Effects of Synbiotics on Obesity

Effects of Synbiotics on Obesity and Obesity-related Parameters

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Placebo; Other: Synbiotics

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chiwo-Wei Lin, PhD; Phone Number: #201 +886-2-2377-2318; Email: cwlin@lwhklab.com.tw
• Study Contact Backup: Name: Chi-Shan Li, PhD; Phone Number: #201 +886-2-2377-2318; Email: chishan.li@lwhklab.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Other: Placebo; Placebo 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.
Experimental: Synbiotics	Other: Synbiotics; Synbiotics 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat percentage	The difference in body fat percentage between experimental group and control group.	Up to six weeks

Collaborators and Investigators

• Sponsor: Leeuwenhoek Laboratories Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: LL-IRB-2402

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No