Cardiovascular DiseaseMILKNCT01163773
Milk Consumption and the Metabolic Syndrome in Menopausal Women
A study testing MILK in people with Cardiovascular Disease, run by Laval University at 1 site in Canada.
Trial summary
Cardiovascular disease (CVD) represents the first cause of mortality in industrialized countries such as Canada and the United States. In that regard, it is being increasingly recognized that a significant proportion of CVD events may be attributable to the presence of a cluster of metabolic and physiological… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- MILK
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2004to Jun 2006
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Menopausal women (absence of menses > 12 months and FSH > 40 IU/ml), aged between 45 and 65 years
- Presenting 1 or more features of the MetS based on the NCEP-ATP III definition
- Average consumption of milk/dairy products fewer than 2 portions/d (≤ 1.9)
- Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
Who cannot join
- Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
- Subjects taking medications for hyperlipidemia, hypertension or hormonal replacement therapy
- Endocrine disorders
- Smoking
- Food allergies, milk aversion or intolerant to lactose
- 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
Cardiovascular disease (CVD) represents the first cause of mortality in industrialized countries such as Canada and the United States. In that regard, it is being increasingly recognized that a significant proportion of CVD events may be attributable to the presence of a cluster of metabolic and physiological perturbations defined as the metabolic syndrome (MetS). The National Cholesterol Education Program- Adult Treatment Panel III (NCEP-ATP III) has recently proposed a clinical definition to identify individuals with the MetS. This definition is based on the presence of at least three of the following five characteristics: 1- abdominal obesity, 2- hypertriglyceridemia, 3- reduced plasma HDL-C levels, 4- high blood pressure, 5- high fasting blood glucose levels. Recent data have suggested that the MetS based on this definition was associated with a 2 to 5 fold increase in the risk of CVD in men as well as in women. These are alarming figures since it has been suggested that as much as 35 to 45% of female aged > 65 years in the US may have the MetS. It is therefore imperative to develop new preventive strategies that will be efficacious in attenuating the impact of the MetS on the progressing rates of CVD in women. In that context, there is accumulating evidence to suggest that milk and dairy products may beneficially modify several components of the MetS. However, most of the available data to date are based on observational studies or interventional studies with minimal nutritional control. Thus, metabolically controlled studies that document the impact of milk consumption on cardiovascular risk factors associated with the MetS in women defined a priori as having the MetS are utterly lacking.
The purpose of this study was to investigate the impact of milk consumption on features of the MetS in menopausal women presenting one or more features of the MetS.
Read the detailed description
The proposed research will be undertaken as a randomized, cross-over, nutritionally controlled study, with participants being subjected to two 6-week isocaloric diets separated by a 4-week washout period. No stratification was considered since the population recruited will be relatively homogeneous. The experimental diet (designed as 'Milk') will be formulated so that the percentage of daily calories from fat (30%), saturated fat (10%), carbohydrates (55%) and proteins (15%) will conform to most of the dietary recommendations of the American Heart Association and the NCEP for primary prevention of CVD, with the exception of saturated fats (slight excess) and fibers (slight deficit). The cholesterol content of the experimental diet will not exceed 200 mg/day. The only source of dairy products during the experimental phase will be from 2% fat milk. We have chosen to use 2% fat milk because this is the most frequently consumed dairy product in Canada. Two percent fat milk also goes through minimal processing compared to milk or to other dairy products such as yogurt and cheese. Thus, bioactive components in milk are more likely to be retained in the 2% fat milk than in other more extensively processed products. The energy intake from milk will represent 20% of the consumed kcal/day. Based on a reasonable 2000 kcal/day regimen, a 20% intake attributable to 2% fat milk will correspond to 400 day/kcal, which will be derived from a 'daily dose' of 3 portions of milk/day. This dose has been shown to be effective in previous uncontrolled studies. The Control diet will be virtually identical in terms of menus, calories and macronutrient composition, with the exception that milk will be formally excluded from the regimen. The energy intake and changes in macronutrient composition attributable to the milk component in the experimental diet will be compensated in the control diet by modifying the protein, carbohydrate and lipid component of the various recipes.
