Effects of Synbiotics on Obesity

Launched by LEEUWENHOEK LABORATORIES CO. LTD. · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a special product called synbiotics on obesity. Synbiotics are a combination of probiotics (good bacteria) and prebiotics (food for those bacteria) that may help improve health by supporting a healthy gut. The goal of the study is to see how this synbiotic product, developed by Leewenhoek Laboratories, can affect weight and related health markers in people who are overweight. Participants will be placed in one of two groups: one group will take the synbiotics twice a day for six weeks, while the other group will take a placebo, which looks the same but has no active ingredients.

To be eligible for the trial, participants need to be between the ages of 20 and 60, weigh at least 50 kg, and have a Body Mass Index (BMI) of 24 or higher. They should also have a certain amount of body fat and waist size based on gender. Participants will be asked to keep track of their weight weekly and follow specific dietary guidelines during the study. Throughout the trial, their weight, waist size, and body fat will be measured, and blood samples will be taken to check health markers related to obesity. This study aims to gather important information that could help improve treatment options for obesity in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 20-60 years.
• • Body weight ≥ 50 kg.
• • Body Mass Index (BMI) ≥ 24.
• • Body fat percentage ≥ 30% for females or ≥ 25% for males.
• • Waist circumference ≥ 80 cm for females or ≥ 90 cm for males.
• • No remarkable medical history within the past six months.
• • Willing to comply with the nutritional instructions during the study period.
• • Willing to report body weight once a week.
• • Willing to report dietary and activity records.
• • Willing to comply with the instruction of "not using" other products containing probiotics or enzymes (excluding yogurt and yogurt drinks).
• • Willing to sign Clinical Trial Informed Consent Form before the trial.
• Exclusion Criteria:
• • Pregnant or breastfeeding.
• • Without statutory notifiable diseases, including HIV, syphilis, hepatitis B, hepatitis C, etc.
• • Judged by a physician to have "secondary obesity" (obesity caused by endocrine disorders or metabolic abnormalities).
• • Presence of endocrine disorders, hypertension, diabetes, cerebrovascular diseases, cardiovascular diseases, liver diseases, kidney diseases, gastrointestinal diseases, or mental disorders.
• • Currently taking medications for lipid-lowering, blood sugar control, or weight loss.
• • Currently taking antibiotic-related medications.
• • Determined unsuitable for participation in this trial by a physician.