Status:
COMPLETED
Probiotic Intervention, Bile Acids and Lipid Metabolism Metabolic Profile in Healthy Overweight Subjects.
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsors:
AB Biotics, SA
Conditions:
Probiotic Intervention
Eligibility:
All Genders
25-60 years
Phase:
NA
Brief Summary
Moderate hypercholesterolemia, metabolic alterations derived from overweight or obesity, and consequently and their related cardiovascular risks can be reduced through changes in lifestyle. A growing ...
Detailed Description
Sample size (N=20) was calculated according results of previous studies on plasma bile acids. The study refers to healthy overweight \[body mass index (BMI) 25.0-29.9 kg/m2\] adult men (N=10) and wome...
Eligibility Criteria
Inclusion
- Body Mass index (BMI): Between 25 and 30 Kg / m2
Exclusion
- Eating disorders.
- Subjects with cardiovascular risk factors such as hypercholesterolemia (genetic or secondary), hypertension and diabetes, treated pharmacologically.
- History of ischemic heart disease (and / or previous angina or AMI) or arrhythmia (current or previous).
- Previous strokes and / or peripheral vascular disease.
- Alcohol consumption greater than 60 gr / day.
- Kidney failure (creatinine\> 2 mg / dl).
- Presence of neoplasia.
- Presence of systemic disease.
- Psychiatric illness under treatment with psychotropics.
- Unstabilized thyroid disease.
- Having followed or being following a hypocaloric diet or regularly consumed dietary supplements for weight or constipation or cholesterol control (plant sterols, soy lecithin, omega-3 fatty acids) for 2 months prior to inclusion in the study.
- Pregnancy or breastfeeding.
- In current treatment with non-steroidal anti-inflammatory drugs, antiplatelet agents, fibrates or statins.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05378230
Start Date
September 1 2020
End Date
February 21 2022
Last Update
June 7 2022
Active Locations (1)
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1
Institut Recerca-Hospital Santa Creu I Sant Pau
Barcelona, Spain, 08025