Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols

This study has been completed.
Sponsor:
Collaborator:
McGill University
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01571869
First received: April 3, 2012
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.


Condition Intervention
Mildly Hypercholesterolemic Subjects
Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit
Other: 2- Low fat drinkable fermented dairy product without plant sterols (control)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Official Title: Influence of a Meal on the Efficacy of Plant Sterol Given at Different Times of the Day in Management of Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Danone Research:

Enrollment: 30
Study Start Date: May 2005
Arms Assigned Interventions
Experimental: 1 = Tested product Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit
1-Intervention with test product (morning, evening or snack)
Placebo Comparator: 2 = Control product Other: 2- Low fat drinkable fermented dairy product without plant sterols (control)
2 - Intervention with control product (morning and/or evening)

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male and post-menopausal female aged 40-80 years;
  • BMI between 22 and 32 kg/m2,
  • Non-smoker, Stabilized LDL-c over 3.0 mmol/L,
  • Not taking any medication known to affect lipid metabolism for at least the previous 3 month period,
  • Agree to follow the dietary recommendations in the context of their hypercholesterolemia,
  • Have to give written consent to take part in the study

Exclusion Criteria:

  • Thyroid disease, diabetes mellitus, kidney disease or liver disease, Hypertension (95<SBP>140 mmHg and/or 45<DBP>90 mmHg),
  • Previous history of symptomatic vascular disease, TG level > 2,8 g/l,
  • History of metabolic or gastrointestinal disease with the exception of appendicectomy,
  • Consumption of large amounts of alcohol,
  • Having undergone general anesthesia in the month prior to pre-selection,
  • Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
  • Having serious or acute disease likely to influence study results or involved in life time,
  • Presenting allergy or hypersensitivity to milk proteins, or refusing to consume them,
  • Refusing to stop his/her consumption of enriched plant sterol trade products during the study,
  • 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,
  • For female subjects: likely to change her hormonal substitutive treatment,
  • Currently in an exclusion period following participation in another clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571869

Locations
Canada, Quebec
McGill University
Ste-anne-de-bellevue, Quebec, Canada, H9X 3V9
Sponsors and Collaborators
Danone Research
McGill University
  More Information

No publications provided

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01571869     History of Changes
Other Study ID Numbers: NU142
Study First Received: April 3, 2012
Last Updated: April 4, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Danone Research:
Plant sterol - hypercholesterolemia - dairy - meal

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 22, 2014