CClinicalTrials.gg
Not yet recruitingNCT06578143Updated Oct 9, 2024

Effects of Synbiotics on Obesity

A Phase 2 interventional study of Placebo and Synbiotics in Obesity, sponsored by Leeuwenhoek Laboratories Co. Ltd.. Not yet recruiting. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by Leeuwenhoek Laboratories Co. Ltd. · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

Browse trials for

03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 80 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Leeuwenhoek Laboratories Co. Ltd. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Placebo comparator
    Control

    Other: Placebo

  • Experimental
    Synbiotics

    Other: Synbiotics

Interventions

  • OtherPlacebo

    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.

  • OtherSynbiotics

    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.

06

What researchers measure

Primary outcomes

  1. Body fat percentage

    The difference in body fat percentage between experimental group and control group.

    Time frame: Up to six weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06578143
Lead sponsor
Leeuwenhoek Laboratories Co. Ltd.
Responsible party
Sponsor
First posted
Aug 29, 2024
Start date
Oct 15, 2024 (estimated)
Primary completion
Dec 1, 2024 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Oct 9, 2024

Study contacts

Chiwo-Wei Lin, PhD
Contact
cwlin@lwhklab.com.tw
+886-2-2377-2318 ext. #201
Chi-Shan Li, PhD
Contact
chishan.li@lwhklab.com.tw
+886-2-2377-2318 ext. #201

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion