The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-blind, Controlled Trial to Evaluate the Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

Conditions
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Overweight

Intervention / Treatment
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* Dietary Supplement: Study product A (Wonderlab wonder4shape)
* Dietary Supplement: Study product B (Wonderlab wonder4shape)
* Dietary Supplement: Study product C (Wonderlab wonder4shape)
* Dietary Supplement: Study product D


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study product A (Wonderlab wonder4shape)<br>2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU: CECT7527, CECT7528, CECT7529, B420, HN019 FOS Polydextrose IMO | Dietary Supplement: Study product A (Wonderlab wonder4shape)<br>* Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months<br>|
| Active Comparator: Study product B (Wonderlab wonder4shape)<br>2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU: B420, HN019, NCFM FOS Polydextrose IMO | Dietary Supplement: Study product B (Wonderlab wonder4shape)<br>* Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months<br>|
| Active Comparator: Study product C (Wonderlab wonder4shape)<br>2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU: CECT7527, CECT7528, CECT7529, B420, HN019 XOS Polydextrose IMO | Dietary Supplement: Study product C (Wonderlab wonder4shape)<br>* Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months<br>|
| Placebo Comparator: Study product D<br>2g/bottle: MD Cucumber powder | Dietary Supplement: Study product D<br>* Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Weight | Change of Weight in Kg by Inbody S10 from baseline to 2 months | baseline day 0, day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipids - Total Cholesterol Level | Blood lipids - Total Cholesterol level of blood test in mmol/L and range of 0.56-17mmol/L for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | 
| Blood Sugar Level | Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | 
| Blood Hormone - Leptin Level | Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | 
| Blood Hormone - Adiponectin Level | Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | 
| Blood inflammation | Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4) for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | 
| Feces SCFA | Feces SCFA for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | 
| Feces sIgA | Feces sIgA for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | 
| Liver function test | Liver function test for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Prebiotics, Overweight