Clinical trial NCT04701775: Effect of Different Probiotic Strains in Hypercholesterolemic Patients
Official title: A Randomized Double-Blind Controlled Trial of Lactobacillus Acidophilus Plus Bifidobacterium Animalis Subsp.Lactis, Versus Lactobacillus Rhamnosus GG Versus Placebo in Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Keywords: serum lipids
hyperlipidemia
probiotics
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Regular probiotic use for 8 weeks was evaluated in individual with mild to moderate hyperlipidemia. Current study have been determined the use of different probiotics strains on lipid parameters such as; total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride levels as well as glycemic parameters such as; glucose, insulin, HOMA-IR levels. Also, hs-CRP levels were investigated as inflammatory parameter.

Detailed description: In the light of recent studies, it has been shown that probiotics may have positive effects on hyperlipidemia. The aim of this study was to investigate the effect of probiotics mainly on blood lipids as well as homocysteine levels, glycemic control parameters and hs-CRP levels A randomized, double-blind placebo-controlled study was completed with a total of 51 individuals who have diagnosed with hyperlipidemia. Participants were randomly assigned into 3 groups according to the probiotic type they would consume, groups were as follows; Lactobacillus (probiotic group I) (n=18), Lactobacillus and Bifidobacterium (probiotic group II) (n=17) and placebo group (n= 16). They were all requested to have placebo or probiotic capsules every day for 8 weeks. Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride levels were investigated as lipid metabolism parameters while fasting blood glucose, insulin, HOMA-IR levels were investigated as glycemic parameters. Also, hs-CRP levels were investigated as inflammatory parameter.

Eligibility criteria: Inclusion Criteria:

• Had a repeated total cholesterol level ≥200 mg/dL prior to allocate to the study group and to declined conventional lipid lowering medical treatment

Exclusion Criteria:

* Those with any chronic conditions other than hypercholesterolemia,
* Individuals with inherited lipid metabolic disorders,
* Individuals with chronic gastrointestinal disease,
* Individuals with immunodeficiency,
* Individuals with malignancy,
* Individuals with mental disabilities,
* Patients currently using any lipid lowering drugs, or an alternative treatment to lower blood cholesterol (such as probiotics) and individuals who have used antibiotics in the previous three months prior to study and
* Pregnant or lactating women were excluded from the study.

Primary outcomes:
measure: Change from baseline in total cholesterol level with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in Low Density Lipoprotein (LDL) levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in Triglyceride levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in fasting glucose levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in fasting insulin levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change from baseline in total cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in LDL cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in triglyceride level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in fasting glucose level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in fasting insulin with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
timeFrame: Baseline and Week 8
Other outcomes:
measure: Change from baseline in total cholesterol level with the use of placebo at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in LDL cholesterol level with the use of placebo at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in triglyceride level with the use of placebo at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in fasting glucose level with the use of placebo at week 8
timeFrame: Baseline and Week 8
measure: Change from baseline in fasting insulin level with the use of placebo at week 8
timeFrame: Baseline and Week 8
Locations:
city: Famagusta
country: Cyprus
facility: Gözde Okburan
Study officials:
affiliation: Eastern Medittanean University
name: Gözde Okburan
role: PRINCIPAL_INVESTIGATOR
References: