Cholesterol Absorption InhibitionCASTELLNCT01138787
Cholesterol Absorption Inhibition Study
A study testing Reference spread and Test spread in people with Cholesterol Absorption Inhibition, run by Unilever R&D at 1 site in Netherlands.
Trial 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 formulated as PS fatty acid ester (PSE) from margarines. In this study, PS will be formulated in a new innovative type spread. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cholesterol Absorption Inhibition
- What is being tested?
- Reference spread and Test spread
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2010to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academisch Medisch Centrum, vasculaire geneeskunde
Amsterdam, North Holland
About this study
Official title: CASTELL = Cholesterol Absorption Study STErols (LL)
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 formulated as PS fatty acid ester (PSE) from margarines. In this study, PS will be formulated in a new innovative type spread. To confirm that the new spread results in a comparable cholesterol absorption inhibition as the reference product a dual isotope cholesterol study is planned, prior to any larger efficacy study.
Primary 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.
Read more
Secondary objectives: PK parameters for cholesterol as derived from the plasma concentration vs. time curves.
Study design: Acute, single dose, double-blind, randomized, cross-over. Study population: 18 healthy, non-obese men (BMI 20-27 kg∙m-2, age range 20 - 65 yr) Test products: PS (2250 mg) formulated in innovatively processed spread (30 g); PSE (2250 mg PS) reference product (30 g); Control product without PS or PSE (30 g) Intervention: Three study periods during which a single dose of either Test, Reference or Control (regular light spread) 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.
Key parameters: Enrichments of labeled cholesterol isotopes as determined by GCMS and IRMS. Fractional absorption is determined by the ratio of the two isotopes in plasma cholesterol after 7 days.
- Conditions
- Cholesterol Absorption Inhibition
- Being tested
- Reference spread, Placebo spread, Test spread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference spreadDietary supplement
Single dose (30 gr) of spread, containing 2250 mg PS
Placebo spreadDietary supplement
Single dose (30 gr) of regular light margarine
Test spreadDietary supplement
Single dose (30 gr) of innovatively processed spread containing 2250 mg PS.
| Study group | Role | What they receive |
|---|---|---|
| Reference spread | Active comparator | 2250 mg PS (as PSE) in spread (30 g)
* 50 mg labeled D7-cholesterol,
* 30 mg 3,4-13C-cholesterol, iv dosed at same time. Receives: Dietary Supplement: Reference spread |
| Placebo spread | Placebo comparator | regular light margarine (30 g)
* 50 mg labeled D7-cholesterol,
* 30 mg 3,4-13C-cholesterol, iv dosed at same time. Receives: Dietary Supplement: Placebo spread |
| Test spread | Experimental | 2250 mg PS in innovatively processed spread (30 g)
* 50 mg labeled D7-cholesterol,
* 30 mg 3,4-13C-cholesterol, iv dosed at same time. Receives: Dietary Supplement: Test spread |
What is being measured
The primary outcome is the main question the study is designed to answer.
cholesterol absorption calculated from plasma cholesterol enrichments vs. time curves
Measured: 5 blood samples within one week for each intervention
Secondary outcomes (1)
PK parameters derived from plasma curves (Cmax, Tmax, cholesterol pool, flux).
Measured: 5 blood samples within one week for each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol Absorption InhibitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Maud N Vissers, Dr. Ir, Principal investigator, Academisch Medisch Centrum, afdeling vasculaire geneeskundeGuus SM Duchateau, Dr, Study director, Unilever Research & Development Vlaardingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138787
- Sponsor's protocol ID
- 09030V
- Acronym
- CASTELL
- Status last verified
- May 2017
- First submitted
- 4 Jun 2010
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CASTELL = Cholesterol Absorption Study STErols (LL)
- ClinicalTrials.gov ID
- NCT01138787
- Acronym / sponsor ID
- CASTELL / 09030V
- Conditions
- Cholesterol Absorption Inhibition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- Jun 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 formulated as PS fatty acid ester (PSE) from margarines. In this study, PS will be formulated in a new innovative type spread. To confirm that the new spread results in a comparable cholesterol absorption inhibition as the reference product a dual isotope cholesterol study is planned, prior to any larger efficacy study.
Primary 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.
Secondary objectives: PK parameters for cholesterol as derived from the plasma concentration vs. time curves.
Study design: Acute, single dose, double-blind, randomized, cross-over. Study population: 18 healthy, non-obese men (BMI 20-27 kg∙m-2, age range 20 - 65 yr) Test products: PS (2250 mg) formulated in innovatively processed spread (30 g); PSE (2250 mg PS) reference product (30 g); Control product without PS or PSE (30 g) Intervention: Three study periods during which a single dose of either Test, Reference or Control (regular light spread) 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.
Key parameters: Enrichments of labeled cholesterol isotopes as determined by GCMS and IRMS. Fractional absorption is determined by the ratio of the two isotopes in plasma cholesterol after 7 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference spread | Active comparator | Dietary Supplement: Reference spread2250 mg PS (as PSE) in spread (30 g) * 50 mg labeled D7-cholesterol, * 30 mg 3,4-13C-cholesterol, iv dosed at same time. |
| Placebo spread | Placebo comparator | Dietary Supplement: Placebo spreadregular light margarine (30 g) * 50 mg labeled D7-cholesterol, * 30 mg 3,4-13C-cholesterol, iv dosed at same time. |
| Test spread | Experimental | Dietary Supplement: Test spread2250 mg PS in innovatively processed spread (30 g) * 50 mg labeled D7-cholesterol, * 30 mg 3,4-13C-cholesterol, iv dosed at same time. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reference spreadSingle dose (30 gr) of spread, containing 2250 mg PS | Dietary supplement | Reference spread |
| Placebo spreadSingle dose (30 gr) of regular light margarine | Dietary supplement | Placebo spread |
| Test spreadSingle dose (30 gr) of innovatively processed spread containing 2250 mg PS. | Dietary supplement | Test spread |
Primary outcome
cholesterol absorption calculated from plasma cholesterol enrichments vs. time curves
Time frame: 5 blood samples within one week for each intervention
1 secondary outcome
PK parameters derived from plasma curves (Cmax, Tmax, cholesterol pool, flux).
Time frame: 5 blood samples within one week for each intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maud N Vissers, Dr. Ir principal investigator
Academisch Medisch Centrum, afdeling vasculaire geneeskunde
Guus SM Duchateau, Dr study director
Unilever Research & Development Vlaardingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference spread and Test spread in people with Cholesterol Absorption Inhibition, run by Unilever R&D at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cholesterol absorption calculated from plasma cholesterol enrichments vs. time curves (time frame: 5 blood samples within one week for each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.