Hospital San Cecilio
Granada, Andalusia, 18016, Spain
NCT Number: NCT04029818
The aim of the present study is to evaluate the ability of Bifidobacterium BSL_PS404 in reducing LDL-cholesterol levels in healthy individuals.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Granada, Andalusia, 18016, Spain
There is a strong correlation between LDL-cholesterol and cardiovascular diseases.
Conjugated bile acids help to break down and emulsify dietary fat into micelles that promote their absorption by the enterocytes. The disruption or alteration of these micelles may interfere with the absorption of cholesterol.
Several intestinal bacteria strains are capable of carrying out numerous biotransformations of bile salts during their enterohepatic circulation, such as the hydrolysis of the conjugated bile acids by the action of hydrolases. The mechanism proposed to explain the cholesterol-lowering activity of these probiotic strains is that, due to the greater bile salt hydroxylation in the intestine, the formation of micelles would decrease and, therefore, the absorption of cholesterol and lipids would be decrease too. In addition, probiotics may also increase the excretion of bile acids in the stool, possibly by binding or absorbing them. This increase in fecal secretion of bile acids would require an increase in the hepatic catabolism of cholesterol for the synthesis of bile acids. All these processes may help to reduce LDL-cholesterol levels Bifidobacterium BSL_PS404 is a bacterium isolated from maternal milk with QPS category that presents a high hydrolase activity that exceeds in more than 20% the activity of other reference strains.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each participant will consume 1 capsule daily at lunch for 8 weeks.
Each participant will consume 1 capsule daily at lunch for 8 weeks.
Time frame: 8 weeks
Levels of LDL-cholesterol in plasma
Time frame: 8 weeks
Levels of total cholesterol in plasma
Time frame: 8 weeks
Levels of HDL-cholesterol in plasma
Time frame: 8 weeks
Levels of triglycerides in plasma
Time frame: 8 weeks
Levels of glucose in plasma
Time frame: 8 weeks
Systolic and diastolic pressure
Time frame: 8 weeks
A person's weight in kilograms (kg) divided by his or her height in meters squared
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Preliminary Study to Evaluate the Effect of the Consumption of Bifidobacterium BSL_PS404 on LDL-cholesterol Levels in Healthy Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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