A 4-week stabilization run-in period will precede the randomization of participants. During this run-in period, participants will be asked and instructed to comply to the NCEP-ATP III prudent diet. They will be asked to maintain their body weight constant during this period. Milk consumption will be adapted during this period to comply to the recommendations of NCEP-ATP III. The washout period between the two experimental diets will last 4 weeks and will also consist of NCEP-ATP III recommended diet. It must be stressed that foods will not be provided during the run-in and wash-out periods. These periods are imposed to minimize the inter- and intra-individual variability before and between the experimental phases.
- Conditions
- Cardiovascular Disease
- Being tested
- MILK
- Keywords
- Cardiovascular disease, Milk, Metabolic syndrome, Blood lipids, Menopausal women
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILKOther
Consumption of the 2 experimental diets
- Milk diet
- Control diet
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma TG levels (MetS criteria)
Measured: At the beginning and the end of the two 6-week diets
HDL-C levels (MetS criteria)
Measured: At the beginning and the end of the two 6-week diets
Systolic and diastolic blood pressure (MetS criteria)
Measured: At the beginning and the end of the two 6-week diets
Fasting blood glucose (MetS criteria)
Measured: At the beginning and the end of the two 6-week diets
Secondary outcomes (5)
Anthropometric measures (waist and hip circumferences)
Measured: At the beginning and the end of the two 6-week diets
LDL and HDL particle size
Measured: At the beginning and the end of the two 6-week diets
Markers of the oxidative stress (i.e. oxLDL and 8-iso-PGF2a levels)
Measured: At the beginning and the end of the two 6-week diets
Markers of a pro-inflammatory state (i.e. C-reactive protein and IL-6 levels)
Measured: At the beginning and the end of the two 6-week diets
Surrogates of cholesterol absorption and synthesis
Measured: At the beginning and the end of the two 6-week diets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startOct 2004
- Primary completionDec 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Dairy Farmers of Canada
- Investigators
- Benoît Lamarche, PhD, Principal investigator, Institute of Nutraceutical and Functional Foods (INAF), Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163773
- Sponsor's protocol ID
- INAF-2004-039
- Acronym
- MILK
- Status last verified
- Jul 2010
- First submitted
- 14 Jul 2010
- Last updated
- 16 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk Consumption and the Metabolic Syndrome in Menopausal Women
- ClinicalTrials.gov ID
- NCT01163773
- Acronym / sponsor ID
- MILK / INAF-2004-039
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease, Milk, Metabolic syndrome, Blood lipids, Menopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Dairy Farmers of Canada
- Study start
- Oct 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 16 Jul 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.
Cardiovascular disease (CVD) represents the first cause of mortality in industrialized countries such as Canada and the United States. In that regard, it is being increasingly recognized that a significant proportion of CVD events may be attributable to the presence of a cluster of metabolic and physiological perturbations defined as the metabolic syndrome (MetS). The National Cholesterol Education Program- Adult Treatment Panel III (NCEP-ATP III) has recently proposed a clinical definition to identify individuals with the MetS. This definition is based on the presence of at least three of the following five characteristics: 1- abdominal obesity, 2- hypertriglyceridemia, 3- reduced plasma HDL-C levels, 4- high blood pressure, 5- high fasting blood glucose levels. Recent data have suggested that the MetS based on this definition was associated with a 2 to 5 fold increase in the risk of CVD in men as well as in women. These are alarming figures since it has been suggested that as much as 35 to 45% of female aged > 65 years in the US may have the MetS. It is therefore imperative to develop new preventive strategies that will be efficacious in attenuating the impact of the MetS on the progressing rates of CVD in women. In that context, there is accumulating evidence to suggest that milk and dairy products may beneficially modify several components of the MetS. However, most of the available data to date are based on observational studies or interventional studies with minimal nutritional control. Thus, metabolically controlled studies that document the impact of milk consumption on cardiovascular risk factors associated with the MetS in women defined a priori as having the MetS are utterly lacking.
The purpose of this study was to investigate the impact of milk consumption on features of the MetS in menopausal women presenting one or more features of the MetS.
