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

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.

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