NCT06030999Completed
The Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics
Three Arms, Randomized, Double-blind Controlled Trial Of Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics
Source: ClinicalTrials.gov · Last updated 21 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 3 Sept 2023
- Start date
- 18 Sept 2023
- Primary completion date
- 2 Dec 2023
- Lead sponsor
- Shenzhen Precision Health Food Technology Co. Ltd.,
- Diseases
- Obesity
- NCT number
- NCT06030999
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From 18 Sept 2023 to the primary completion date, 2 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have used any medication for weight management at least one month before this study.
- Subject having done plastic surgery for weight management.
- Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
- 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.
Other illness
- 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.
- 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.
Other
- Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
- Have any cuts/abrasions on the test site at baseline.
- The subject is an employee of sponsor or the site conducting the study.
Who the study is looking for
- 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.
Age in the registry: 25 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ligang Hospital Coordinator of this site? Confirm its status | Jinhua | China | Unknown status |
| SPRIM Central Lab Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.