An interventional study of Only Lactobacillus rhamnosus GG strains and Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains in Hyperlipidemias, sponsored by Eastern Mediterranean University. Completed at 1 site in Cyprus. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Treatment
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.
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.
839 studies on the registry are indexed under Hyperlipidemias; 107 are open to participants now.
This study's enrollment of 51 is below the median of 88 across 707 interventional studies indexed under Hyperlipidemias.
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Exclusion Criteria:
Participants received only 1x106 cfu Lactobacillus rhamnosus GG once a day for 8 weeks.
Dietary Supplement: Only Lactobacillus rhamnosus GG strains
Participants recevied a combined Lactobacillus acidophilus 1x109 cfu and Bifidobacterium animalis subsp.lactis 1x109 cfu once a day for 8 weeks.
Combination Product: Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains
Those participants received placebo capsule once a day for 8 weeks.
Other: Placebo
1x106 colony forming unit (CFU) Lactobacillus rhamnosus GG probiotic capsule
combination of Lactobacillus acidophilus 1x109 CFU and Bifidobacterium animalis subsp.lactis 1x109 CFU probiotic capsule
Placebo probiotic capsule
Change from baseline in total cholesterol level with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases total cholesterol level. Change = (Baseline total cholesterol-Week 8 total cholesterol)
Time frame: Baseline and Week 8
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
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases LDL cholesterol. Change = (Baseline LDL cholesterol values -Week 8 LDL cholesterol values)
Time frame: Baseline and Week 8
Change from baseline in Triglyceride levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases triglyceride levels. Change = (Baseline triglyceride values -Week 8 triglyceride values)
Time frame: Baseline and Week 8
Change from baseline in fasting glucose levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases fasting blood glucose levels. Change = (Baseline fasting glucose values -Week 8 fasting glucose values)
Time frame: Baseline and Week 8
Change from baseline in fasting insulin levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases fasting insulin levels. Change = (Baseline fasting insulin values -Week 8 fasting insulin values)
Time frame: Baseline and Week 8
Change from baseline in total cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Lactobacillus rhamnosus GG microorganisms decreases total cholesterol level. Change = (Baseline total cholesterol-Week 8 total cholesterol)
Time frame: Baseline and Week 8
Change from baseline in LDL cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Lactobacillus rhamnosus GG microorganisms decreases LDL cholesterol level. Change = (Baseline LDL cholesterol-Week 8 LDL cholesterol)
Time frame: Baseline and Week 8
Change from baseline in triglyceride level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Lactobacillus rhamnosus GG microorganisms decreases triglyceride level. Change = (Baseline triglyceride values-Week 8 trgylceride values)
Time frame: Baseline and Week 8
Change from baseline in fasting glucose level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Lactobacillus rhamnosus GG microorganisms decreases fasting glucosel level. Change = (Baseline fasting glucosel-Week 8 fasting glucose)
Time frame: Baseline and Week 8
Change from baseline in fasting insulin with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Lactobacillus rhamnosus GG microorganisms decreases fasting insulin level. Change = (Baseline fasting insulin-Week 8 fasting insulin)
Time frame: Baseline and Week 8
Change from baseline in total cholesterol level with the use of placebo at week 8
Placebo capsules usually do not improve total cholesterol. Change = (Baseline total cholesterol values - Week 8 total cholesterol values)
Time frame: Baseline and Week 8
Change from baseline in LDL cholesterol level with the use of placebo at week 8
Placebo capsules usually do not improve LDL cholesterol. Change = (Baseline LDL cholesterol values - Week 8 LDL cholesterol values)
Time frame: Baseline and Week 8
Change from baseline in triglyceride level with the use of placebo at week 8
Placebo capsules usually do not improve triglyceride levels. Change = (Baseline triglyceride values - Week 8 total triglyceride values)
Time frame: Baseline and Week 8
Change from baseline in fasting glucose level with the use of placebo at week 8
Placebo capsules usually do not improve fasting glucose levels. Change = (Baseline fasting glucose values - Week 8 total fasting glucose values)
Time frame: Baseline and Week 8
Change from baseline in fasting insulin level with the use of placebo at week 8
Placebo capsules usually do not improve fasting insulin levels. Change = (Baseline fasting insulin values - Week 8 fasting insulin values)
Time frame: Baseline and Week 8
Plan to share: Undecided
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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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