The Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics

Study Overview
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Brief Summary
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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.

Official Title
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Three Arms, Randomized, Double-blind Controlled Trial Of Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics

Conditions
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Overweight and Obesity

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 (placebo)


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 & obesity population: BMI >=28; Blood lipids in high potential risks but without medication:TG > 5mol/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.

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*1010 CFU: CECT7527, CECT7528, CECT7529 Maltodextrin Lactobacillus acidophilus Fructose oligosaccharides Grapefruit, Lemon and Apple powder | Dietary Supplement: Study product A (Wonderlab wonder4shape)<br>* Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks<br>|
| Active Comparator: Study product B (Wonderlab wonder4shape)<br>2g/bottle, containing the following probiotics total dosage 1.0*1010 CFU: Maltodextrin Lactobacillus acidophilus | Dietary Supplement: Study product B (Wonderlab wonder4shape)<br>* Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks<br>|
| Placebo Comparator: Study product C (placebo)<br>2g/bottle, containing the following ingredients: Maltodextrin Grapefruit powder Lemon powder | Dietary Supplement: Study product C (placebo)<br>* Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks<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 10 weeks | baseline day 0, day 70 | 

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, day 35, day 70 | 
| Blood Sugar Level | Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L | baseline day 0, day 35, day 70 | 
| Blood hormone - Leptin level | Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL | baseline day 0, day 35, day 70 | 
| Blood hormone - Adiponectin level | Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL | baseline day 0, day 35, day 70 | 
| Blood inflammation | Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4) | baseline day 0, day 35, day 70 | 

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