Trials / Completed
CompletedNCT04701775
Effect of Different Probiotic Strains in Hypercholesterolemic Patients
A Randomized Double-Blind Controlled Trial of Lactobacillus Acidophilus Plus Bifidobacterium Animalis Subsp.Lactis, Versus Lactobacillus Rhamnosus GG Versus Placebo in Patients With Hypercholesterolemia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Eastern Mediterranean University · Academic / Other
- Sex
- All
- Age
- 19 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Only Lactobacillus rhamnosus GG strains | 1x106 colony forming unit (CFU) Lactobacillus rhamnosus GG probiotic capsule |
| COMBINATION_PRODUCT | Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains | combination of Lactobacillus acidophilus 1x109 CFU and Bifidobacterium animalis subsp.lactis 1x109 CFU probiotic capsule |
| OTHER | Placebo | Placebo probiotic capsule |
Timeline
- Start date
- 2018-09-28
- Primary completion
- 2019-02-01
- Completion
- 2019-03-07
- First posted
- 2021-01-08
- Last updated
- 2021-01-12
Locations
1 site across 1 country: Cyprus
Source: ClinicalTrials.gov record NCT04701775. Inclusion in this directory is not an endorsement.