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Completed

NCT Number: NCT00564551

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Calgary, Alberta, T2N 1N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High dairy and calcium intake

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.

Other names: Jamieson Mega Cal™ Chewable Calcium (350 mg) tablet

Usual intake

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

Primary outcomes

  1. Weight loss

    Time frame: 12 weeks

Secondary outcomes

  1. Insulin and glucose response

    Time frame: 12 weeks

  2. Inflammatory Markers

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 28, 2007
Registry last updated
Jan 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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