Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT04140851
Eligibility Criteria:
Inclusion Criteria:
* for the overweight/obesity group. Diagnostic criteria for overweight or obesity (basis): The classification standard% for the body mass index of Chinese population \[(BMI) = weight (kg)/height square (m\^2)\] recommended by the Working Group on Obesity of China (WGOC): obesity: BMI ≥ 28 kg/m\^2; overweight: 28 kg/m\^2 \> BMI ≥ 24 kg/m\^2; normal weight: 24 kg/m\^2 \> BMI ≥18.5 kg/m\^2; underweight: BMI \< 18.5 kg/m\^2;
* The subjects had not received weight loss treatment such as being on diet, diet drugs or surgery 6 months before the enrollment;
* The subjects signed the informed consent form, and were able and willing to adhere to low-carbohydrate diet and receive regular call and outpatient follow-up;
Exclusion Criteria:
* pregnant women, lactating women or women planning to get pregnant;
* the obesity caused by endocrine system and central nervous system diseases or drugs, type 2 diabetes, autoimmune diseases and other endocrine systemic diseases;
* history of acute or chronic infection, surgery or trauma, or history of malignant tumor;
* severe liver and kidney dysfunction (transaminase \> 2.5 times of normal upper limit); creatinine: male ≥ 133 μmol/L; female ≥ 124 μmol/L;
* the patients with severe heart, brain or peripheral vascular diseases;
* Those unable to cooperate with the observer for various reasons.
The subjects withdrew from the criteria:
* being unable to continue the intervention due to other reasons or diseases during the treatment;
* being unsatisfied with the improvement in the symptoms during the treatment and requiring to stop the trial;
* having serious adverse events or adverse reactions, and the investigator considers it is necessary for the subject to terminate the trial from the medical perspective.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04140851
Study Brief:
Protocol Section:
NCT04140851