Long-term Effectiveness Study on Cholesterol-reducing Activity

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.

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Key information

Conditions

Normal and Mild Hypercholesterolemic Subjects

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Senrichuo Ekimae Clinic - Senri Life Science Center 13F

Osaka, 560-0082, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
Subject aged from 20 to 65 years (bounds included)
Subject with BMI between 19 - 30 kg/m² (bounds included)
Subject with triglycerides under 400 mg/dL (4.6 mmol/L)
Non diabetic subjects (BS≤125 mg/dL)
Non hypertensive subjects (SBP<140mmHg and DBP<90 mmHg)
Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic
Subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period
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

Subject currently involved in a clinical trial.
Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates)
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.
For female subject: pregnancy or intention to be pregnant during the study.
For female subject: breast feeding.
Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products.
Subject having lactose intolerance.
Subjects having sitosterolemia
Diabetic subject (Type I and type II)
Subject with heavy alcohol intake (>60g/day)
Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
Subject receiving a transplant or under immunosuppressor treatment
Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders.
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
Subject deemed unsuitable by the investigator.

Treatment and study plan

1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols).

Other

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).

Other

2 = Intervention with test product 2 (1,6g of plant sterol/day)

3 - low-fat dairy fermented product (drinkable) without plant sterols.

Other

3 = Intervention 3 (1 control product/day)

Sponsors and collaborators

Lead sponsor

Danone Japan

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jan 30, 2012
Registry last updated: Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.