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

Danone

Status: Completed

Conditions: Healthy; Mild Hypercholesterolemia

Treatments: Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).; Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters

Study type: Interventional

Funder types: Industry

Identifiers

NCT01629888

NU336

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

48 participants in 2 patient groups, including a placebo group

1 = Tested product

Experimental group

Treatment:

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

2 = Control product

Placebo Comparator group

Treatment:

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