Clinical trial NCT00564551: Effect of Increased Intake of Low Fat Dairy Products on Weight Loss and Insulin Resistance
Official title: Impact of High Milk Product and Calcium Intake During Weight Loss on Markers of Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Glucose Tolerance
Type 2 Diabetes
Metabolic Syndrome
Keywords: Prediabetes
Type 2 diabetes
Metabolic syndrome
Insulin resistance syndrome
Weight loss
Milk products
Calcium
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2007-11-28
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if increased intake of low-fat milk products and calcium as part of a calorie restricted diet helps achieve a healthier body weight and body composition and decrease blood glucose levels in people with insulin resistance or type 2 diabetes.

Detailed description: Obesity can cause many health problems as it is linked to several chronic diseases including type 2 diabetes. We know that individuals who are overweight or obese, and have impaired glucose tolerance or insulin resistance, have a good chance of developing type 2 diabetes. Research tells us that the risk of developing type 2 diabetes can be decreased by losing weight and making dietary changes. A promising area of study involves using low-fat milk products and calcium to prevent and/or control obesity and diabetes. This study is important because it will determine if including low-fat milk products in weight reducing diets can enhance weight loss, improve fat loss and decrease levels of blood glucose and insulin in individuals with impaired glucose tolerance or type 2 diabetes not treated with medication. This information is directly applicable to treating diseases such as obesity, type 2 diabetes and heart disease.

Eligibility criteria: Inclusion Criteria:

* Overweight and obese (BMI of 27 to 37 kg/m2)
* Impaired glucose tolerance (fasting blood glucose \>5.6 mmol/L) or
* Type 2 diabetes treated with diet and exercise alone (no medications)
* One or more of the following criteria for metabolic syndrome:

  1. Hypertriglyceridemia (\> 1.70 mmol/L)
  2. Low high-density lipoprotein (HDL) cholesterol (\< 1.04 mmol/L in men and \< 1.30 mmol/L in women)
  3. High blood pressure (\> 130/85 mm Hg)
  4. High waist circumference ( \> 94 cm in men, \> 80 cm in women)
* Weight stable and no changes in exercise in past 3 months

Exclusion Criteria:

* Type 1 diabetes
* Type 2 diabetes treated with oral hypoglycemic agents or insulin
* HbA1c \> 8%
* myocardial infarction or have undergone a cardiovascular intervention within the past three months
* Subjects taking fibrate or statins who have had a dose change within the 8 weeks prior to randomization
* Liver or pancreas disease
* Major gastrointestinal surgeries
* Pregnant or lactating
* Exhibit alcohol or drug dependence
* Taking drugs influencing appetite
* Have a milk allergy or lactose intolerance
* Following a diet or exercise regime designed for weight loss
* Have a body weight greater than 350 lb (weight limit for DEXA instrument)
* Chronic use of bulk laxatives, antacids or calcium supplements

Primary outcomes:
measure: Weight loss
timeFrame: 12 weeks
Secondary outcomes:
measure: Insulin and glucose response
timeFrame: 12 weeks
measure: Inflammatory Markers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research
state: Alberta
Study officials:
affiliation: University of Calgary
name: Raylene A. Reimer, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: