A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink

The purpose of this study is to investigate the safety of consumption of three times the standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.

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Key information

Conditions

Healthy Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Mild Hypercholesterolemia Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Senri Chuo Ekimae Clinic

Osaka, 560-0082, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

male/female subjects,
aged 20-65 years old,
triglycerides (TG) levels under 400 mg/dL,
total cholesterol plasma level under 240 mg/dL (with half the subjects at entry under 200 mg/dL),
LDL-cholesterol plasma level under 160 mg/dL (with half the subjects at entry under 120 mg/dL),
non diabetic and non hypertensive,
accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (Japan Atherosclerosis Society guidelines),
effective contraceptive methods used for female subjects,
having given written consent to take part in the study

Exclusion criteria

subjects with sitosterolemia,
subjects with 200 ml of blood taken within the past month or 400 ml or more within the past 3 months,
taking any hypocholesterolemic treatment,
presenting known allergy or hypersensitivity to plant sterols,
dairy products and lactose, subject with heavy alcohol intake (> 60g/day),
receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
subjects receiving a transplant or under immunosuppressor treatment,
receiving treatment for any serious pathology.
for female subject:

pregnancy,
breast feeding or
intention to be pregnant during the study

Treatment and study plan

1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).

Other

1 = Intervention 1 (3 test products/day)

2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters

Other

2 = Intervention 2 (3 control products/day)

Sponsors and collaborators

Lead sponsor

Danone Japan

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jun 28, 2012
Registry last updated: Oct 10, 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.

Published trials that share one or more normalized conditions with this study.

Completed