Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals

Study Overview
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Brief Summary
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Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.

Detailed Description
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This study aims to investigate the safety and efficacy of live and heat treated bacteria on body composition of overweight individuals. The trial will be run in a single research centre and will recruit adult men and women, with BMI of 25-33kg/m2 with abdominal obesity.

Official Title
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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

Conditions
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Obesity, Abdominal Obesity

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Postbiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 arm parallel design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>Live bacteria strain in a form of a capsule daily for 16 weeks | Dietary Supplement: Probiotic<br>* Live bacteria strain in a form of a capsule daily for 16 weeks<br>|
| Active Comparator: Postbiotic<br>Heat treated bacteria strain in a form of a capsule daily for 16 weeks | Dietary Supplement: Postbiotic<br>* Heat treated bacteria strain in a form of a capsule daily for 16 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo in a form of a capsule administered for 16 weeks | Other: Placebo<br>* Placebo in a form of a capsule given for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visceral fat area | Difference in visceral fat area (cm^2) measured using CT from week 0 to week 16 | From week 0 to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Body weight (kg) will be assessed at week 0, Week 12, Week 16 | Week 0, Week 12, Week 16 | 
| Change in waist circumference | Change in waist circumference (cm) at week 0, week 12 and week 16 | Week 0, Week 12, Week 16 | 
| Change in body fat composition | Change in body fat composition using dual-energy x-ray absorptiometry (DEXA) at week 0, Week 12, Week 16 | Week 0, Week 12, Week 16 | 
| Change in peripheral blood cholesterol | Change in Cholesterol concentration (mg/dL) (total, HDL, LDL) in peripheral blood from week 0 to week 16 | Week 0, Week 16 | 
| Change in serum insulin concentration | Change in serum insulin from week 0 to week 16 | Week 0, Week 16 | 
| Change in peripheral blood glucose | Change in blood glucose from week 0 to week 16 | Week 0, Week 16 | 
| Change in plasma leptin levels | Change in leptin week 0 to week 16 | Week 0, Week 16 | 
| Dietary survey | Food cravings will be assessed using the Food Craving Questionnaires (FCQ) at week 0 and week 16. The change in score compared to baseline and between groups will be assessed at the end of the study. | Week 0, Week 16 | 
| Microbiome analysis | Stool samples will be collected from participants to analyse change in intestinal microbiota community composition by 16SRNA sequencing | Week 0, Week 16 | 
| Mood questionnaire | Participants mood will be assessed using the PHQ-9 (Patient Health Questionnaire-9). The change in score compared to baseline and between groups will be assessed at the end of the study. | Week 0, Week 16 |