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Milk Consumption and the Metabolic Syndrome in Menopausal Women (MILK)

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ClinicalTrials.gov Identifier: NCT01163773
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : July 16, 2010
Information provided by:

Study Description
Brief 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 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.

Condition or disease Intervention/treatment
Cardiovascular Disease Other: MILK

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Milk Consumption and the Metabolic Syndrome in Menopausal Women
Study Start Date : October 2004
Primary Completion Date : December 2005
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Other: MILK

    Consumption of the 2 experimental diets

    1. Milk diet
    2. Control diet

Outcome Measures

Primary Outcome Measures :
  1. Plasma TG levels (MetS criteria) [ Time Frame: At the beginning and the end of the two 6-week diets ]
  2. HDL-C levels (MetS criteria) [ Time Frame: At the beginning and the end of the two 6-week diets ]
  3. Systolic and diastolic blood pressure (MetS criteria) [ Time Frame: At the beginning and the end of the two 6-week diets ]
  4. Fasting blood glucose (MetS criteria) [ Time Frame: At the beginning and the end of the two 6-week diets ]

Secondary Outcome Measures :
  1. Anthropometric measures (waist and hip circumferences) [ Time Frame: At the beginning and the end of the two 6-week diets ]
  2. LDL and HDL particle size [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: At the beginning and the end of the two 6-week diets ]
  5. Surrogates of cholesterol absorption and synthesis [ Time Frame: At the beginning and the end of the two 6-week diets ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163773

Institute of Nutraceutical and Functional Foods (INAF), Laval University
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Dairy Farmers of Canada
Principal Investigator: Benoît Lamarche, PhD Institute of Nutraceutical and Functional Foods (INAF), Laval University
More Information

Responsible Party: Benoît Lamarche, PhD, Institute of Nutraceutical and Functional Foods (INAF), Laval University
ClinicalTrials.gov Identifier: NCT01163773     History of Changes
Other Study ID Numbers: INAF-2004-039
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: July 16, 2010
Last Verified: July 2010

Keywords provided by Laval University:
Cardiovascular disease
Metabolic syndrome
Blood lipids
Menopausal women

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases