Obesity
Conditions
Interventions
a-KV group:Wear a specialized nasal clip containing a sustained-release hydrogel loaded with a defined amount of a-KV. a-KV is continuously released during wearing through the hydrogel and microporous
Control group:Wear a placebo nasal clip identical in appearance, material, and mode of use. The placebo nasal clip contains sweet almond oil as an odorized control component but no a-KV.
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. Age >=18 years and =65 years, male or female; 2. BMI >=28 kg/m², or 24 kg/m² <= BMI <28 kg/m² with at least one weight-related comorbidity (e.g., hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease); 3. Normal olfactory function and able to complete olfactory assessments; 4. Able to fully understand the informed consent form, voluntarily participate in the study, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial within the past three months; 2. Use of medications that may significantly affect body weight or energy metabolism, such as GLP-1 receptor agonists, glucocorticoids, or anti-obesity drugs, within 3 months prior to screening; 3. Prior history of bariatric surgery, or receipt of other intensive weight interventions that may affect body weight within 3 months prior to screening; 4. Prior history of diabetes mellitus; 5. Presence of severe mental illness, cognitive impairment, or other conditions that may affect compliance and outcome assessment; 6. Presence of nasal disorders (e.g., deviated nasal septum, nasal polyps, severe rhinitis) or a history of nasal surgery that may interfere with proper wearing of the nasal clip and odor perception; 7. Known allergy to any study-related components, nasal clip materials, or related excipients; 8. Women who are pregnant, lactating, or planning to become pregnant during the study period; 9. Presence of severe systemic diseases involving the heart, liver, kidneys, or other organ systems, or other conditions that, in the investigator's judgment, render the subject unsuitable for enrollment and may affect safety and efficacy evaluations; 10. Impaired olfactory function at baseline (e.g., TDI score < 30 points).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition indicators;glucose and lipid metabolism indicators:(fasting glucose, insulin, HOMA-IR, total cholesterol, triglycerides, LDL-C, HDL-C, and HbA1c);Appetite and behavior scores: changes in Visual Analog Scale (VAS) hunger/satiety scores and Three-Factor Eating Questionnaire (TFEQ) scores.; | — |
Countries
China
Contacts
Public ContactYongfeng Song; Xianghang Luo
Shandong First Medical University Affiliated Central Hospital (Jinan Central Hospit
Outcome results
None listed