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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629888
• Other study ID #: NU336
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: October 7, 2016
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: October 2016
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy
• Hypercholesterolemia
• Mild Hypercholesterolemia

Intervention

Other:
• 1- 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)
• 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
2 = Intervention 2 (3 control products/day)

Locations

Country	Name	City	State
Japan	Senri Chuo Ekimae Clinic	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Danone Japan

Country where clinical trial is conducted

Japan,