Status:
COMPLETED
Efficacy and Safety of Low-Carbohydrate Diet Combined With Probiotics for Weight Loss in Male Obese Patients.
Lead Sponsor:
Sun Jia
Conditions:
Obesity
Eligibility:
MALE
18-35 years
Phase:
NA
Brief Summary
Over the years, increasing obesity prevalence represents an important threat to national and global public health. Many strategies studied for weight loss have reported that low-carbohydrate diets sho...
Detailed Description
This study is a randomized, double-blind, placebo-controlled clinical trial. According to the preliminary experimental results, the decrease in weight of the experimental group intervening by low-carb...
Eligibility Criteria
Inclusion
- Male;
- 18 to 35 years old;
- BMI≥28kg/m2;
- No contraindications for MRI examination;
- No alcohol intake, no use of any probiotic-related foods or medications, antibiotics, hormones and weight-loss products in the past three months;
- No other metabolic diseases;
- Volunteering to participate in and cooperate with the research and sign the written informed consent.
Exclusion
- Subjects suffered from Secondary obesity including hypercortisolism, hypothyroidism, insulinoma, drug-induced obesity, etc.
- Obesity-related complications that may be life-threatening or cause serious consequences in the short term have occurred.
- Any of the following cardiovascular diseases have occurred in the past：
- Myocardial infarction.
- Cerebral infarction.
- Cardiac or revascularization surgery such as coronary artery bypass graft surgery and percutaneous transluminal coronary angioplasty.
- Unstable angina pectoris;
- Congestive heart failure diagnosed as Class III or IV of the New York Heart Association.
- Transient ischemic attack or significant cerebrovascular disease.
- Patients with symptoms of gastrointestinal diseases, including intestinal obstruction, intestinal ulcer and gastrointestinal bleeding.
- A history of gastrointestinal surgery, such as bariatric surgery, banding surgery, gastrointestinal anastomosis and enterectomy.
- A state of known immunodeficiency, including but not limited to individuals who have experienced organ transplantation or acquired immunodeficiency syndrome (AIDS).
- Subjects who cannot comply with the protocol and patients with serious physical or psychological diseases that may affect the effectiveness or safety under the judgment of the investigator.
- Patients who cannot cooperate to complete the entire intervention and follow-up due to various other factors.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04886778
Start Date
June 1 2021
End Date
March 1 2022
Last Update
March 13 2024
Active Locations (1)
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1
The Pearl River Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510300