Effect of Increased Intake of Low Fat Dairy Products on Weight Loss and Insulin Resistance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of High Milk Product and Calcium Intake During Weight Loss on Markers of Insulin Resistance

Conditions
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Impaired Glucose Tolerance, Type 2 Diabetes, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: High dairy and calcium intake
* Behavioral: Usual intake


Participation Criteria
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Eligibility Criteria
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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: Hypertriglyceridemia (> 1.70 mmol/L) Low high-density lipoprotein (HDL) cholesterol (< 1.04 mmol/L in men and < 1.30 mmol/L in women) High blood pressure (> 130/85 mm Hg) 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>High dairy intake and calcium supplement. High intake of low-fat milk product intake (3-4 servings per day) plus one 350 mg calcium supplement per day during 500 kcal/day deficit diet. | Behavioral: High dairy and calcium intake<br>* High intake of low-fat milk product intake (3-4 servings per day) plus one 350 mg calcium supplement per day during 500 kcal/day deficit diet.<br>* Other names: Jamieson Mega Cal™ Chewable Calcium (350 mg) tablet;|
| Placebo Comparator: 1<br>Usual diet of low dairy and calcium intake. Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet. | Behavioral: Usual intake<br>* Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin and glucose response |  | 12 weeks | 
| Inflammatory Markers |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetes, Type 2 diabetes, Metabolic syndrome, Insulin resistance syndrome, Weight loss, Milk products, Calcium