Clinical trial NCT06578143: Effects of Synbiotics on Obesity
Official title: Effects of Synbiotics on Obesity and Obesity-related Parameters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Leeuwenhoek Laboratories Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Primary outcomes:
measure: Body fat percentage
timeFrame: Up to six weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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