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

Primary Purpose

Impaired Glucose Tolerance, Type 2 Diabetes, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

High dairy and calcium intake

Usual intake

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance focused on measuring Prediabetes, Type 2 diabetes, Metabolic syndrome, Insulin resistance syndrome, Weight loss, Milk products, Calcium

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 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.

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.

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Insulin and glucose response

Inflammatory Markers

Full Information

NCT ID

NCT00564551

First Posted

November 26, 2007

Last Updated

January 19, 2010

Sponsor

University of Calgary

1. Study Identification

Unique Protocol Identification Number

NCT00564551

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Calgary

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impaired Glucose Tolerance, Type 2 Diabetes, Metabolic Syndrome

Keywords

Prediabetes, Type 2 diabetes, Metabolic syndrome, Insulin resistance syndrome, Weight loss, Milk products, Calcium

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm 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.

Arm Title

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

High dairy and calcium intake

Other Intervention Name(s)

Jamieson Mega Cal™ Chewable Calcium (350 mg) tablet

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Usual intake

Intervention Description

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 Outcome Measure Information:

Title

Weight loss

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Insulin and glucose response

Time Frame

12 weeks

Title

Inflammatory Markers

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raylene A. Reimer, PhD, RD

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 1N4

Country

Canada

12. IPD Sharing Statement

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

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