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

Shenzhen Precision Health Food Technology

Status: Completed

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: Study product B (Wonderlab wonder4shape); Dietary Supplement: Study product C (placebo); Dietary Supplement: Study product A (Wonderlab wonder4shape)

Study type: Interventional

Funder types: Other

Identifiers

NCT06030999

23-SM-08-WL-001

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

Study product A (Wonderlab wonder4shape)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Study product A (Wonderlab wonder4shape)

Study product B (Wonderlab wonder4shape)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Study product B (Wonderlab wonder4shape)

Study product C (placebo)

Placebo Comparator group

Description:

2g/bottle, containing the following ingredients: * Maltodextrin * Grapefruit powder * Lemon powder

Treatment:

Dietary Supplement: Study product C (placebo)