Status:
COMPLETED
Cholesterol Absorption Inhibition Study
Lead Sponsor:
Unilever R&D
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Cholesterol Absorption Inhibition
Eligibility:
MALE
20-65 years
Phase:
NA
Brief Summary
Rationale: Consuming Plant Sterols (PS) fortified foods is widely accepted as easy to apply, life-style change to combat modestly elevated plasma cholesterol concentrations. PS are typically formulate...
Eligibility Criteria
Inclusion
- Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).
- Males aged 20 - 65
- BMI 20-27 kg∙m-2
- LDL-C levels between 3.0 - 5.0 mmol/L, triglycerides \< 3.0 mmol/L
- Not more than 10 hours per week of strenuous exercise
- Ability to give informed consent.
- Ability to follow verbal and written instructions.
- Non-smoker (tobacco, marijuana).
- The ability to attend and to commute to the performance site for each of study day visit and follow-up throughout the study period are required.
- Willing to consume a breakfast in the morning of each study day.
- Willing to consume margarine on each study occasion.
- Having a general practitioner.
- No use of medication which interferes with study measurements (as judged by the study physician).
- Agreeing to be informed about medically relevant personal test-results after the screening visit by a physician.
- Consumption =\< 21 alcoholic drinks in a typical week.
- No blood donation 1 month prior to pre-study examination or during the study.
- Has accessible veins on the forearm as determined by examination at screening.
- Not being an employee of Unilever.
- No reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
- No reported participation in night shift work during the study.
Exclusion
- Unwilling to refrain from consumption of plant sterol or stanol containing products one week before and during the study..
- Plasma lipid profile which indicates deviating lipid / cholesterol homeostasis, to be judged by study physician.
- Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hemato¬logical/ immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/ connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/ psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- Gastrointestinal or hepatic disorders influencing gastrointestinal absorption or transit, including gallstones or biliary diseases.
- History of surgery related to the gastro-intestinal tract
- On a medically prescribed or weight reduction diet
- Recreational (intravenous) drug use.
- The use of psychotropic drugs, including: benzodiazepines or alcohol in excess of 21 units/ week for males
- Concomitant medication that may modulate gastro-intestinal secretions and pH (e.g. antacids, proton-pump-inhibitors, prostaglandins, anticholinergic agents, H2-receptor antagonists)
- Concomitant medication that can alter gastric emptying (e.g. metoclopramide, cisapride, domperidone and erythromycin, anticholinergics, tricyclic antidepressants, narcotic analgesics, adrenergic agents, calcium channel blockers)
- Concomitant medication that can alter intestinal transit (e.g. loperamide, chemical/ osmotic/bulk laxatives), or influence satiety/energy intake (e.g. sibutramine, gluco¬corticoids, anabolic steroids)
- Intolerance or allergy for test product.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01138787
Start Date
June 1 2010
End Date
November 1 2010
Last Update
May 4 2017
Active Locations (1)
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1
Academisch Medisch Centrum, vasculaire geneeskunde
Amsterdam, North Holland, Netherlands