Cardiovascular DiseaseBMILKNCT01248026
Impact of Buttermilk on Cholesterol Concentration and Homeostasis
A study testing Buttermilk in people with Cardiovascular Disease, run by Laval University at 1 site in Canada.
Trial summary
The role of low-density lipoprotein cholesterol (LDL-C) in the pathogenesis of cardiovascular disease (CVD) and the clinical benefit of lowering LDL-C in high-risk patients have both been well established. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Buttermilk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Dec 2011
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women aged between 18 and 65 years
- For pre-menopausal women: regular menstrual cycle for the last 3 months (25- 35 days), using or not contraceptive agents
- LDL-Cholesterol concentration between 3.2 and 4.5 mmol/L
- A 10-yr calculated Framingham risk below 10%.
- Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
- Smoking or not
Who cannot join
- Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
- Subjects taking medications for hyperlipidemia or hypertension
- Endocrine disorders
- Body mass index > 35 kg/m2
- Food allergies
- Men and women with extreme nutritional habits such as vegetarism or alcohol consumption > 2 drinks/day
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Québec, Quebec, G1V 0A6
About this study
The role of low-density lipoprotein cholesterol (LDL-C) in the pathogenesis of cardiovascular disease (CVD) and the clinical benefit of lowering LDL-C in high-risk patients have both been well established. The key contribution of the intestine to whole body cholesterol homeostasis and thus to regulating plasma cholesterol concentrations has also been recognized over the last years. It is now clear that cholesterol homeostasis and hence plasma LDL-C concentrations are maintained by a fine-tuned balance between intestinal cholesterol absorption and endogenous cholesterol synthesis.
Cholesterol is a highly hydrophobic molecule and for that reason, its absorption is almost entirely dependent on its solubilizing capacity in bile acid micelles within the intestine. Recent in vitro studies from our laboratory have shown that buttermilk, a unique by-product of butter manufacturing resulting from the churning of cream, has a strong inhibitory effect on cholesterol micelle solubility. This phenomenon is likely due to the presence of unique milk fat globule membrane (MFGM) fragments present in buttermilk that are produced during the manufacturing of dairy cream into butter. Most of the work done so far on the subject has focused on phospholipids purified from MFGM, while overlooking the complex and entire MFGM mixture of bioactive proteins and polar lipids found in buttermilk. To the best of our knowledge, no study has yet documented the impact of whole buttermilk on plasma cholesterol concentration in human.
The general objective of this research project is to investigate for the first time the impact of buttermilk on plasma cholesterol and other risk factors for CVD in humans. More specifically, we propose to investigate the impact of buttermilk consumption on plasma LDL-C and other CVD risk factors as well as on plasma surrogates of cholesterol absorption and synthesis.
Read the detailed description
The proposed research will be undertaken as a double-blind randomized cross-over study with participants being subjected to 2 consecutive treatments of 4 weeks each, in random order, during which they will consume 45g of buttermilk and a macro- and micronutrient matching placebo. The treatments will be different in their content of MFGM (present in buttermilk, absent in placebo). Buttermilk and placebo will be fully characterized and formulated in ready-to-use pouches, each pouch containing 22.5 g of artificially flavored products that will have to be mixed in a fixed amount of water for consumption. Participants will have to consume two pouches every day. Based on a 2500 kcal/day regimen, we have calculated that these placebo and buttermilk formulation will contribute to approximately 200 kcal (from 5% and 10%) of the daily energy intake of participants, who will be asked to maintain other aspects of their nutritional habits constant throughout the study.
Fluctuations in female hormones have been shown to influence metabolic variables. For that reason, outcomes at the end of each dietary phase will be measured during the follicular phase of menstrual cycle (day 3 to day 9) in pre-menopausal women. This is another argument for using a 4-wk intervention, which essentially corresponds to the mean duration of the menstrual cycle of most women. Pre-menopausal women will start the first diet during the first week of their menstrual cycle.
- Conditions
- Cardiovascular Disease
- Being tested
- Buttermilk
- Keywords
- Cardiovascular disease, Buttermilk, Blood lipids, Cholesterol absorption, Cholesterol synthesis
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButtermilkOther
Also called chocolat buttermilk ready-to-use pouches
Consumption of the 2 experimental periods
- buttermilk (45 g/d)
- placebo (45 g/d,)
| Study group | Role | What they receive |
|---|---|---|
| Buttermilk | Experimental | Not described Receives: Other: Buttermilk |
| Placebo | Placebo comparator | Not described Receives: Other: Buttermilk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma LDL-Cholesterol concentrations
Measured: At the beginning of the study and the end of the 2 four-week periods
Secondary outcomes (4)
Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides)
Measured: At the beginning of the study and the end of the 2 four-week periods
Change in blood pressure
Measured: At the beginning of the study and the end of the 2 four-week periods
Change in surrogates of cholesterol absorption and synthesis
Measured: At the beginning of the study and the end of the 2 four-week periods
Change in anthropometric measures (waist and hip circumferences)
Measured: At the beginning of the study and the end of the 2 four-week periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionDec 2011
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 Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Responsible party
- Principal investigator, Benoit Lamarche, Laval University
- Investigators
- Patrick Couture, MD, FRCP (C, PhD), Study director, Faculty of Medicine, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248026
- Sponsor's protocol ID
- INAF-2010-035
- Acronym
- BMILK
- Status last verified
- Jan 2013
- First submitted
- 18 Nov 2010
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Conway V, Couture P, Richard C, Gauthier SF, Pouliot Y, Lamarche B. Impact of buttermilk consumption on plasma lipids and surrogate markers of cholesterol homeostasis in men and women. Nutr Metab Cardiovasc Dis. 2013 Dec;23(12):1255-62. doi: 10.1016/j.numecd.2013.03.003. Epub 2013 Jun 17.
