The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

Sponsor

Shenzhen Precision Health Food Technology Co. Ltd., (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05710055

Collaborator

(none)

200

Enrollment

Locations

Arms

3.9

Anticipated Duration (Months)

100

Patients Per Site

25.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight	Dietary Supplement: Study product A (Wonderlab wonder4shape) Dietary Supplement: Study product B (Wonderlab wonder4shape) Dietary Supplement: Study product C (Wonderlab wonder4shape) Dietary Supplement: Study product D	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change of Weight [baseline day 0, day 60]
Change of Weight in Kg by Inbody S10 from baseline to 2 months

Secondary Outcome Measures

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
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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ai'er Hospital	Shanghai	Shanghai	China
2	SPRIM Central Lab	Shanghai	Shanghai	China

Sponsors and Collaborators

Shenzhen Precision Health Food Technology Co. Ltd.,

Investigators

Principal Investigator: Weixing Wang, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Shenzhen Precision Health Food Technology Co. Ltd.,

ClinicalTrials.gov Identifier:

NCT05710055

Other Study ID Numbers:

22-SM-12-WL-001

First Posted:

Feb 2, 2023

Last Update Posted:

Feb 2, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shenzhen Precision Health Food Technology Co. Ltd.,

Probiotics

Prebiotics

Overweight

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Feb 2, 2023