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

NCT01340287 | Completed

• 1 other identifier: NU281
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypercholesterolemia

Keywords

Plant sterol; Hypercholesterolemia; diet; dairy; isoprostanes; Midly hypercholesterolemic subjects

Study Arms (2)

1 = Tested product

ACTIVE COMPARATOR

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

2 = Control product

SHAM COMPARATOR

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

Interventions

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

1 = Intervention 1 (1 test product/day)

1 = Tested product

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

2 = Intervention 2 (1 control product/day)

2 = Control product

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

Renstar Medical Research

Ocala, Florida, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 22, 2011
• Study Start: July 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

US (1)