Effects of Synbiotics on Obesity
ConditionObesity
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-60
SponsorLeeuwenhoek Laboratories Co. Ltd.
About this trial
Synbiotics are a combination of probiotics and prebiotics that can promote the survival of probiotics in the gut. Probiotics utilize prebiotics to produce various metabolites beneficial to human health, such as short-chain fatty acids. The purpose of this trial is to evaluate the impact of a synbiotics product developed by Leewenhoek Laboratories Co., Ltd., on human obesity and its related biomarkers. Participants will be randomly assigned to either the experimental group or the control group in a double-blind trial. The intervention involves the experimental group taking the synbiotics product twice daily, two capsules per dose, after meals for six weeks. The control group will take an equal amount of placebo daily. During the trial, participants' body weight will be recorded weekly, and their body weight, waist circumference, hip circumference, body fat composition, and skeletal muscle mass will be measured before and after the intervention. Additionally, fasting blood samples and blood samples collected at 30, 60, 90, and 120 minutes after consuming the nutritional supplements will be analyzed. The study will compare body fat percentage, body weight, BMI, waist circumference, hip circumference, skeletal muscle mass, and obesity-related biomarkers in blood between the experimental and control groups. The trial results will be used to assess the efficacy of the synbiotics product in improving obesity and its related biomarkers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 20-60 years.
Body weight ≥ 50 kg.
Body Mass Index (BMI) ≥ 24.
Body fat percentage ≥ 30% for females or ≥ 25% for males.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Other interventionPlacebo is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.
Synbiotics
Other interventionSynbiotics is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: ControlPlacebo comparator 1 intervention
Group B: SynbioticsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Body fat percentage
The difference in body fat percentage between experimental group and control group.
Time frame
Up to six weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: