Effect of Increased Intake of Low Fat Dairy Products on Weight Loss and Insulin Resistance - Full Text View

Sponsor:	University of Calgary
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00564551

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Calcium Diabetes Diabetes Medicines Diabetes Type 2 Metabolic Syndrome Weight Control

Drug Information available for: Insulin Insulin beef Calcium gluconate

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:

Weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564551

Locations

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

Sponsors and Collaborators

University of Calgary

Investigators

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 February 09, 2012