PubMed 23786821
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Buttermilk on Cholesterol Concentration and Homeostasis
- ClinicalTrials.gov ID
- NCT01248026
- Acronym / sponsor ID
- BMILK / INAF-2010-035
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease, Buttermilk, Blood lipids, Cholesterol absorption, Cholesterol synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Nov 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.
The role of low-density lipoprotein cholesterol (LDL-C) in the pathogenesis of cardiovascular disease (CVD) and the clinical benefit of lowering LDL-C in high-risk patients have both been well established. The key contribution of the intestine to whole body cholesterol homeostasis and thus to regulating plasma cholesterol concentrations has also been recognized over the last years. It is now clear that cholesterol homeostasis and hence plasma LDL-C concentrations are maintained by a fine-tuned balance between intestinal cholesterol absorption and endogenous cholesterol synthesis.
Cholesterol is a highly hydrophobic molecule and for that reason, its absorption is almost entirely dependent on its solubilizing capacity in bile acid micelles within the intestine. Recent in vitro studies from our laboratory have shown that buttermilk, a unique by-product of butter manufacturing resulting from the churning of cream, has a strong inhibitory effect on cholesterol micelle solubility. This phenomenon is likely due to the presence of unique milk fat globule membrane (MFGM) fragments present in buttermilk that are produced during the manufacturing of dairy cream into butter. Most of the work done so far on the subject has focused on phospholipids purified from MFGM, while overlooking the complex and entire MFGM mixture of bioactive proteins and polar lipids found in buttermilk. To the best of our knowledge, no study has yet documented the impact of whole buttermilk on plasma cholesterol concentration in human.
The general objective of this research project is to investigate for the first time the impact of buttermilk on plasma cholesterol and other risk factors for CVD in humans. More specifically, we propose to investigate the impact of buttermilk consumption on plasma LDL-C and other CVD risk factors as well as on plasma surrogates of cholesterol absorption and synthesis.
Detailed description
The proposed research will be undertaken as a double-blind randomized cross-over study with participants being subjected to 2 consecutive treatments of 4 weeks each, in random order, during which they will consume 45g of buttermilk and a macro- and micronutrient matching placebo. The treatments will be different in their content of MFGM (present in buttermilk, absent in placebo). Buttermilk and placebo will be fully characterized and formulated in ready-to-use pouches, each pouch containing 22.5 g of artificially flavored products that will have to be mixed in a fixed amount of water for consumption. Participants will have to consume two pouches every day. Based on a 2500 kcal/day regimen, we have calculated that these placebo and buttermilk formulation will contribute to approximately 200 kcal (from 5% and 10%) of the daily energy intake of participants, who will be asked to maintain other aspects of their nutritional habits constant throughout the study.
Fluctuations in female hormones have been shown to influence metabolic variables. For that reason, outcomes at the end of each dietary phase will be measured during the follicular phase of menstrual cycle (day 3 to day 9) in pre-menopausal women. This is another argument for using a 4-wk intervention, which essentially corresponds to the mean duration of the menstrual cycle of most women. Pre-menopausal women will start the first diet during the first week of their menstrual cycle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buttermilk | Experimental | Other: Buttermilk |
| Placebo | Placebo comparator | Other: Buttermilk |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy men and women aged between 18 and 65 years
- For pre-menopausal women: regular menstrual cycle for the last 3 months (25- 35 days), using or not contraceptive agents
- LDL-Cholesterol concentration between 3.2 and 4.5 mmol/L
- A 10-yr calculated Framingham risk below 10%.
- Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
Key exclusion criteria (6 listed)
- Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
- Subjects taking medications for hyperlipidemia or hypertension
- Endocrine disorders
- Body mass index > 35 kg/m2
- Food allergies
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 |
|---|---|---|
| ButtermilkAlso: chocolat buttermilk ready-to-use pouchesConsumption of the 2 experimental periods 1. buttermilk (45 g/d) 2. placebo (45 g/d,) | Other | Buttermilk, Placebo |
Primary outcome
Change in plasma LDL-Cholesterol concentrations
Time frame: At the beginning of the study and the end of the 2 four-week periods
4 secondary outcomes
Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides)
Time frame: At the beginning of the study and the end of the 2 four-week periods
Change in blood pressure
Time frame: At the beginning of the study and the end of the 2 four-week periods
Change in surrogates of cholesterol absorption and synthesis
Time frame: At the beginning of the study and the end of the 2 four-week periods
Change in anthropometric measures (waist and hip circumferences)
Time frame: At the beginning of the study and the end of the 2 four-week periods
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 23 Jan 2013.
- Derived from this study: PubMed 23786821Conway V, Couture P, Richard C, Gauthier SF, Pouliot Y, Lamarche B. Impact of buttermilk consumption on plasma lipids and surrogate markers of cholesterol homeostasis in men and women. Nutr Metab Cardiovasc Dis. 2013 Dec;23(12):1255-62. doi: 10.1016/j.numecd.2013.03.003. Epub 2013 Jun 17.
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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.
Patrick Couture, MD, FRCP (C, PhD) study director
Faculty of Medicine, Laval 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 in people with Cardiovascular Disease, run by Laval University 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 6 inclusion and 6 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 23 Jan 2013. 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?
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 plasma LDL-Cholesterol concentrations (time frame: At the beginning of the study and the end of the 2 four-week periods). 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 NCT01248026, 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 23 Jan 2013.