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

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: Study product A (Wonderlab wonder4shape); Dietary Supplement: Study product C (placebo); Dietary Supplement: Study product B (Wonderlab wonder4shape)

• Registration Number: NCT06030999
• Lead Sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-03
• Study First Submitted QC: 2023-09-03
• Study First Posted: 2023-09-11
• Study Start: 2023-09-18
• Primary Completion: 2023-12-02
• Study Completion: 2023-12-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study product A (Wonderlab wonder4shape)	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
Study product C (placebo)	Study product C (placebo)	2g/bottle, containing the following ingredients: * Maltodextrin * Grapefruit powder * Lemon powder
Study product B (Wonderlab wonder4shape)	Study product B (Wonderlab wonder4shape)	2g/bottle, containing the following probiotics total dosage 1.0\*1010 CFU: * Maltodextrin * Lactobacillus acidophilus

Primary Outcome Measures

Name	Time	Method
Change of Weight	baseline day 0, day 70	Change of Weight in Kg by Inbody S10 from baseline to 10 weeks

Secondary Outcome Measures

Name	Time	Method
Blood hormone - Leptin level	baseline day 0, day 35, day 70	Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL
Blood lipids - Total Cholesterol Level	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
Blood Sugar Level	baseline day 0, day 35, day 70	Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L
Blood inflammation	baseline day 0, day 35, day 70	Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4)
Blood hormone - Adiponectin level	baseline day 0, day 35, day 70	Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL

Trial Locations

Locations (2)

Ligang Hospital; 🇨🇳 Jinhua, Zhejiang, China

SPRIM Central Lab; 🇨🇳 Shanghai, Shanghai, China