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A Randomized, Parallel-Controlled, Pilot Study on the Intervention Effect of 2-oxovaleric Acid in Subjects with Overweight or Obesity

A Randomized, Parallel-Controlled, Pilot Study on the Intervention Effect of 2-oxovaleric Acid in Subjects with Overweight or Obesity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107254
Enrollment
Unknown
Registered
2025-08-07
Start date
2025-08-12
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Healthy population control group (Part I):There is only hydrogel and PBS in the nasal clip, and no 2-oxovaleric acid liquid solvent. Other experimental conditions and intervention measures are consist
Healthy population low-concentration test group (Part I):Subjects wore U-shaped nasal clips containing a mixture of 2-oxovaleric acid liquid solvent and hydrogel. The low-concentration group had an av
High concentration test group in healthy people (Part I):Subjects wore U-shaped nasal clips containing a mixture of 2-oxovaleric acid liquid solvent and hydrogel. The low-concentration group had an av
Overweight and obese control group (Part II):There is only hydrogel in the nasal clip, and no 2-oxovaleric acid liquid solvent. Other experimental conditions and intervention measures are consistent w
Overweight and obese people (Part II):Wearing a U-shaped nasal clip containing a mixture of 2-oxovaleric acid

Sponsors

The Affiliated Central Hospital of Shandong First Medical University (Jinan Central Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. People with > age = 18 years old and < = 65 years old and normal olfactory function; 2. No family history of hereditary obesity; 3. Good compliance with the experiment; 4. The patient himself or close relatives can fully understand the informed consent form, agree to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have participated in any drug clinical trial within 3 months before the trial; 2. Those with chronic or active gastrointestinal diseases such as esophageal diseases, gastritis, gastric ulcers, enteritis, active gastrointestinal bleeding or gastrointestinal surgery within three years; 3. Those who have a history of cardiovascular system, endocrine system (thyroid dysfunction, Cushing's disease, etc.), urinary system, nervous system, respiratory system, hematology, immunology (including personal or family history of hereditary immune deficiencies), psychiatry, etc., and the investigator believes that it is still clinically significant; 4. Those with a history of allergies to drugs, food or other substances; 5. Those with a history of tumor, epilepsy, recurrent headache, and Mycobacterium tuberculosis infection; 6. Those who cannot tolerate venous perforation or have a history of blood sickness or needle sickness; 7. Surgical operation within 3 months before the test; or those who plan to undergo surgical procedures during the study; 8. Those who have been vaccinated within 3 months before the trial; 9. Those who have used any drug within 30 days before the test; 10. Blood donors or large blood loss within 3 months before the test (>400 mL); 11. Heavy drinkers or regular drinkers within 6 months prior to the trial, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine); or those who are unwilling to stop drinking alcohol or using any alcohol-containing products during the trial; or a positive alcohol breath test result (>0.0 mg/100 mL); 12. Those who drink excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day, or those who do not agree to stop drinking tea, coffee and/or caffeinated beverages during the trial; 13. Drug abusers or those who have used soft drugs (such as marijuana) within 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial; 14. Creatinine clearance 12 hours (standardized pretreatment is required); 21. Subjects may not be able to complete the study due to other reasons or have other reasons that are not suitable for participating in the trial as judged by the investigator; 22. People with hyposmia with a baseline TDI score of <30.

Design outcomes

Primary

MeasureTime frame
Weight;

Secondary

MeasureTime frame
Body composition;

Countries

China

Contacts

Public ContactYongfeng Song

The Affiliated Central Hospital of Shandong First Medical University (Jinan Central Hospital)

syf198506@163.com+86 188 7415 5802

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026