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

University of Calgary

Status: Completed

Conditions: Impaired Glucose Tolerance; Type 2 Diabetes; Metabolic Syndrome

Treatments: Behavioral: Usual intake; Behavioral: High dairy and calcium intake

Study type: Interventional

Funder types: Other

Identifiers

NCT00564551

UC 21076

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

49 participants in 2 patient groups, including a placebo group

2

Active Comparator group

Description:

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.

Treatment:

Behavioral: High dairy and calcium intake

1

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Usual intake