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:
Danone Research
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
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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
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 May 22, 2013