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

NCT02268318 | Completed

• 1 other identifier: NU359
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

INVESTIGATE THE EFFECT OF A 12-WEEK CONSUMPTION PERIOD OF SINGLE DOSE A DAY OF A PLANT STEROLS-ENRICHED FERMENTED DAIRY PRODUCT ON BLOOD LIPOPROTEIN PROFILE IN JAPANESE ADULTS WITH HIGH LDL-C.

Conditions

Subjects With High LDL-Cholesterol

Keywords

Japanese Subjects, High LDL-C, fermented-dairy products, phytosterols

Outcome Measures

Primary Outcomes (1)

• Evolution of LDL-cholesterol concentration after 6 weeks of product consumption, expressed as a relative change from baseline.

  baseline and 6 weeks

Secondary Outcomes (1)

• - 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

  baseline, 3 / 6 / 12 weeks

Study Arms (2)

1-Fermented Dairy Product with Phytosterols (test)

EXPERIMENTAL

one arm active = 1 bottle of dairy product/day with 1,6g of phytosterols

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

2-Fermented dairy Product with No Phytosterols (control)

PLACEBO COMPARATOR

one arm control product= 1 bottle of dairy product/day with no Phytosterols

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

Interventions

1-Fermented Dairy Product with Phytosterols (test) OTHER

1- 1 bottle of test product/day

1-Fermented Dairy Product with Phytosterols (test)

2-Fermented dairy Product with No Phytosterols (control) OTHER

2-1 bottle of control product/day

2-Fermented dairy Product with No Phytosterols (control)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Danone Japan: lead

Study Sites (1)

Yaesu Sakura-dori Clinic

Tokyo, 103-0028, Japan

Location

MeSH Terms

Interventions

Phytosterols

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Study Officials

• Christine MRINI, MD, PHD

  Danone Research Life Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 20, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

JP (1)