HypercholesterolemiaNCT01825668
Effect of Plant Sterol Enriched Milk on Plasma Lipid Levels of Humans Breast-fed During Infancy
A study testing Plant Sterols and High cholesterol in people with Hypercholesterolemia and CVD, run by University of Manitoba at 1 site in Canada.
Trial summary
The overall goal of this clinical study is to investigate how dietary cholesterol intake influences the plasma Total cholesterol (TC), LDL-Cholesterol levels and cholesterol metabolism between adults who had been breast-fed as infants as a function of the duration of breast feeding and quantity of early cholesterol… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, CVD
- What is being tested?
- Plant Sterols and High cholesterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Jun 2016
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Triglycerides (TG) <3.0 mmol/L
- Body mass index (BMI) between 20 and 30 kg/m2
- Participants must have been breast-fed at least during the first 6 months of their life
Who cannot join
- History of recent (i.e. less than 1 month) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
- History of chronic use of alcohol (>2 drinks/d), smoking, systemic antibodies, corticosteroids, androgens, or phenytoin
- Myocardial infarction, coronary artery bypass, kidney disease, liver disease or other major surgical procedures within the last six months,
- Sitosterolemic patients
- Recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (i.e. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year)
- Exercise greater than walking or running 15 miles/wk or 4,000 kcal/wk
- Participants who have not been breast-fed at all
- Pregnant or planning for pregnancy during the next 5 month period
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Effect of a Plant Sterol-Fortified Low-fat Milk Product on Plasma Lipid Levels of Humans in Relation to Different Infant Feeding Practices and Later Life Cholesterol Metabolism
The overall goal of this clinical study is to investigate how dietary cholesterol intake influences the plasma Total cholesterol (TC), LDL-Cholesterol levels and cholesterol metabolism between adults who had been breast-fed as infants as a function of the duration of breast feeding and quantity of early cholesterol intake. The study also aims to evaluate the effect of a plant sterol formulation in low fat milk shake in modulating the lipid profile favorably in the study population.
Read the detailed description
Hypothesis 1: To determine the responsiveness of plasma lipid profile including Total cholesterol and LDL cholesterol concentrations to high and low cholesterol diets in adults who been breast-fed as infants for different durations
Hypothesis 2: To determine if differences exist in rates of cholesterol absorption and synthesis in adults, and whether such differences respond to variations in cholesterol intake, between individuals who were breast for different durations.
Hypothesis 3: Consumption of a plant sterol formulation in low-fat milk product will favorably alter lipid profiles compared with control in the study population.
This is a free-living, randomized, crossover trial. This trial is modeled after previously successful functional food trial at the investigators clinic, consistent with current recommendations to decrease Cardiovascular diseases (CVD) risk and improve circulating lipid profiles. The proposed study will include three treatment phases of 4 weeks each, separated by 4-week washout intervals:
Phase 1: Study diets with placebo (240 ml of 2% milk shake; 50 mg cholesterol).
Phase 2: Study diets with enriched cholesterol (240ml of 2% milk shake; 600 mg cholesterol).
Phase 3: A study diet with plant sterols (240 ml of 2% milk shake;2.0 g/d of plant sterols/240 ml serving; 50 mg cholesterol).
During each treatment period participants will consume their supper time meal along with assigned test product. Consumption of the suppertime meals and the test products will be monitored by a clinical coordinator to ensure compliance. Participants will be asked to fill out a 3-day food diary at the beginning and end of each experimental period.
- Conditions
- Hypercholesterolemia, CVD
- Being tested
- Plant Sterols, High cholesterol, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant SterolsOther
High cholesterolOther
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| High cholesterol | Experimental | 600 mg cholesterol/day in 240 ml milk shake Receives: Other: High cholesterol |
| Plant sterols | Experimental | 2.0 g of plant sterols/day in 240 ml milk shake containing 50 mg cholesterol Receives: Other: Plant Sterols |
| Placebo | Placebo comparator | 50 mg cholesterol/day in 240 ml of milk shake Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL-cholesterol
Measured: Day 1,2 & 29,30 of each of the 3 phases. Each phase duration is 1 month
Secondary outcomes (2)
Change in Cholesterol Absorption
On day 26 of each dietary phase,a 12-hr fasting blood sample will be obtained to represent stable isotope baseline, after which participants will ingest 75 mg of the stable carbon isotope [3,4-13C] cholesterol stable isotope (13C-cholesterol)dissolved in 5 g of margarine and spread on half of an English muffin. Fasting blood samples will be taken also on days 27, 28, and 29 to monitor isotopic enrichment/decay levels. Free cholesterol extracted from the Red Blood Cell (RBC) fraction of blood will be used to determine 13C-cholesterol enrichment using on-line gas chromatography (GC)/combustion/isotope ratio mass spectrometry (IRMS)using previously established methods. Carbon-di-oxide (CO2) gas will be analyzed for 13C cholesterol enrichment against the Pee Dee Belemnite (PDB). From 24 to 96 hr, cholesterol absorption will be presented as area under the 13C cholesterol RBC enrichment curve calculated by the Number cruncher statistical system (NCSS) statistical software.
