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Long-term Effectiveness Study on Cholesterol-reducing Activity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danone Research ( Danone Japan )
ClinicalTrials.gov Identifier:
NCT01521169
First received: January 26, 2012
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to investigate the effect of consumption of a drinkable low fat fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol (LDL-cholesterol) concentration during 12 weeks of product consumption.


Condition Intervention
Normal and Mild Hypercholesterolemic Subjects
 Other: 1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols).
Other: 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols).
Other: 3 - low-fat dairy fermented product (drinkable) without plant sterols.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
Official Title: Clinical Study for Evaluating the Plasma Cholesterol-reducing Activity of a Plant Sterol-enriched Yoghurt Drink - Effectiveness and Long-term Safety Study

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Danone Research:

Study Start Date: January 2010
Arms Assigned Interventions
Active Comparator: 1 = Tested product dose 1 Other: 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)
Active Comparator: 2 = Tested product dose 2 Other: 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)
Sham Comparator: 3 = Control product Other: 3 - low-fat dairy fermented product (drinkable) without plant sterols.
3 = Intervention 3 (1 control product/day)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject with total cholesterol plasma level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160 mg/dL.
  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:

  1. Subject currently involved in a clinical trial.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521169

Locations
Japan
Senrichuo Ekimae Clinic - Senri Life Science Center 13F
Osaka, Japan, 560-0082
Sponsors and Collaborators
Danone Japan
  More Information

No publications provided

Responsible Party: Danone Research ( Danone Japan )
ClinicalTrials.gov Identifier: NCT01521169     History of Changes
Other Study ID Numbers: NU332
Study First Received: January 26, 2012
Last Updated: June 26, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Danone Research:
Plant sterol - Hypercholesterolemia - Diet - Dairy

ClinicalTrials.gov processed this record on May 19, 2013