance and distress scale (SAD) Hamilton depression and anxiety scale;
5) disregard and hearing impairment, able to complete necessary scales and behavioral tests;
6) agree to participate in this test and sign informed consent.

Exclusion Criteria

1) chronic diseases (such as chronic kidney disease, autoimmune diseases, etc.);
2) patients who are using steroids, immunosuppressants or non-steroidal anti-inflammatory drugs, weight loss drugs;
3) have poor dietary habits, such as smoking more than 5 cigarettes a day, or cannot stop using any tobacco products during the trial;Regular drinkers during the first six months of the trial drank more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40 per cent spirits or 150 mL of wine);
4) had surgery, blood donation or lost more than 400 mL of blood due to other reasons within 3 months before inclusion;
5) the valley has been closed within nearly 1 month;
6) pregnant and lactating women;
7) fasting blood glucose <=3.9mmol /L;Male hemoglobin <120g/L;Female hemoglobin <110g/L;Patients diagnosed with hypertension with systolic blood pressure >=150mmHg and diastolic blood pressure >=90mmHg, or with medication.Patients diagnosed with diabetes with severe complications (e.g., diabetic macroangiopathy, diabetic nephropathy stage IV and after stage IV);
8) patients with serious cardiovascular and cerebrovascular diseases (such as coronary heart disease, atherosclerosis, arrhythmia, etc.), respiratory diseases, digestive diseases or metabolic diseases (such as hypothyroidism, Cushing's syndrome, etc.), or those who have been hospitalized for the above diseases within the past three months;
9) patients with psychiatric diseases, tuberculosis, hepatitis b surface antigen (HBsAg), hepatitis c virus antibody (HCV), syphilis, human immunodeficiency virus (HIV) antibody positive;
10) patients with specific trauma and local skin ulcer infection.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood pressure;blood fat;blood routine index;height;thyroid function;renal function;hip circumference;heart rate;waist circumference;weight;stool for routine;fasting blood glucose;liver function;routine urine examination ;