Overweight
Conditions
Keywords
Probiotics, Prebiotics, Overweight
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.
Interventions
DIETARY_SUPPLEMENTStudy product A (Wonderlab wonder4shape)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
DIETARY_SUPPLEMENTStudy product B (Wonderlab wonder4shape)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
DIETARY_SUPPLEMENTStudy product C (Wonderlab wonder4shape)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
DIETARY_SUPPLEMENTStudy product D
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Sponsors
Shenzhen Precision Health Food Technology Co. Ltd.,
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Weight | baseline day 0, day 60 | Change of Weight in Kg by Inbody S10 from baseline to 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Sugar Level | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L for each visit interval |
| Blood Hormone - Leptin Level | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL for each visit interval |
| Blood Hormone - Adiponectin Level | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL for each visit interval |
| Blood lipids - Total Cholesterol Level | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | Blood lipids - Total Cholesterol level of blood test in mmol/L and range of 0.56-17mmol/L for each visit interval |
| Feces SCFA | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | Feces SCFA for each visit interval |
| Feces sIgA | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | Feces sIgA for each visit interval |
| Liver function test | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | Liver function test for each visit interval |
| Blood inflammation | baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90 | Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4) for each visit interval |
Countries
China
Outcome results
None listed