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Not Yet Recruiting NCT05710055

The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

Conditions: Overweight

Sex: All
Ages: 25 Years – 45 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 200
Sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,

Location: China

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05710055). StuddyBuddy aggregates publicly available trial information.