Effect of Increased Intake of Low Fat Dairy Products on Weight Loss and Insulin Resistance
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Impaired Glucose Tolerance Type 2 Diabetes Metabolic Syndrome |
Behavioral: High dairy and calcium intake Behavioral: Usual intake |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Impact of High Milk Product and Calcium Intake During Weight Loss on Markers of Insulin Resistance |
- Weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Insulin and glucose response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Inflammatory Markers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 49 |
| Study Start Date: | October 2007 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Alberta | |
| Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research | |
| Calgary, Alberta, Canada, T2N 1N4 | |
| Principal Investigator: | Raylene A. Reimer, PhD, RD | University of Calgary |
More Information
No publications provided
| Responsible Party: | Raylene Reimer, Associate Professor, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00564551 History of Changes |
| Other Study ID Numbers: | UC 21076 |
| Study First Received: | November 26, 2007 |
| Last Updated: | January 19, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Calgary:
|
Prediabetes Type 2 diabetes Metabolic syndrome Insulin resistance syndrome |
Weight loss Milk products Calcium |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Weight Loss Glucose Intolerance Metabolic Syndrome X Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperinsulinism |
Body Weight Changes Body Weight Signs and Symptoms Hyperglycemia Calcium, Dietary Insulin Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Hypoglycemic Agents |
ClinicalTrials.gov processed this record on June 17, 2013