Overweight and Obesity
Conditions
Interventions
Experimental group:receives a cellulose enhancing capsules (composed of cross-linked hydrogel particles and a gelatin capsule shell)
Control group:receives cellulose enhancing capsules (Placebo) (composed of edible corn starch and a gelatin capsule shell)
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 80 years; 2. Individuals considered by the investigator to have a need for weight control through dietary reduction; 3. Body mass index (BMI) between 25 kg/m² and 40 kg/m² (25 = BMI < 40); 4. Voluntarily sign the informed consent form and agree to complete the scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Patients with acute gastrointestinal diseases; 2. Patients currently receiving other weight-loss treatments; 3. Patients with diabetes mellitus; 4. Participation in another clinical trial within 1 month prior to signing informed consent; 5. Pregnant or breastfeeding women, or those planning to become pregnant during the trial period; 6. Allergy to cellulose; 7. Patients with AIDS or a history of cancer within the past 5 years; 8. Renal insufficiency (abnormal serum creatinine); 9. Hepatic impairment: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3× upper limit of normal, or total bilirubin (TBIL) > 3 × upper limit of normal; 10. Any other condition that the investigator deems unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Hunger Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastric Emptying Time;Appetite Score;Percentage of Body Weight Loss; | — |
Countries
China
Contacts
Public ContactShen Qu
Shanghai Tenth People's Hospital
Outcome results
None listed