The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum in Hypercholesterolaemic Adults (PROBIOCHOL)
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ClinicalTrials.gov Identifier: NCT03263104 |
Recruitment Status :
Completed
First Posted : August 28, 2017
Last Update Posted : August 28, 2017
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Dietary Supplement: Lactobacillus plantarum ECGC 13110402 Dietary Supplement: Maltodextrin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Single-centre, prospective, randomised, placebo-controlled, parallel-group design to determine the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Double Blind (Participant, Investigator,Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Single-centre, Prospective, Randomised, Placebo-controlled, Parallel-group Design to Determine the Cholesterol-lowering Efficacy of Lactobacillus Plantarum ECGC 13110402 in Normal to Mildly Hypercholesterolaemic Adults |
Actual Study Start Date : | January 2015 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
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Experimental: Lactobacillus plantarum ECGC 13110402
Lactobacillus plantarum ECGC 13110402 equivalent to 2x10^9 CFU (0.1 g) with the addition of filling carrier (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed twice daily, before breakfast and dinner with 250mL of water.
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Dietary Supplement: Lactobacillus plantarum ECGC 13110402
Lactobacillus plantarum ECGC 13110402 |
Placebo Comparator: Maltodextrin
Maltodextrin (an oligosaccharide without prebiotic effect) (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed twice daily, before breakfast and dinner with 250mL of water.
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Dietary Supplement: Maltodextrin |
- Modulation of the blood lipids by L. plantarum ECGC 13110402 The modulation of the blood lipids by L. plantarum ECGC 13110402 [ Time Frame: Changes from baseline to 6-12 week treatment period with the probiotic ]Effects of the probiotic on TC, LDL-C, HDL-C and TAG
- Modulation of immune function by L. plantarum ECGC 13110402 [ Time Frame: Changes from baseline to 6-12 week treatment period with the probiotic ]Blood samples analysis to assess changes in cytokines production Blood samples analysis to assess changes in cytokines production Blood samples analysis to assess changes in cytokines production
- Digestive symptoms [ Time Frame: Changes from baseline to 6-12 week treatment period with the probiotic ]Bristol diary form Bristol diary form
- Microbiota changes [ Time Frame: Changes from baseline to 6-12 week treatment period with the probiotic ]DNA profiling from faeces

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- aged between 18 and 50 years of age.
- in good general health, defined as no comorbidities requiring regular
- medical follow up
- ability to communicate well with the investigator and to comply with the
- requirements of the entire study
- BMI 18.5 to 29.9 kg/m2
- total cholesterol (TC) between 200 and 300 mg/dl (5.16 and 7.64 mmol/L).
Exclusion Criteria:
- History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years
- Consumed probiotic or prebiotic preparations on a regular basis (at least 3
- times per week) in the last 2 weeks and during the trial period
- Former participation in another study involving prebiotic or probiotic
- preparations or investigational drugs within the previous 6 months, or
- intention to use such drugs during the course of the study
- high blood cholesterol or use of cholesterol lowering drugs
- Undergone surgical resection of any part of the bowel
- History of malignancy within the previous 5 years (with exception of well-
- treated basal cell carcinoma or in situ cervical carcinoma).
- Currently prescribed immunosuppressive drugs
- Intention to use regularly other medication which affects gastrointestinal
- motility and/or perception
- Current or recent history (within 12 months) of significant drug or alcohol
- abuse or dependence

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263104
Study Director: | Glenn R Gibson | The University of Reading |
Responsible Party: | DR ADELE COSTABILE, Health Sciences Research Centre, Life Science Department, University of Roehampton |
ClinicalTrials.gov Identifier: | NCT03263104 |
Other Study ID Numbers: |
UREC 15/06 |
First Posted: | August 28, 2017 Key Record Dates |
Last Update Posted: | August 28, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |