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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014