Investigating a probiotic and postbiotic for overweight individuals
Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Live and Heat Treated Bacteria Strain on Body Composition in Overweight Individuals
This study is testing whether a probiotic and a postbiotic can help overweight adults lose weight and improve their body composition compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | The Archer-Daniels-Midland Company Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05428137 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and efficacy of a probiotic and a postbiotic in overweight individuals with a body mass index (BMI) between 25 and 33 kg/m2 and abdominal obesity. Participants will receive either the probiotic, postbiotic, or a placebo to assess changes in body composition. The trial will be conducted at a single research center, focusing on adult men and women who meet specific inclusion criteria. The study will monitor participants for any adverse effects and measure the effectiveness of the interventions over the trial period.
Who should consider this trial
Good fit: Ideal candidates for this study are overweight adults with a BMI of 25-33 kg/m2 and abdominal obesity.
Not a fit: Patients with secondary obesity, diabetes, gastrointestinal diseases, or those taking certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary intervention for managing obesity and improving body composition in overweight individuals.
How similar studies have performed: Other studies have shown promising results with probiotics and postbiotics in managing obesity, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body mass index 25-33kg/m2 * Abdominal obesity (female waist circumference\>85cm; male waist circumference\>90cm) * written informed consent Exclusion Criteria: * Taking the following medication within 1 month before starting the study: appetite stimulants/suppressants, lipid lowering drug, contraceptive * taking antibiotics within 2 months before starting the study * secondary obesity or secondary hypertension, diabetes type 1, GI disease, dyslipidaemia, type 2diabetes, hypertension * consumption of pre- and probiotic-enriched products or dietary supplement for at least 4 weeks prior to the first screening visit * nicotine, drug or alcohol abuse, * other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit or confound the Study's results
Where this trial is running
Seoul
- The Catholic University of Korea St. Vincent's Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Vineetha Vijayakumar, PhD
- Email: vineetha.vijayakumar@adm.com
- Phone: 07885966211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.