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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Type 2 Diabetes; Impaired Glucose Tolerance
• Intervention / Treatment: Behavioral: High dairy and calcium intake; Behavioral: Usual intake

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2; 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; 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.; Other Names: Jamieson Mega Cal™ Chewable Calcium (350 mg) tablet
Placebo Comparator: 1; 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; Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight loss	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: November 26, 2007
• First Submitted That Met QC Criteria: November 26, 2007
• First Posted (Estimate): November 28, 2007

Study Record Updates

• Last Update Posted (Estimate): January 21, 2010
• Last Update Submitted That Met QC Criteria: January 19, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Prediabetes; Type 2 diabetes; Weight loss; Calcium; Insulin resistance syndrome; Milk products
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease; Diabetes Mellitus; Body Weight; Hyperinsulinism; Body Weight Changes; Hyperglycemia; Diabetes Mellitus, Type 2; Syndrome; Metabolic Syndrome; Weight Loss; Glucose Intolerance; Insulin Resistance; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium; Calcium, Dietary
• Other Study ID Numbers: UC 21076