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Long-term Effectiveness Study on Cholesterol-reducing Activity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01521169
First Posted: January 30, 2012
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Danone Research ( Danone Japan )
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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:


Further study details as provided by Danone Research ( Danone Japan ):

Enrollment: 138
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521169


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

Responsible Party: Danone Japan
ClinicalTrials.gov Identifier: NCT01521169     History of Changes
Other Study ID Numbers: NU332
First Submitted: January 26, 2012
First Posted: January 30, 2012
Last Update Posted: October 27, 2016
Last Verified: October 2016

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