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

NCT ID: NCT00564551

Last Updated: 2010-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-10-31

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.

Conditions

Impaired Glucose Tolerance; Type 2 Diabetes; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

High dairy and calcium intake

Intervention Type: BEHAVIORAL

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.

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.

Group Type: PLACEBO_COMPARATOR

Usual intake

Intervention Type: BEHAVIORAL

Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

Jamieson Mega Cal™ Chewable Calcium (350 mg) tablet

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

University of Calgary

Principal Investigators

Raylene A. Reimer, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

UC 21076

Identifier Type: -

Identifier Source: org_study_id