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Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | Live bacteria strain in a form of a capsule daily for 16 weeks |
|
| Postbiotic | Active Comparator | Heat treated bacteria strain in a form of a capsule daily for 16 weeks |
|
| Placebo | Placebo Comparator | Placebo in a form of a capsule administered for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Live bacteria strain in a form of a capsule daily for 16 weeks |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vineetha Vijayakumar, PhD | Contact | 07885966211 | vineetha.vijayakumar@adm.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Ramon Vidal | ADM Biopolis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea St. Vincent's Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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3 arm parallel design
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| Postbiotic |
| Dietary Supplement |
Heat treated bacteria strain in a form of a capsule daily for 16 weeks |
|
| Placebo | Other | Placebo in a form of a capsule given for 16 weeks |
|
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |