Cholesterol absorption inhibition (%) calculated from plasma concentration vs. time curves from labeled cholesterol, for the PS or PSE containing products, compared to a control product without PS or PSE.
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Enrichments of labeled cholesterol isotopes as determined by GCMS and IRMS in
plasma. Fractional absorption is determined by the ratio of the two isotopes in
plasma cholesterol over 7 days.
Secondary outcome
PK parameters (for labeled cholesterol) derived from plasma curves (Cmax, Tmax,
cholesterol pool, flux).
Background summary
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 formulated as PS fatty acid ester (PSE) from
margarines. Such products could further be improved to increase impact at a
population level. To explore this, PS will be formulated in a new innovative
type spread. The use of PS (instead of PSE) and the innovative process are two
changes from the current product with PSE (Reference). To confirm that the new
formulation and change from PSE to PS results in a comparable cholesterol
absorption inhibition as the reference product a dual isotope cholesterol study
is planned, prior to any larger efficacy study.
Such information is pivotal in the further development of the new spread with
consumer relevant benefits, such as: lower in saturated fats, increased
formulation space to include future relevant ingredients, and a more
sustainable process.
Study objective
Cholesterol absorption inhibition (%) calculated from plasma concentration vs.
time curves from labeled cholesterol, for the PS or PSE containing products,
compared to a control product without PS or PSE.
Study design
Acute, single dose, double-blind, randomized, cross-over.
Intervention
Three study periods during which a single dose of either Test, Reference or
Control (regular Becel light) spreads will be consumed together with standard
breakfast. At each study period, 50 mg of D7-cholesterol is added to the meal
and 30 mg of 13C-cholesterol is injected to measure cholesterol absorption.
Before and four times after consumption of each spread, blood samples will be
taken at 24 h intervals up to 7 days.
Study burden and risks
Total amount of blood drawn excluding screening, is 3 x 5 x 13.5 mL = 202.5 mL
over a period of 3 months.
Subjects are requested to pay 16 visits to the center, of which;
- 1 screening visit, including blood draw (13.5 mL) and a physical examination,
- 3 visits at start of each period including an iv injection, one blood draw
and administration of product and the orally dosed label (capsule),
- and per period, 4 more visits over 168 hr in total for blood draw.
For each period a diary is filled out to record dietary habits during the study
period.
The insertion of the canula for iv injection per period, and/or the
venapunctures for blood draws throughout each period can cause discomfort and
possibly local brusing.
There is no risk known associated to the consumption of regular or plant sterol
enriched margarines.
The study delivers no immediate benefit for the participating subjects, there
is only a research benefit on the long term from the data obtained.
PO Box 114
3130 AC Vlaardingen
NL
PO Box 114
3130 AC Vlaardingen
NL
Listed location countries
Age
Inclusion criteria
- Apparently healthy males aged 20 - 65 y
- BMI 20-27 kg/m2
- LDL-C levels between 3.0 * 5.0 mmol/L, triglycerides < 3.0 mmol/L
- Non-smoker (tobacco, marijuana).
- No use of medication which interferes with study measurements
- Consumption <=< 21 alcoholic drinks in a typical week.
- 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 criteria
- Unwilling to refrain from consumption of plant sterol or stanol containing products, e.g. Becel pro.activ, Benecol, etc one week before and during the study
- Plasma lipid profile which indicates deviating lipid / cholesterol homeostasis
- Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/ 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, glucocorticoids, anabolic steroids)
- Intolerance or allergy for test product.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31924.018.10 |
| Other | will follow asap |