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OpenTrials
Completed

NCT Number: NCT01571869

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University

Ste-anne-de-bellevue, Quebec, H9X 3V9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit

Other

1-Intervention with test product (morning, evening or snack)

2- Low fat drinkable fermented dairy product without plant sterols (control)

Other

2 - Intervention with control product (morning and/or evening)

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

Influence of a Meal on the Efficacy of Plant Sterol Given at Different Times of the Day in Management of Hypercholesterolemia

Important dates

Study start
2005
Primary completion
2005
Study completion
2006
First posted
Apr 5, 2012
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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