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

Not Applicable

Completed

• Conditions: Mild Hypercholesterolemia; Healthy
• Interventions: 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

• Registration Number: NCT01629888
• Lead Sponsor: Danone Japan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-04
• Study Completion: 2010-06
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-28
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 = Tested product	1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).	-
2 = Control product	2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters	-

Trial Locations

Locations (1)

Senri Chuo Ekimae Clinic; 🇯🇵 Osaka, Japan