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

Information source: University of Calgary
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Impaired Glucose Tolerance; Type 2 Diabetes; Metabolic Syndrome

Intervention: High dairy and calcium intake (Behavioral); Usual intake (Behavioral)

Phase: N/A

Status: Completed

Sponsored by: University of Calgary

Official(s) and/or principal investigator(s):
Raylene A. Reimer, PhD, RD, Principal Investigator, Affiliation: University of Calgary

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.

Clinical Details

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

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

Primary outcome: Weight loss

Secondary outcome:

Insulin and glucose response

Inflammatory Markers

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

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research, Calgary, Alberta T2N 1N4, Canada
Additional Information

Starting date: October 2007
Last updated: January 19, 2010

Page last updated: August 20, 2015

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