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NCT05878444 | Not yet recruiting | Obese

Evaluation of the Colonization Capacity of a Probiotic Bacterium.
Sponsor:

Valencian Innovation Agency

Information provided by (Responsible Party):

Yolanda Sanz Herranz

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.

Condition or disease

Obese

Weight, Body

Intervention/treatment

Probiotic

Phase

Phase 1

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.}}

Study Type : Interventional
Estimated Enrollment : 15 participants
Masking : Single
Masking Description : Samples will be coded and they will not know the pacient personal/sociodemographic data.
Primary Purpose : Treatment
Official Title : Evaluate the Colonization Capacity of a New Generation Probiotic Within the Project: Valorization of an Intestinal Bacterium as a Functional Ingredient to Prevent the Development of Metabolic Syndrome and Diabetes -BIOPRED
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : January 31, 2024
Arm Intervention/treatment

Experimental: Normal weight

People with BMI between 20-25 will be enrolled in this group. They will take the probiotic capsule daily during 15 days. Dosis will be 10^9-10.

Dietary Supplement: Probiotic

Experimental: Overweight/Obese

People with BMI >25 will be enrolled in this group. They will take the probiotic capsule daily during 15 days. Dosis will be 10^9-10.

Dietary Supplement: Probiotic
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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
Evaluation of the Colonization Capacity of a Probiotic Bacterium.

Location Details

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Evaluation of the Colonization Capacity of a Probiotic Bacterium.

How to Participate

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Locations

Not yet recruiting

Spain, Valencia

Institute of Agrochemistry and Food Technology

Paternal, Valencia, Spain, 46980