Milk Consumption and the Metabolic Syndrome in Menopausal Women

NCT01163773 | Completed

• 1 other identifier: INAF-2004-039
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular disease; Milk; Metabolic syndrome; Blood lipids; Menopausal women

Outcome Measures

Primary Outcomes (4)

• Plasma TG levels (MetS criteria)

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

• HDL-C levels (MetS criteria)

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

• Systolic and diastolic blood pressure (MetS criteria)

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

• Fasting blood glucose (MetS criteria)

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

Secondary Outcomes (5)

• Anthropometric measures (waist and hip circumferences)

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

• LDL and HDL particle size

  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)

  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)

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

• Surrogates of cholesterol absorption and synthesis

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

Interventions

MILK OTHER

Consumption of the 2 experimental diets 1. Milk diet 2. Control diet

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Dairy Farmers of Canada: collaborator

Study Sites (1)

Institute of Nutraceutical and Functional Foods (INAF), Laval University

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Metabolic Syndrome

Interventions

Milk

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Benoît Lamarche, PhD

  Institute of Nutraceutical and Functional Foods (INAF), Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 16, 2010
• Study Start: October 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: June 1, 2006
• Last Updated: July 16, 2010

Record last verified: 2010-07

Locations

CA (1)