Efficacy of Lactobacillus Mucosae DPC6426 on Blood-lipids

Inclusion criteria

• Be able to give written informed consen
• Be between 20 and 70 years of age,
• Subjects are mildly hypercholesterolaemic, with a total cholesterol level >5.5 mmol/L and <8mmol/L,
• Subject has a BMI of between 18.5 - 32 Kg/m2,
• Have a stable body weight (< 5% change) over the past 3-months, -Subject is in general good health as determined by the investigator.

Exclusion criteria

• Are less than 20 and greater than 70 years of age,
• Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:

• non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
• child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 7. The subject must also agree to one of the following methods of contraception: i. Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or, ii. has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or, iii. sexual partner(s) is/are exclusively female or, iv. Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception for 1 week following discontinuation of study medication), v. Use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm). The subject must be using this method for at least 1 week following the end of the study or, vi. Use of any intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1% per year. The subject must have the device inserted at least 2 weeks prior to the first Screen Visit, throughout the study, and 2 weeks following the end of the study.
• Subject is a smoker,
• Are hypersensitive to any of the components of the test product,
• Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study,
• Subject is taking a probiotic or prebiotic product/supplement or have taken them within two weeks of the screening visit,
• Subject has received a blood transfusion within the previous 6 months,
• Subjects has taken antibiotics within the previous 3 months,
• Subject has a history of drug and/or alcohol abuse at the time of enrolment,
• Have a Gamma-GT outside the normal range,
• Have an active gastrointestinal disorder or previous gastrointestinal surgery,