search
Back to results

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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
Sponsored by
Danone Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypercholesterolemia focused on measuring Plant sterol, Hypercholesterolemia, diet, dairy, isoprostanes, Midly hypercholesterolemic subjects

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Renstar Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

1 = Tested product

2 = Control product

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 21, 2011
Last Updated
October 26, 2016
Sponsor
Danone Research
search

1. Study Identification

Unique Protocol Identification Number
NCT01340287
Brief Title
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols
Official Title
Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Plant sterol, Hypercholesterolemia, diet, dairy, isoprostanes, Midly hypercholesterolemic subjects

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 = Tested product
Arm Type
Active Comparator
Arm Title
2 = Control product
Arm Type
Sham Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
Intervention Description
1 = Intervention 1 (1 test product/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
Intervention Description
2 = Intervention 2 (1 control product/day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs