Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-02 @ 10:46 PM
Study NCT ID:
NCT00564551
Status:
COMPLETED
Last Update Posted:
2010-01-21
First Post:
2007-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Increased Intake of Low Fat Dairy Products on Weight Loss and Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-19', 'studyFirstSubmitDate': '2007-11-26', 'studyFirstSubmitQcDate': '2007-11-26', 'lastUpdatePostDateStruct': {'date': '2010-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Insulin and glucose response', 'timeFrame': '12 weeks'}, {'measure': 'Inflammatory Markers', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prediabetes', 'Type 2 diabetes', 'Metabolic syndrome', 'Insulin resistance syndrome', 'Weight loss', 'Milk products', 'Calcium'], 'conditions': ['Impaired Glucose Tolerance', 'Type 2 Diabetes', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight and obese (BMI of 27 to 37 kg/m2)\n* Impaired glucose tolerance (fasting blood glucose \\>5.6 mmol/L) or\n* Type 2 diabetes treated with diet and exercise alone (no medications)\n* One or more of the following criteria for metabolic syndrome:\n\n 1. Hypertriglyceridemia (\\> 1.70 mmol/L)\n 2. Low high-density lipoprotein (HDL) cholesterol (\\< 1.04 mmol/L in men and \\< 1.30 mmol/L in women)\n 3. High blood pressure (\\> 130/85 mm Hg)\n 4. High waist circumference ( \\> 94 cm in men, \\> 80 cm in women)\n* Weight stable and no changes in exercise in past 3 months\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Type 2 diabetes treated with oral hypoglycemic agents or insulin\n* HbA1c \\> 8%\n* myocardial infarction or have undergone a cardiovascular intervention within the past three months\n* Subjects taking fibrate or statins who have had a dose change within the 8 weeks prior to randomization\n* Liver or pancreas disease\n* Major gastrointestinal surgeries\n* Pregnant or lactating\n* Exhibit alcohol or drug dependence\n* Taking drugs influencing appetite\n* Have a milk allergy or lactose intolerance\n* Following a diet or exercise regime designed for weight loss\n* Have a body weight greater than 350 lb (weight limit for DEXA instrument)\n* Chronic use of bulk laxatives, antacids or calcium supplements'}, 'identificationModule': {'nctId': 'NCT00564551', 'briefTitle': 'Effect of Increased Intake of Low Fat Dairy Products on Weight Loss and Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Impact of High Milk Product and Calcium Intake During Weight Loss on Markers of Insulin Resistance', 'orgStudyIdInfo': {'id': 'UC 21076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', '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.', 'interventionNames': ['Behavioral: High dairy and calcium intake']}, {'type': 'PLACEBO_COMPARATOR', 'label': '1', '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.', 'interventionNames': ['Behavioral: Usual intake']}], 'interventions': [{'name': 'High dairy and calcium intake', 'type': 'BEHAVIORAL', 'otherNames': ['Jamieson Mega Cal™ Chewable Calcium (350 mg) tablet'], '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.', 'armGroupLabels': ['2']}, {'name': 'Usual intake', 'type': 'BEHAVIORAL', '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', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Raylene A. Reimer, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Raylene Reimer, Associate Professor', 'oldOrganization': 'University of Calgary'}}}}