The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

April 26, 2023 updated by: Shenzhen Precision Health Food Technology Co. Ltd.,

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

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
        • Ai'er Hospital
      • Shanghai, Shanghai, China
        • SPRIM Central Lab

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

25 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

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*10^10 CFU:

  • CECT7527, CECT7528, CECT7529, B420, HN019
  • FOS
  • Polydextrose
  • IMO
Dietary supplement: Study product A (Wonderlab wonder4shape)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Active Comparator: Study product B (Wonderlab wonder4shape)

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)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Active Comparator: Study product C (Wonderlab wonder4shape)

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)
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Placebo Comparator: Study product D

2g/bottle:

  • MD
  • Cucumber powder
Dietary supplement: Study product D
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Weight
Time Frame: baseline day 0, day 60
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
Time Frame: 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
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood Sugar Level
Time Frame: 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
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood Hormone - Leptin Level
Time Frame: 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
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood Hormone - Adiponectin Level
Time Frame: 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
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood inflammation
Time Frame: 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
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Feces SCFA
Time Frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Feces SCFA for each visit interval
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Feces sIgA
Time Frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Feces sIgA for each visit interval
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Liver function test
Time Frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Liver function test for each visit interval
baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90

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

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)

February 4, 2023

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-SM-12-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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