Clinical trial NCT05710055: The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics
Official title: A Randomized, Double-blind, Controlled Trial to Evaluate the Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Probiotics
Prebiotics
Overweight
Lead sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,
Sponsor class: OTHER_GOV
First posted: 2023-02-02
Enrollment: 200
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 evaluate the efficacy of probiotics with prebiotics on overweight.

200 eligible participants with overweight will be enrolled and randomized to consume four study products for 3 months.

Reseachers will compare the four groups to evaluate whether there is significant improvement on overweight for participants in the study product of probiotics with prebiotics.

Detailed description: This study is a multi-center, four arms, randomized, double-blind controlled trial. 200 Eligible participants of 25 to 45 years old with overweight will be randomized in four equal size groups to receive one of the four products of probiotics with and without prebiotics and consume one bottle once in a day for 3 months. All participants will visit the study site for 3 times, once a month, all relevant clinical data will be captured, and recorded in to CTMS (Clinical Trial Management System). Data will be analyzed and reported after the completion of the study.

Eligibility criteria: Inclusion Criteria:

* Chinese males or females, age between 25-45;
* Overweight population: BMI 24-27.9;
* Blood lipids in high potential risks but without medication; TG \> 5mol/L, LDL \>= 3.4 mmol/L, 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 enrollment.
* 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 60
Secondary outcomes:
measure: Blood lipids - Total Cholesterol Level
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
measure: Blood Sugar Level
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
measure: Blood Hormone - Leptin Level
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
measure: Blood Hormone - Adiponectin Level
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
measure: Blood inflammation
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
measure: Feces SCFA
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
measure: Feces sIgA
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
measure: Liver function test
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ai'er Hospital
state: Shanghai
city: Shanghai
country: China
facility: SPRIM Central Lab
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Weixing Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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