Obesity
Conditions
Interventions
Experimental group:Wear a dedicated nasal clip loaded with a sustained-release hydrogel containing active a-KV compounds. Administer the intervention three times daily, before breakfast, lunch, and di
Control group:The nasal clip contains only hydrogel without the active a-KV compound, while all other experimental conditions and intervention measures remain consistent with the experimental group. T
Sponsors
Shandong First Medical University Affiliated Central Hospital (Jinan Central Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Individuals aged >=18 years and = 28 kg/m^2, or 24 kg/m^2 <= BMI < 28 kg/m^2 with at least one weight-related comorbidity (e.g., hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease, etc.); 3. The individual is able to fully understand the informed consent form, agrees to participate in the study, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participation in other clinical trials within the past three months; 2. Use of medications affecting body weight within the 3 months prior to screening, including glucagon-like peptide-1 agonists, steroids, metformin, sodium-glucose cotransporter 2 inhibitors, sibutramine hydrochloride, creatine, etc.; 3. History of bariatric surgery prior to screening; 4. Receipt of any non-pharmacological weight loss treatments within the 3 months prior to screening, including but not limited to acupuncture, catgut embedding, massage, and other non-drug therapies; 5. Presence of psychiatric disorders (e.g., severe depression, anxiety disorders, schizophrenia, etc.) or cognitive impairments (e.g., dementia, etc.) that may hinder compliance with study requirements and completion of relevant assessments and procedures; 6. History of nasal diseases (e.g., deviated nasal septum, nasal polyps, severe rhinitis, etc.) or nasal surgery that may affect the normal wearing of nasal clips and the absorption of odor molecules; 7. Pregnant or breastfeeding women, as well as women planning to become pregnant during the study period; 8. Presence of any other factors that may affect the evaluation of the efficacy or safety of this study; 9. Individuals with hyposmia, defined as a baseline TDI Score < 30 points.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Composition Indicators (Changes in fat mass, body fat percentage, visceral fat area (measured by DXA), waist circumference, etc.);Glucose and lipid metabolism indicators (Changes in fasting glucose, insulin, HOMA-IR, total cholesterol, triglycerides, LDL-C, HDL-C, HbA1c, etc.);Appetite and eating behavior scores (changes in Visual Analog Scale [VAS] ratings for hunger/satiety and Three-Factor Eating Questionnaire [TFEQ] scores);Energy metabolism parameters (resting metabolic rate, RMR); | — |
Countries
China
Contacts
Public ContactYongfeng Song;Xianghang Luo
Shandong First Medical University Affiliated Central Hospital (Jinan Central Hospital)
Outcome results
None listed