HypercholesterolemiaNCT01566305
Effects of Buttermilk on Serum LDL Cholesterol Concentrations
A study testing Buttermilk without added egg-yolk, Buttermilk with added egg yolk and Skimmed milk with added egg-yolk in people with Hypercholesterolemia and Buttermilk, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale and objective: Based on the results of a pilot study, the objective of the present study is to evaluate whether buttermilk lower serum LDL cholesterol concentrations and can prevent the serum LDL cholesterol raising effects of eggs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia, Buttermilk, Dietary Modification
- What is being tested?
- Buttermilk without added egg-yolk, Buttermilk with added egg yolk and Skimmed milk with added egg-yolk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2010to 1 Dec 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years
- Fasting serum total cholesterol between 5.5 - 8.0 mmol/l
- Fasting plasma glucose < 7.0 mmol/l
- BMI between 25-30 kg/m2
- non-smoking
- Willingness to abstain for the duration of the study from egg consumption
Who cannot join
- unstable body weight (weight gain or loss >3 kg in the past 3 months)
- allergic for eggs or egg-rich products
- allergic or intolerant for cow-milk (lactose) based products
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- use of medication or a diet known to affect serum lipid or glucose metabolism - active cardiovascular disease (for instance congestive heart failure) or recent (<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
- not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
Show all 13Show fewer
- men: consumption of >21 alcohol consumptions a week
- women: consumption of >14 alcohol consumptions a week
- abuse of drugs
- pregnant or breastfeeding women
- participation in another biomedical study within 1 month prior to the screening visit
- having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study
- impossible or difficult venipuncture as evidenced during the screening visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Buttermilk With or Without Lutein-enriched Egg Yolk on the Serum LDL Cholesterol Concentration of Slightly Hypercholesterolaemic Volunteers
Rationale and objective:
Based on the results of a pilot study, the objective of the present study is to evaluate whether buttermilk lower serum LDL cholesterol concentrations and can prevent the serum LDL cholesterol raising effects of eggs.
Read more
Study Design:
The study has a randomized placebo-controlled factorial 2x2 design. The total study duration is 14 weeks, consisting of a 2 weeks run-in period and a 12 weeks experimental period. Subjects will be stratified for age, gender and BMI over the experimental groups.
Study population:
One hundred and eight healthy male and female subjects, aged 18-70 years, with slightly elevated serum total cholesterol concentrations (5.5-8.0 mmol/l).
Intervention:
During the entire study period, volunteers are instructed to consume a diet according to the Dutch dietary guidelines (35 en% fat (10 en% saturated fat), 50-55 en% carbohydrates). During the two weeks run-in period all subjects will drink daily at lunch 100 mL skimmed milk. During the 12 weeks experimental period, a first group of subjects will continue drinking the skimmed milk (control group), while a second group will consume a low-fat buttermilk, a third group skimmed milk enriched with egg-yolk, and a fourth group egg-yolk incorporated into a low-fat buttermilk based beverage. The egg-yolk will be enriched in lutein. Whole egg consumption (others than provided by us) is not allowed during the entire study.
Main study parameters/endpoints:
Measurements will be performed during the run-in period (days 0, 11 and 14) and during the experimental period (days 56, 95 and 98). The main effects (egg-yolk and buttermilk consumption) will be calculated as the absolute differences between values obtained at the end of the experimental (average days 95 and 98) and run-in (average days 11 and 14) periods. The primary endpoint is the change in serum LDL cholesterol concentrations. Secondary endpoints are changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and hsCRP concentrations.
- Being tested
- Buttermilk without added egg-yolk, Buttermilk with added egg yolk, Skimmed milk with added egg-yolk, Skimmed milk without added egg yolk
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buttermilk without added egg-yolkDietary supplement
Buttermilk without added egg-yolk
Buttermilk with added egg yolkDietary supplement
Buttermilk with added egg yolk
Skimmed milk with added egg-yolkDietary supplement
Skimmed milk with added egg-yolk
Skimmed milk without added egg yolkDietary supplement
Skimmed milk without added egg yolk
| Study group | Role | What they receive |
|---|---|---|
| Buttermilk with added egg yolk | Experimental | Not described Receives: Dietary Supplement: Buttermilk with added egg yolk |
| Buttermilk without added egg-yolk | Experimental | Not described Receives: Dietary Supplement: Buttermilk without added egg-yolk |
| Skimmed milk with added egg-yolk | Experimental | Not described Receives: Dietary Supplement: Skimmed milk with added egg-yolk |
| Skimmed milk without added egg yolk | Placebo comparator | Not described Receives: Dietary Supplement: Skimmed milk without added egg yolk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum LDL cholesterol concentrations
Measured: LDL cholesterol will be measured at day 0, 11, 14, 56, 95 and 98 during the study
Secondary outcomes (1)
Changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and hsCRP concentrations
Measured: Serum total and HDL cholesterol, triacylglycerol, apoA-I and ApoB will be measured at day 0, 11, 14, 56, 95 and 98 during the study. hsCRP concentrations will be measured at day 11, 14, 95 and 98.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startOct 2010
- Primary completion1 May 2012
- Study completion1 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jogchum Plat, Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566305
- Sponsor's protocol ID
- NL33461.068.10
- Status last verified
- Sep 2018
- First submitted
- 27 Mar 2012
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Severins N, Mensink RP, Plat J. Effects of lutein-enriched egg yolk in buttermilk or skimmed milk on serum lipids & lipoproteins of mildly hypercholesterolemic subjects. Nutr Metab Cardiovasc Dis. 2015 Feb;25(2):210-7. doi: 10.1016/j.numecd.2014.10.003. Epub 2014 Oct 13.
