Long-term Effectiveness Study on Cholesterol-reducing Activity
NCT ID: NCT01521169
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
138 participants
INTERVENTIONAL
2010-02-28
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1 = Tested product dose 1
1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols).
1 = Intervention with test product 1 (0,8g of plant sterol/day)
2 = Tested product dose 2
2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols).
2 = Intervention with test product 2 (1,6g of plant sterol/day)
3 = Control product
3 - low-fat dairy fermented product (drinkable) without plant sterols.
3 = Intervention 3 (1 control product/day)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols).
1 = Intervention with test product 1 (0,8g of plant sterol/day)
2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols).
2 = Intervention with test product 2 (1,6g of plant sterol/day)
3 - low-fat dairy fermented product (drinkable) without plant sterols.
3 = Intervention 3 (1 control product/day)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject aged from 20 to 65 years (bounds included)
3. Subject with BMI between 19 - 30 kg/m² (bounds included)
4. Subject with triglycerides under 400 mg/dL (4.6 mmol/L)
5. Non diabetic subjects (BS≤125 mg/dL)
6. Non hypertensive subjects (SBP\<140mmHg and DBP\<90 mmHg)
7. Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic
8. Subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period
9. 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 and subject having signed the written consent to take part in the study
Exclusion Criteria
2. Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates)
3. 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 of the start of the present study.
4. For female subject: pregnancy or intention to be pregnant during the study.
5. For female subject: breast feeding.
6. Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products.
7. Subject having lactose intolerance.
8. Subjects having sitosterolemia
9. Diabetic subject (Type I and type II)
10. Subject with heavy alcohol intake (\>60g/day)
11. Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
12. Subject receiving a transplant or under immunosuppressor treatment
13. Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders.
14. Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angina pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months
15. Subject deemed unsuitable by the investigator.
20 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Danone Japan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Senrichuo Ekimae Clinic - Senri Life Science Center 13F
Osaka, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NU332
Identifier Type: -
Identifier Source: org_study_id