Status:
COMPLETED
The Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics
Lead Sponsor:
Shenzhen Precision Health Food Technology Co. Ltd.,
Conditions:
Overweight and Obesity
Eligibility:
All Genders
25-45 years
Phase:
NA
Brief Summary
The goal of this interventional study is to test whether consumption of Wonderlab probiotics with prebiotics could improve obesity and overweight in Chinese people who are aged 25-45 and overweight. T...
Eligibility Criteria
Inclusion
- Chinese males or females, age between 25-45;
- Overweight population: BMI 24-27.9 \& obesity population: BMI \>=28;
- Blood lipids in high potential risks but without medication:TG \> 5mmol/L or LDL \>= 3.4 mmol/L or TC \>= 5.2 mmol/L.
- Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate;
- Agree to avoid medication treatment for weight management, including blood lipids and sugar control.
Exclusion
- Have used any medication for weight management at least one month before this study.
- Subject having done plastic surgery for weight management.
- Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
- Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
- Have a history of any type of metabolic syndrome, including but not limited to any type of diabetes, obesity and heart disease.
- Have a history of any disease or the presence of health condition on the study sites that the Investigator feels would interfere with the study.
- Be taking antihistamines (\> 3x/week) or anti-inflammatory (\> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment.
- Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, pregnancy, lactation and hepatitis.
- Have any cuts/abrasions on the test site at baseline.
- The subject is an employee of sponsor or the site conducting the study.
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06030999
Start Date
September 18 2023
End Date
December 15 2023
Last Update
February 21 2024
Active Locations (2)
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1
SPRIM Central Lab
Shanghai, Shanghai Municipality, China
2
Ligang Hospital
Jinhua, Zhejiang, China