Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 6:49 AM
Study NCT ID:
NCT04399460
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-28
First Post:
2020-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 93}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fecal Collection', 'timeFrame': 'Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.', 'description': 'Gut microbiome profiling'}, {'measure': 'Change in blood glucose levels', 'timeFrame': 'Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.', 'description': 'Each participant will attend 3 sessions in total'}, {'measure': 'Change in fasting insulin (µIU/mL) levels in the blood', 'timeFrame': 'Change from baseline at 12 weeks', 'description': 'Each participant will attend 3 sessions in total'}, {'measure': 'Change in gut hormone levels measured in the blood', 'timeFrame': 'Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.', 'description': 'Each participant will attend 3 sessions in total'}, {'measure': 'Change in triacylglycerol level (mg/dL)', 'timeFrame': 'Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.', 'description': 'Each participant will attend 3 sessions in total'}, {'measure': 'Change in HbA1c (mmol/mol)', 'timeFrame': 'Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.', 'description': 'Each participant will attend 3 sessions in total'}, {'measure': 'Change in red blood cells fatty acids', 'timeFrame': 'Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.', 'description': 'Each participant will attend 3 sessions in total'}, {'measure': 'Change in resting metabolic rate', 'timeFrame': 'Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.', 'description': 'Each participant will attend 3 sessions in total measured by Indirect calorimetry'}, {'measure': 'Change in short-chain fatty acids in the blood', 'timeFrame': 'Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.', 'description': 'Each participant will attend 3 sessions in total'}, {'measure': 'Change in waist and hip circumference in cm', 'timeFrame': 'Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.', 'description': 'Each participant will attend 3 sessions in total'}, {'measure': 'Change in lean body mass percentage measured by BodPod', 'timeFrame': 'Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.', 'description': 'Each participant will attend 3 sessions in total'}], 'primaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'Starting at the beginning of the study 0 week then biweekly for 7 sessions up to 12 weeks with a followed up at 16 weeks.', 'description': 'Each participant will attend 8 sessions biweekly in total'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight or Obesity', 'Body Weight']}, 'descriptionModule': {'briefSummary': 'The proposed study looks at the effect of long-term diet modification with or without full-fat dairy products or restrictive eating on body weight, body composition and cardiometabolic markers in healthy overweight/obese men and women.', 'detailedDescription': 'A total of 93 males and females will participate in the study at the University of Toronto.\n\nAt the beginning and after 12 weeks, body weight, composition will be measured through Bodpod scans. Resting metabolic rate and thermogenesis will be measured by indirect calorimetry. Also, fecal samples will be collected for gut microbiome profiling along with blood for glucose, insulin, hormones, triacylglycerol, HbA1c, short-chain fatty acid, red blood cells and FGF21. Urine samples will be collected throughout the study.\n\nA followup session at 16 weeks will reassess previous measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI: ≥ 27 and ≤ 34.9 kg/m2\n* Fasting serum glucose: ≤ 7 mmol/L\n* Low ≤1 serving of dairy consumption\n* Waist circumference \\>88cm (women) and \\>102cm (men)\n* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.\n* Willing to maintain current dietary supplement use throughout the trial. On test days, participant agrees not to take any dietary supplements until dismissal from the study. Failure to comply will result in a rescheduled test visit.\n* Willing to abstain from alcohol consumption for 24 h prior to all test visits.\n* Willing to avoid vigorous physical activity for 24 h prior to all test visits.\n* Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator\n\nExclusion Criteria:\n\n* Fasting blood glucose \\> 7 mmol/L\n* Triglycerides ≥ 2.3 mmol/L\n* Smoking tobacco products and marijuana\n* Thyroid problems\n* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.\n* Presence of gastrointestinal disorder or surgeries within the past year.\n* Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement.\n* Known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months.\n* Irregular menstrual cycles (i.e. frequent missed cycles), menopausal or post- menopausal\n* Unwillingness or inability to comply with the experimental procedures\n* Known intolerance, sensitivity or allergy to dairy products\n* Consumption of protein powders/protein supplements\n* Extreme dietary habits\n* Uncontrolled hypertension as defined by the average blood pressure measured at screening.\n* Weight gain or loss of at least 10 lbs in previous three months, and history of childhood overweight or obesity\n* Excessive alcohol intake\n* Restrained Eaters"}, 'identificationModule': {'nctId': 'NCT04399460', 'briefTitle': 'The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control', 'orgStudyIdInfo': {'id': 'DFC_LTDairy_2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dairy Energy Restrictive Diet', 'description': 'Low-dairy (\\<1 serving/day) and 500kcal/deficit per day energy restrictive diet', 'interventionNames': ['Other: Restrictive Eating']}, {'type': 'EXPERIMENTAL', 'label': '3 Servings of Full-Fat Dairy with Energy Restrictive diet', 'description': 'Energy-restrictive diet (500 kcal/deficit per day) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses', 'interventionNames': ['Other: Dairy-based commercially available food products', 'Other: Restrictive Eating']}, {'type': 'EXPERIMENTAL', 'label': '3 Servings of Full-Fat Dairy but no energy restriction', 'description': 'Normal diet (no energy restriction) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses', 'interventionNames': ['Other: Dairy-based commercially available food products']}], 'interventions': [{'name': 'Dairy-based commercially available food products', 'type': 'OTHER', 'description': 'Full-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses', 'armGroupLabels': ['3 Servings of Full-Fat Dairy but no energy restriction', '3 Servings of Full-Fat Dairy with Energy Restrictive diet']}, {'name': 'Restrictive Eating', 'type': 'OTHER', 'description': 'Dietitian will assist with 500 kcal/day reduction through limiting of macronutrients 45-65% energy from carbohydrates 20-35% energy from fat 10-35% energy from protein', 'armGroupLabels': ['3 Servings of Full-Fat Dairy with Energy Restrictive diet', 'Low Dairy Energy Restrictive Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3M 2J6', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Mount Saint Vincent University', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M5S 3E2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Department of Nutritional Sciences', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'G. Harvey Anderson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mount Saint Vincent University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'G. Harvey Anderson', 'investigatorAffiliation': 'University of Toronto'}}}}