Abdominal Obesity, Obesity
Conditions
Brief summary
Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Live bacteria strain in a form of a capsule daily for 16 weeks
DIETARY_SUPPLEMENTPostbiotic
Heat treated bacteria strain in a form of a capsule daily for 16 weeks
OTHERPlacebo
Placebo in a form of a capsule given for 16 weeks
Sponsors
The Archer-Daniels-Midland Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
3 arm parallel design
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visceral fat area | From week 0 to Week 16 | Difference in visceral fat area (cm\^2) measured using CT from week 0 to week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | Week 0, Week 12, Week 16 | Change in waist circumference (cm) at week 0, week 12 and week 16 |
| Change in body fat composition | Week 0, Week 12, Week 16 | Change in body fat composition using dual-energy x-ray absorptiometry (DEXA) at week 0, Week 12, Week 16 |
| Change in peripheral blood cholesterol | Week 0, Week 16 | Change in Cholesterol concentration (mg/dL) (total, HDL, LDL) in peripheral blood from week 0 to week 16 |
| Change in serum insulin concentration | Week 0, Week 16 | Change in serum insulin from week 0 to week 16 |
| Change in body weight | Week 0, Week 12, Week 16 | Body weight (kg) will be assessed at week 0, Week 12, Week 16 |
| Change in plasma leptin levels | Week 0, Week 16 | Change in leptin week 0 to week 16 |
| Dietary survey | Week 0, Week 16 | 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. |
| Microbiome analysis | Week 0, Week 16 | Stool samples will be collected from participants to analyse change in intestinal microbiota community composition by 16SRNA sequencing |
| Mood questionnaire | Week 0, Week 16 | 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. |
| Change in peripheral blood glucose | Week 0, Week 16 | Change in blood glucose from week 0 to week 16 |
Countries
South Korea
Contacts
Primary ContactVineetha Vijayakumar, PhD
Outcome results
None listed