The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

Shenzhen Precision Health Food Technology

Status: Completed

Conditions: Overweight

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05710055

22-SM-12-WL-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 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;
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 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\*10\^10 CFU: * CECT7527, CECT7528, CECT7529, B420, HN019 * FOS * Polydextrose * IMO

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 2.0\*10\^10 CFU: * B420, HN019, NCFM * FOS * Polydextrose * IMO

Treatment:

Dietary Supplement: Study product B (Wonderlab wonder4shape)

Study product C (Wonderlab wonder4shape)

Active Comparator group

Description:

2g/bottle, containing the following probiotics total dosage 2.0\*10\^10 CFU: * CECT7527, CECT7528, CECT7529, B420, HN019 * XOS * Polydextrose * IMO

Treatment:

Dietary Supplement: Study product C (Wonderlab wonder4shape)

Study product D

Placebo Comparator group

Description:

2g/bottle: * MD * Cucumber powder

Treatment:

Dietary Supplement: Study product D