Effect of Different Probiotic Strains in Hypercholesterolemic Patients

NCT04701775 | Completed

• 1 other identifier: 2018/60-26
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemias

Keywords

serum lipids; hyperlipidemia; probiotics

Outcome Measures

Primary Outcomes (5)

• 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)

  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)

  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)

  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)

  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)

  Baseline and Week 8

Secondary Outcomes (5)

• Change from baseline in total cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8

  Baseline and Week 8

• Change from baseline in LDL cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8

  Baseline and Week 8

• Change from baseline in triglyceride level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8

  Baseline and Week 8

• Change from baseline in fasting glucose level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8

  Baseline and Week 8

• Change from baseline in fasting insulin with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8

  Baseline and Week 8

Other Outcomes (5)

• Change from baseline in total cholesterol level with the use of placebo at week 8

  Baseline and Week 8

• Change from baseline in LDL cholesterol level with the use of placebo at week 8

  Baseline and Week 8

• Change from baseline in triglyceride level with the use of placebo at week 8

  Baseline and Week 8

Study Arms (3)

Lactobacillus rhamnosus GG Group

EXPERIMENTAL

Participants received only 1x106 cfu Lactobacillus rhamnosus GG once a day for 8 weeks.

Dietary Supplement: Only Lactobacillus rhamnosus GG strains

Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis Group

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Those participants received placebo capsule once a day for 8 weeks.

Other: Placebo

Interventions

Only Lactobacillus rhamnosus GG strains DIETARY_SUPPLEMENT

1x106 colony forming unit (CFU) Lactobacillus rhamnosus GG probiotic capsule

Lactobacillus rhamnosus GG Group

Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains COMBINATION_PRODUCT

combination of Lactobacillus acidophilus 1x109 CFU and Bifidobacterium animalis subsp.lactis 1x109 CFU probiotic capsule

Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis Group

Placebo OTHER

Placebo probiotic capsule

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Gözde Okburan

Famagusta, Cyprus

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gözde Okburan

  Eastern Medittanean University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant. Prof. Dr.

Model Details: Double-blind randomized controlled trial

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: January 8, 2021
• Study Start: September 28, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 7, 2019
• Last Updated: January 12, 2021

Record last verified: 2020-12

Locations

CY (1)