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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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.

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

    1. Milk diet
    2. Control diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma TG levels (MetS criteria)

    Measured: At the beginning and the end of the two 6-week diets

  2. HDL-C levels (MetS criteria)

    Measured: At the beginning and the end of the two 6-week diets

  3. Systolic and diastolic blood pressure (MetS criteria)

    Measured: At the beginning and the end of the two 6-week diets

  4. Fasting blood glucose (MetS criteria)

    Measured: At the beginning and the end of the two 6-week diets

Secondary outcomes (5)
  1. Anthropometric measures (waist and hip circumferences)

    Measured: At the beginning and the end of the two 6-week diets

  2. LDL and HDL particle size

    Measured: At the beginning and the end of the two 6-week diets

  3. 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

  4. 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

  5. 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.

  1. First posted16 Jul 2010 (estimated)
  2. Study startOct 2004
  3. Primary completionDec 2005
  4. Study completionJun 2006

Resources

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)
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

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.

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