PubMed 25456153
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Buttermilk With or Without Lutein-enriched Egg Yolk on the Serum LDL Cholesterol Concentration of Slightly Hypercholesterolaemic Volunteers
- ClinicalTrials.gov ID
- NCT01566305
- Acronym / sponsor ID
- NL33461.068.10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- 1 May 2012 (actual)
- Study completion
- 1 Dec 2012 (actual)
- First posted
- 29 Mar 2012 (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 and objective:
Based on the results of a pilot study, the objective of the present study is to evaluate whether buttermilk lower serum LDL cholesterol concentrations and can prevent the serum LDL cholesterol raising effects of eggs.
Study Design:
The study has a randomized placebo-controlled factorial 2x2 design. The total study duration is 14 weeks, consisting of a 2 weeks run-in period and a 12 weeks experimental period. Subjects will be stratified for age, gender and BMI over the experimental groups.
Study population:
One hundred and eight healthy male and female subjects, aged 18-70 years, with slightly elevated serum total cholesterol concentrations (5.5-8.0 mmol/l).
Intervention:
During the entire study period, volunteers are instructed to consume a diet according to the Dutch dietary guidelines (35 en% fat (10 en% saturated fat), 50-55 en% carbohydrates). During the two weeks run-in period all subjects will drink daily at lunch 100 mL skimmed milk. During the 12 weeks experimental period, a first group of subjects will continue drinking the skimmed milk (control group), while a second group will consume a low-fat buttermilk, a third group skimmed milk enriched with egg-yolk, and a fourth group egg-yolk incorporated into a low-fat buttermilk based beverage. The egg-yolk will be enriched in lutein. Whole egg consumption (others than provided by us) is not allowed during the entire study.
Main study parameters/endpoints:
Measurements will be performed during the run-in period (days 0, 11 and 14) and during the experimental period (days 56, 95 and 98). The main effects (egg-yolk and buttermilk consumption) will be calculated as the absolute differences between values obtained at the end of the experimental (average days 95 and 98) and run-in (average days 11 and 14) periods. The primary endpoint is the change in serum LDL cholesterol concentrations. Secondary endpoints are changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and hsCRP concentrations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Buttermilk with added egg yolk | Experimental | Dietary Supplement: Buttermilk with added egg yolk |
| Buttermilk without added egg-yolk | Experimental | Dietary Supplement: Buttermilk without added egg-yolk |
| Skimmed milk with added egg-yolk | Experimental | Dietary Supplement: Skimmed milk with added egg-yolk |
| Skimmed milk without added egg yolk | Placebo comparator | Dietary Supplement: Skimmed milk without added egg yolk |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 70 years
- Fasting serum total cholesterol between 5.5 - 8.0 mmol/l
- Fasting plasma glucose < 7.0 mmol/l
- BMI between 25-30 kg/m2
- non-smoking
Key exclusion criteria (13 listed)
- unstable body weight (weight gain or loss >3 kg in the past 3 months)
- allergic for eggs or egg-rich products
- allergic or intolerant for cow-milk (lactose) based products
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- use of medication or a diet known to affect serum lipid or glucose metabolism - active cardiovascular disease (for instance congestive heart failure) or recent (<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
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 |
|---|---|---|
| Buttermilk without added egg-yolkButtermilk without added egg-yolk | Dietary supplement | Buttermilk without added egg-yolk |
| Buttermilk with added egg yolkButtermilk with added egg yolk | Dietary supplement | Buttermilk with added egg yolk |
| Skimmed milk with added egg-yolkSkimmed milk with added egg-yolk | Dietary supplement | Skimmed milk with added egg-yolk |
| Skimmed milk without added egg yolkSkimmed milk without added egg yolk | Dietary supplement | Skimmed milk without added egg yolk |
Primary outcome
Change in serum LDL cholesterol concentrations
Time frame: LDL cholesterol will be measured at day 0, 11, 14, 56, 95 and 98 during the study
1 secondary outcome
Changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and hsCRP concentrations
Time frame: Serum total and HDL cholesterol, triacylglycerol, apoA-I and ApoB will be measured at day 0, 11, 14, 56, 95 and 98 during the study. hsCRP concentrations will be measured at day 11, 14, 95 and 98.
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 6 Sep 2018.
- Derived from this study: PubMed 25456153Severins N, Mensink RP, Plat J. Effects of lutein-enriched egg yolk in buttermilk or skimmed milk on serum lipids & lipoproteins of mildly hypercholesterolemic subjects. Nutr Metab Cardiovasc Dis. 2015 Feb;25(2):210-7. doi: 10.1016/j.numecd.2014.10.003. Epub 2014 Oct 13.
- Related InfoLink provided by the sponsor.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
Jogchum Plat, Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buttermilk without added egg-yolk, Buttermilk with added egg yolk and Skimmed milk with added egg-yolk in people with Hypercholesterolemia and Buttermilk, run by Maastricht University Medical Center 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 6 inclusion and 13 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 6 Sep 2018. 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?
Change in serum LDL cholesterol concentrations (time frame: LDL cholesterol will be measured at day 0, 11, 14, 56, 95 and 98 during the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01566305, which also lists 1 linked publication.
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 6 Sep 2018.