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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01629888

Enrollment

Registered

2012-06-28

Start date

2010-02-28

Completion date

2010-06-30

Last updated

2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Mild Hypercholesterolemia

Keywords

Plant sterol, Hypercholesterolemia, dairy

Brief summary

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.

Interventions

OTHER1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).

1 = Intervention 1 (3 test products/day)

OTHER2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters

2 = Intervention 2 (3 control products/day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026