Long-term Effectiveness Study on Cholesterol-reducing Activity

Clinical Study for Evaluating the Plasma Cholesterol-reducing Activity of a Plant Sterol-enriched Yoghurt Drink - Effectiveness and Long-term Safety Study

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.

Study Overview

• Status: Completed
• Conditions: Normal and Mild Hypercholesterolemic Subjects
• Intervention / Treatment: 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
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 560-0082
    • Senrichuo Ekimae Clinic - Senri Life Science Center 13F

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

Collaborators and Investigators

• Sponsor: Danone Japan

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 26, 2012
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Plant sterol - Hypercholesterolemia - Diet - Dairy
• Other Study ID Numbers: NU332