Detailed description
The proposed research will be undertaken as a randomized, cross-over, nutritionally controlled study, with participants being subjected to two 6-week isocaloric diets separated by a 4-week washout period. No stratification was considered since the population recruited will be relatively homogeneous. The experimental diet (designed as 'Milk') will be formulated so that the percentage of daily calories from fat (30%), saturated fat (10%), carbohydrates (55%) and proteins (15%) will conform to most of the dietary recommendations of the American Heart Association and the NCEP for primary prevention of CVD, with the exception of saturated fats (slight excess) and fibers (slight deficit). The cholesterol content of the experimental diet will not exceed 200 mg/day. The only source of dairy products during the experimental phase will be from 2% fat milk. We have chosen to use 2% fat milk because this is the most frequently consumed dairy product in Canada. Two percent fat milk also goes through minimal processing compared to milk or to other dairy products such as yogurt and cheese. Thus, bioactive components in milk are more likely to be retained in the 2% fat milk than in other more extensively processed products. The energy intake from milk will represent 20% of the consumed kcal/day. Based on a reasonable 2000 kcal/day regimen, a 20% intake attributable to 2% fat milk will correspond to 400 day/kcal, which will be derived from a 'daily dose' of 3 portions of milk/day. This dose has been shown to be effective in previous uncontrolled studies. The Control diet will be virtually identical in terms of menus, calories and macronutrient composition, with the exception that milk will be formally excluded from the regimen. The energy intake and changes in macronutrient composition attributable to the milk component in the experimental diet will be compensated in the control diet by modifying the protein, carbohydrate and lipid component of the various recipes.
A 4-week stabilization run-in period will precede the randomization of participants. During this run-in period, participants will be asked and instructed to comply to the NCEP-ATP III prudent diet. They will be asked to maintain their body weight constant during this period. Milk consumption will be adapted during this period to comply to the recommendations of NCEP-ATP III. The washout period between the two experimental diets will last 4 weeks and will also consist of NCEP-ATP III recommended diet. It must be stressed that foods will not be provided during the run-in and wash-out periods. These periods are imposed to minimize the inter- and intra-individual variability before and between the experimental phases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Menopausal women (absence of menses > 12 months and FSH > 40 IU/ml), aged between 45 and 65 years
- Presenting 1 or more features of the MetS based on the NCEP-ATP III definition
- Average consumption of milk/dairy products fewer than 2 portions/d (≤ 1.9)
- 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, hypertension or hormonal replacement therapy
- Endocrine disorders
- Smoking
- Food allergies, milk aversion or intolerant to lactose
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 |
|---|---|---|
| MILKConsumption of the 2 experimental diets 1. Milk diet 2. Control diet | Other | – |
Primary outcome
Plasma TG levels (MetS criteria)
Time frame: At the beginning and the end of the two 6-week diets
HDL-C levels (MetS criteria)
Time frame: At the beginning and the end of the two 6-week diets
Systolic and diastolic blood pressure (MetS criteria)
Time frame: At the beginning and the end of the two 6-week diets
Fasting blood glucose (MetS criteria)
Time frame: At the beginning and the end of the two 6-week diets
5 secondary outcomes
Anthropometric measures (waist and hip circumferences)
Time frame: At the beginning and the end of the two 6-week diets
LDL and HDL particle size
Time frame: At the beginning and the end of the two 6-week diets
Markers of the oxidative stress (i.e. oxLDL and 8-iso-PGF2a levels)
Time frame: At the beginning and the end of the two 6-week diets
Markers of a pro-inflammatory state (i.e. C-reactive protein and IL-6 levels)
Time frame: At the beginning and the end of the two 6-week diets
Surrogates of cholesterol absorption and synthesis
Time frame: At the beginning and the end of the two 6-week diets
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 16 Jul 2010.
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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.
Benoît Lamarche, PhD principal investigator
Institute of Nutraceutical and Functional Foods (INAF), 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 MILK 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 4 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 16 Jul 2010. 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. 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?
Plasma TG levels (MetS criteria) (time frame: At the beginning and the end of the two 6-week diets). The study lists 4 primary outcomes in all. 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 16 Jul 2010.