Clinical trial NCT06030999: The Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics
Official title: Three Arms, Randomized, Double-blind Controlled Trial Of Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Probiotics
Prebiotics
Wonderlab
Lead sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,
Sponsor class: OTHER_GOV
First posted: 2023-09-11
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. The main question it aims to answer is:

- whether the weight of participants can be lost after 10 weeks' intervention

150 participants will be randomized into 3 study groups (50 each group) in the two study sites, who will consume assigned product according to instructions for 10 weeks. Three site visits will be made for each participant and all relevant clinical data will be captured and recorded into CTMS(Clinical Trial Management System) for statistical analysis.

Researchers will compare the three groups to conclude whether the Wonderlab study product can improve obesity and overweight over placebo product.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change of Weight
timeFrame: baseline day 0, day 70
Secondary outcomes:
measure: Blood lipids - Total Cholesterol Level
timeFrame: baseline day 0, day 35, day 70
measure: Blood Sugar Level
timeFrame: baseline day 0, day 35, day 70
measure: Blood hormone - Leptin level
timeFrame: baseline day 0, day 35, day 70
measure: Blood hormone - Adiponectin level
timeFrame: baseline day 0, day 35, day 70
measure: Blood inflammation
timeFrame: baseline day 0, day 35, day 70
Other outcomes:
Locations:
city: Shanghai
country: China
facility: SPRIM Central Lab
state: Shanghai
city: Jinhua
country: China
facility: Ligang Hospital
state: Zhejiang
Study officials:
affiliation: Shanghai Fudan University, School of Public Health
name: Hongwei Guo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Jiao Tong University School of Medicine
name: Weixing Wang, MD
role: PRINCIPAL_INVESTIGATOR
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