Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols

Hypercholesterolemia Clinical Trial

Official title:

Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340287
• Other study ID #: NU281
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: October 26, 2016
• Start date: July 2008
• Est. completion date: August 2009

Study information

• Verified date: October 2016
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in midly hypercholesterolemic people not treated by statins.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• male/female subject,

• aged from 21 to 75 years,

• BMI between 19 and 30 kg/m2,

• LDL-cholesterol plasma level between 130 and 190 mg/dL without statin monotherapy,

• stabilized hypercholesterolemia,

• accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),

• used to consume dairy products,

• effective contraceptive methods used for female subjects,

• having given written consent to take part in the study

Exclusion Criteria:

• subject with plasma triglycerides (TG) levels = 350 mg/dL,

• having experienced any cardiovascular event in the last 6 months,

• taking any hypocholesterolemic treatment,

• diabetic subject (type I and type II),

• smoking strictly more than 10 cigarettes / day,

• heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women),

• presenting known allergy or hypersensitivity to milk proteins,

• known soy allergy,

• refusing to stop the consumption of plant sterols-enriched products (other than the studied product),

• receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,

• receiving a transplant and under immunosuppressor treatment,

• currently involved in a clinical trial or in an exclusion period following participation in another clinical trial,

• in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,

• with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product,

• for female subject: pregnancy, breast feeding or intention to be pregnant during the study or subject likely to change her contraceptive method during the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
1 = Intervention 1 (1 test product/day)
• 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
2 = Intervention 2 (1 control product/day)

Locations

Country	Name	City	State
United States	Renstar Medical Research	Ocala	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

United States,