Measured: Day 26-30 of each of the 3 phases. Each phase duration is 1 month
Change in Cholesterol Synthesis
On day 29 prior to breakfast, participants will consume 0.7 g/kg estimated body water (estimated at 60% of total body weight) of deuterium oxide (2H) as a tracer to measure cholesterol synthesis. Fasting blood sample will be collected after 24 hr (96 h after initial isotope administration) in order to monitor the change in deuterium enrichment within red blood cell (RBC) free cholesterol as an index of cholesterol synthesis.Free cholesterol will be extracted from RBC and water from plasma will be isolated using the blood samples collected from day 26-30 each phase. Cholesterol deuterium enrichment will be determined through being expressed relative to a series of standards using a GC/pyrolysis/IRMS using previously established methods. Cholesterol fractional synthesis rate (FSR) (% per day)will be calculated as the rate of incorporation of deuterium within the body water pool into RBC cholesterol pools by measuring the deuterium RBC enrichment over 24 hr.
Measured: Day 26-30 of each of the 3 phases. Each phase duration is 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter JH Jones, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825668
- Sponsor's protocol ID
- B2013:019
- Status last verified
- Mar 2013
- First submitted
- 21 Mar 2013
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Plant Sterol-Fortified Low-fat Milk Product on Plasma Lipid Levels of Humans in Relation to Different Infant Feeding Practices and Later Life Cholesterol Metabolism
- ClinicalTrials.gov ID
- NCT01825668
- Acronym / sponsor ID
- B2013:019
- Conditions
- Hypercholesterolemia, CVD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 8 Apr 2013 (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.
The overall goal of this clinical study is to investigate how dietary cholesterol intake influences the plasma Total cholesterol (TC), LDL-Cholesterol levels and cholesterol metabolism between adults who had been breast-fed as infants as a function of the duration of breast feeding and quantity of early cholesterol intake. The study also aims to evaluate the effect of a plant sterol formulation in low fat milk shake in modulating the lipid profile favorably in the study population.
Detailed description
Hypothesis 1: To determine the responsiveness of plasma lipid profile including Total cholesterol and LDL cholesterol concentrations to high and low cholesterol diets in adults who been breast-fed as infants for different durations
Hypothesis 2: To determine if differences exist in rates of cholesterol absorption and synthesis in adults, and whether such differences respond to variations in cholesterol intake, between individuals who were breast for different durations.
Hypothesis 3: Consumption of a plant sterol formulation in low-fat milk product will favorably alter lipid profiles compared with control in the study population.
This is a free-living, randomized, crossover trial. This trial is modeled after previously successful functional food trial at the investigators clinic, consistent with current recommendations to decrease Cardiovascular diseases (CVD) risk and improve circulating lipid profiles. The proposed study will include three treatment phases of 4 weeks each, separated by 4-week washout intervals:
Phase 1: Study diets with placebo (240 ml of 2% milk shake; 50 mg cholesterol).
Phase 2: Study diets with enriched cholesterol (240ml of 2% milk shake; 600 mg cholesterol).
Phase 3: A study diet with plant sterols (240 ml of 2% milk shake;2.0 g/d of plant sterols/240 ml serving; 50 mg cholesterol).
During each treatment period participants will consume their supper time meal along with assigned test product. Consumption of the suppertime meals and the test products will be monitored by a clinical coordinator to ensure compliance. Participants will be asked to fill out a 3-day food diary at the beginning and end of each experimental period.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High cholesterol | Experimental | Other: High cholesterol600 mg cholesterol/day in 240 ml milk shake |
| Plant sterols | Experimental | Other: Plant Sterols2.0 g of plant sterols/day in 240 ml milk shake containing 50 mg cholesterol |
| Placebo | Placebo comparator | Other: Placebo50 mg cholesterol/day in 240 ml of milk shake |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Triglycerides (TG) <3.0 mmol/L
- Body mass index (BMI) between 20 and 30 kg/m2
- Participants must have been breast-fed at least during the first 6 months of their life
Key exclusion criteria (8 listed)
- History of recent (i.e. less than 1 month) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
- History of chronic use of alcohol (>2 drinks/d), smoking, systemic antibodies, corticosteroids, androgens, or phenytoin
- Myocardial infarction, coronary artery bypass, kidney disease, liver disease or other major surgical procedures within the last six months,
- Sitosterolemic patients
- Recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (i.e. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year)
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 |
|---|---|---|
| Plant Sterols | Other | Plant sterols |
| High cholesterol | Other | High cholesterol |
| Placebo | Other | Placebo |
Primary outcome
Change in LDL-cholesterol
Time frame: Day 1,2 & 29,30 of each of the 3 phases. Each phase duration is 1 month
2 secondary outcomes
Change in Cholesterol Absorption
Time frame: Day 26-30 of each of the 3 phases. Each phase duration is 1 month
Change in Cholesterol Synthesis
Time frame: Day 26-30 of each of the 3 phases. Each phase duration is 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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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.
Peter JH Jones, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant Sterols and High cholesterol in people with Hypercholesterolemia and CVD, run by University of Manitoba at 1 site in Canada.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Feb 2016. 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 Canada. 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?
Results are not available in the source record.
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?
Change in LDL-cholesterol (time frame: Day 1,2 & 29,30 of each of the 3 phases. Each phase duration is 1 month). 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 3 Feb 2016.