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

February 19, 2024 updated by: Shenzhen Precision Health Food Technology Co. Ltd.,

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • SPRIM Central Lab
    • Zhejiang
      • Jinhua, Zhejiang, China
        • Ligang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 > 5mmol/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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study product A (Wonderlab wonder4shape)

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)
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks
Active Comparator: Study product B (Wonderlab wonder4shape)

2g/bottle, containing the following probiotics total dosage 1.0*1010 CFU:

  • Maltodextrin
  • Lactobacillus acidophilus
Dietary supplement: Study product B (Wonderlab wonder4shape)
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks
Placebo Comparator: Study product C (placebo)

2g/bottle, containing the following ingredients:

  • Maltodextrin
  • Grapefruit powder
  • Lemon powder
Dietary supplement: Study product C (placebo)
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Weight
Time Frame: baseline day 0, day 70
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
Time Frame: baseline day 0, day 35, day 70
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
Time Frame: baseline day 0, day 35, day 70
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
Time Frame: baseline day 0, day 35, day 70
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
Time Frame: baseline day 0, day 35, day 70
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
Time Frame: baseline day 0, day 35, day 70
Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4)
baseline day 0, day 35, day 70

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Precision Health Food Technology Co. Ltd.,

Investigators

  • Principal Investigator: Weixing Wang, MD, Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: Hongwei Guo, MD, Shanghai Fudan University, School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

December 2, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

September 3, 2023

First Submitted That Met QC Criteria

September 3, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-SM-08-WL-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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