"A Clinical Study for Evaluating the Effect of a Plant Sterol-enriched Fermented Dairy Product on Blood Lipoprotein Profile in Japanese Adults"

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2016
• Main ID: NCT02268318
• Date of registration: 16/10/2014
• Prospective Registration: No
• Primary sponsor: Danone Japan
• Public title: "A Clinical Study for Evaluating the Effect of a Plant Sterol-enriched Fermented Dairy Product on Blood Lipoprotein Profile in Japanese Adults"
• Scientific title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL STUDY TO EVALUATE THE EFFECT OF A 12-WEEK CONSUMPTION PERIOD OF SINGLE DOSE A DAY OF A PLANT STEROL-ENRICHED FERMENTED DAIRY PRODUCT ON BLOOD LIPOPROTEIN PROFILE IN JAPANESE ADULTS WITH HIGH LDL-C
• Date of first enrolment: January 2014
• Target sample size: 154
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02268318
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
• Phase: N/A

Countries of recruitment

Japan

Contacts

• Name: Christine MRINI, MD, PHD
• Affiliation: Danone Research Life Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- An individual must fulfil all of the following criteria in order to be eligible for
trial enrolment

To be checked at the inclusion visit (V1):

- II 01: Male/female subject, aged from 20 to 75 years (bounds included).

- II 02: Subject with body mass index (BMI) between 18.5 kg/m2 (bound included) and 30
kg/m2 (bound excluded).

- II 03: Subject with LDL-cholesterol blood level between 120 mg/dL (3.1 mmol/L) and
160 mg/dL (4.14 mmol/L) (bounds included).

- II 04: Subject with triglycerides under 200 mg/dL (2.3 mmol/L).

- II 05: Non hypertensive subject defined with Systolic Blood Pressure (SBP) <140 mmHg
and Diastolic Blood Pressure (DBP) <90 mmHg OR subject with treated and controlled
hypertension defined with SBP <140 mmHg and DBP <90 mmHg since at least 1 month.

- II 06: Subject who already received the dietary recommendations advisable for hyper
or borderline hyper-LDL cholesterolemic subjects (according to Japan Atherosclerosis
Society guidelines).

- II 07: Subject agreeing not to consume any supplements/ food products enriched with
plant sterols and plant stanols in any form and soy milk product during the study
period.

- II 08: Female subject must be postmenopausal for at least 12 months prior to trial
entry or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or bilateral
tubal ligation) OR if of child bearing potential, female subject must be using or
complying with one of the following medically approved methods of contraception such
as, but not exclusively:

- Oral birth control pills (at least 1 full monthly cycle prior to study product
administration);

- Intra-uterine device (IUD);

- Double barrier methods (such as condoms and spermicide);

- Abstinence, when in the opinion of the investigator, their occupation or life style
gives efficient evidence that abstinence will be maintained throughout the study and
for one month thereafter.

- II 09: Subject covered by social security or covered by similar system.

- II 10: Subject, upon briefing of the content of the present study, fully
understanding and agreeing to its objective; and being able to personally sign a
written informed consent.

- II 11: Subject having given written (dated and signed) inform consent to take part in
the study.

- II 12: Asian subjects originating from Japan.

- II 13: Subject who is able to communicate well with the investigator and to comply
with the requirements of the entire study.

- II 14: Subject having a fridge at home for study products storage with sufficient
capacity.

To be checked at the randomization visit (V2):

- RI 01: Subject with LDL-cholesterol blood level between 120 mg/dL (3.1 mmol/L) and
160 mg/dL (4.14 mmol/L) (bounds included).

- RI 02: Subject with triglycerides under 200 mg/dL (2.3 mmol/L).

- RI 03: Subject having compliance to the product during the run-in period 80%.

- RI 04: Subject having followed the dietary recommendations advisable for
hypercholesterolaemic patients.

Exclusion Criteria:

- An individual fulfilling any of the following criteria is to be excluded from trial
enrolment

To be checked at the inclusion visit (V1):

- IE 01: Subject under hypocholesterolaemic treatment.

- IE 02: Subjects having stopped taking their hypocholesterolemic drugs or products
(statins, ezetimibe, sequesterants, niacin, nicotinates, probucol, omega-3 fatty
acids (EPA-DHA, ALA…), and fibrates) less than 3 months ago.

- IE 03: Subject with known allergy or hypersensitivity to plant sterols and to any
component of the study product (milk protein for example).

- IE 04: Subjects having sitosterolemia.

- IE 05: Subject having experienced any cardiovascular event (cardiac infarction,
angina attack, surgical or endoscopic coronary angioplasty, stroke, arterial disease,
etc.).

- IE 06: Subject suffering from any serious or chronic liver, renal, cardiovascular,
respiratory, endocrine or metabolic disorders.

- IE 07: Subject with gastro-intestinal disorders (such as diarrhoea, constipation,
irritable bowel syndrome) or using laxatives.

- IE 08: Subject with diabetes Type I and Type II or Fasting Blood Sugar test (FBS) >
125 mg/dL (7.0 mmol/L) at screening visit.

- IE 09: Subject who had any surgery or intervention requiring a general anesthesia in
the preceding 4 weeks, or who plans to have one during the course of the study.

- IE 10: Subject receiving (currently or in the 4 last weeks) systemic treatment or
topical treatment likely to interfere with evaluation of the study parameters.

- IE 11: Subject involved in any other clinical study within the preceding month or in
the exclusion period after another clinical study.

- IE 12: Subject having blood sample of 200 mL or more taken (e.g., donated blood)
within 1 month, or 400 mL or more within 3 months before the start of the present
study.

- IE 13: Subject with heavy alcohol intake (> 60 g/day).

- IE 14: Subject taking any treatment for anorexia, weight loss, or any form of
treatment likely to interfere with metabolism or dietary habits (e.g. hypolipemic,
hypoglycaemic treatments).

- IE 15: For female subject: pregnant woman or woman planning to become pregnant during
the study; breast-feeding woman.

- IE 16: For female subject: subject likely to change her contraceptive method or
hormone replacement therapy during the study.

- IE 17: Subject in a situation, which in the investigator's opinion could interfere
with optimal participation in the present study (e.g. non-dairy-products consumer) or
could constitute a special risk for the subject.

- IE 18: Subject who is susceptible to not comply with dietary qualitative restriction
during the study period.

- IE 19: Vulnerable subjects defined as individuals whose willingness to volunteer in
the clinical trial may be unduly influenced by the expectation, whether justified or
not, of benefits associated with participation, or of a retaliatory response from
senior members of a hierarchy in case of refusal to participate. Examples are members
of a group with a hierarchical structure, such as medical, pharmacy, dental and
nursing students, subordinate hospital and laboratory personnel, employees of the
pharmaceutical industry, members of the armed forces, and persons kept in detention.



Age minimum: 20 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Subjects With High LDL-Cholesterol

Intervention(s)

Other: 2-Fermented dairy Product with No Phytosterols (control)

Other: 1-Fermented Dairy Product with Phytosterols (test)

Primary Outcome(s)

Evolution of LDL-cholesterol concentration after 6 weeks of product consumption, expressed as a relative change from baseline. [Time Frame: baseline and 6 weeks]

Secondary Outcome(s)

- Evolution of LDL-cholesterol concentration after 6 weeks of product consumption, expressed as a raw change from baseline. - Evolution of LDL-cholesterol concentration after 3 and 12 weeks of product consumption, expressed as a relative and raw changes [Time Frame: baseline, 3 / 6 / 12 weeks]

Secondary ID(s)

NU359

Source(s) of Monetary Support

Please refer to primary and secondary sponsors