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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564551
• Other study ID #: UC 21076
• Status: Completed
• Phase: N/A
• First received: November 26, 2007
• Last updated: January 19, 2010
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: January 2010
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Impaired Glucose Tolerance
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Type 2 Diabetes
• Weight Loss

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		12 weeks	No
Secondary	Insulin and glucose response		12 weeks	No
Secondary	Inflammatory Markers		12 weeks	No