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The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

Primary Purpose

Overweight

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Study product A (Wonderlab wonder4shape)
Study product B (Wonderlab wonder4shape)
Study product C (Wonderlab wonder4shape)
Study product D
Sponsored by
Shenzhen Precision Health Food Technology Co. Ltd.,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight focused on measuring Probiotics, Prebiotics, Overweight

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ai'er Hospital
  • SPRIM Central Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Study product A (Wonderlab wonder4shape)

Study product B (Wonderlab wonder4shape)

Study product C (Wonderlab wonder4shape)

Study product D

Arm Description

2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU: CECT7527, CECT7528, CECT7529, B420, HN019 FOS Polydextrose IMO

2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU: B420, HN019, NCFM FOS Polydextrose IMO

2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU: CECT7527, CECT7528, CECT7529, B420, HN019 XOS Polydextrose IMO

2g/bottle: MD Cucumber powder

Outcomes

Primary Outcome Measures

Change of Weight
Change of Weight in Kg by Inbody S10 from baseline to 2 months

Secondary Outcome Measures

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
Blood Sugar Level
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
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
Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL for each visit interval
Blood inflammation
Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4) for each visit interval
Feces SCFA
Feces SCFA for each visit interval
Feces sIgA
Feces sIgA for each visit interval
Liver function test
Liver function test for each visit interval

Full Information

First Posted
January 5, 2023
Last Updated
April 26, 2023
Sponsor
Shenzhen Precision Health Food Technology Co. Ltd.,
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1. Study Identification

Unique Protocol Identification Number
NCT05710055
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 4, 2023 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Precision Health Food Technology Co. Ltd.,

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Probiotics, Prebiotics, Overweight

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study product A (Wonderlab wonder4shape)
Arm Type
Active Comparator
Arm Description
2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU: CECT7527, CECT7528, CECT7529, B420, HN019 FOS Polydextrose IMO
Arm Title
Study product B (Wonderlab wonder4shape)
Arm Type
Active Comparator
Arm Description
2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU: B420, HN019, NCFM FOS Polydextrose IMO
Arm Title
Study product C (Wonderlab wonder4shape)
Arm Type
Active Comparator
Arm Description
2g/bottle, containing the following probiotics total dosage 2.0*10^10 CFU: CECT7527, CECT7528, CECT7529, B420, HN019 XOS Polydextrose IMO
Arm Title
Study product D
Arm Type
Placebo Comparator
Arm Description
2g/bottle: MD Cucumber powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Study product A (Wonderlab wonder4shape)
Intervention Description
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Study product B (Wonderlab wonder4shape)
Intervention Description
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Study product C (Wonderlab wonder4shape)
Intervention Description
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Study product D
Intervention Description
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Primary Outcome Measure Information:
Title
Change of Weight
Description
Change of Weight in Kg by Inbody S10 from baseline to 2 months
Time Frame
baseline day 0, day 60
Secondary Outcome Measure Information:
Title
Blood lipids - Total Cholesterol Level
Description
Blood lipids - Total Cholesterol level of blood test in mmol/L and range of 0.56-17mmol/L for each visit interval
Time Frame
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Title
Blood Sugar Level
Description
Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L for each visit interval
Time Frame
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Title
Blood Hormone - Leptin Level
Description
Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL for each visit interval
Time Frame
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Title
Blood Hormone - Adiponectin Level
Description
Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL for each visit interval
Time Frame
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Title
Blood inflammation
Description
Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4) for each visit interval
Time Frame
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Title
Feces SCFA
Description
Feces SCFA for each visit interval
Time Frame
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Title
Feces sIgA
Description
Feces sIgA for each visit interval
Time Frame
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Title
Liver function test
Description
Liver function test for each visit interval
Time Frame
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weixing Wang, MD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ai'er Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
SPRIM Central Lab
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

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