Obese, Weight, Body
Conditions
Keywords
probiotic, Obese, Colonization, Microbiota
Brief summary
The goal of this interventional study is to test the colonization of a new generation probiotic in normal weight and overweight/obese people. The main question aims to answer is if our bacteria is able to colonize the human intestine. Participants will recieve a probiotic pill every day during 15 consecutive days and fill in questionaries.
Detailed description
Normal weight and overweight volunteers will be recruited to evaluate the colonization capacity of the bacteria. In this case, stool samples will be taken before starting the intervention (T0), after the treatment (T1) and a week after fiinishing the administration of the probiotic (T2). All the subjects will receive the probiotic supplement in capsules taken daily, 7-8 normal weight subjects will take a concentration of 10\^9-10 CFU and 7-8 overweight subjects will take a concentration of 10\^9-10 CFU.
Interventions
DIETARY_SUPPLEMENTProbiotic
Resistant gastrointestinal capsules will be provided daily to the participants.
Sponsors
Valencian Innovation Agency
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Samples will be coded and they will not know the pacient personal/sociodemographic data.
Intervention model description
We will try the probiotic in normal weight and overweight/obese people
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 65 years. * Body mass index between 20-25 kg/m2 for normopese subjects and BMI 25-30 kg/m2 for overweight participants. * Body weight and eating habits stable in the last three months before the first visit. * Willingness to participate in the intervention study, giving their data and samples. * Signature and acceptance of the informed consent.
Exclusion criteria
* Preexistence of other physical conditions (food allergy/sensitivity, gastrointestinal conditions \[such as inflammatory bowel disease, celiac disease, pancreatitis, chronic constipation, etc.\], immunodeficiency) * Eating disorders * Use of antibiotics one month prior to the first visit * Chronic use of medications (antacids, antidiabetics, anti-hypertensives, etc.) * History or current abuse of drugs or alcohol * Following a vegetarian, vegan, or other restrictive diet * Any other reason deemed appropriate for exclusion at the clinician's discretion * Non-compliance with adherence to treatment regimen * Direct association with research and/or investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of our bacteria in feces | Before the end of 2023 | By specific PCR or by 16s sequencing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effect | Before the end of 2023 | Check if the probiotic is well tolerated. We will collect gastrointestinal symptoms and bristol scale. |
Countries
Spain
Outcome results
None listed