Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-28 @ 2:25 PM
Study NCT ID:
NCT01936935
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2013-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Assess the Effects of Dairy on Insulin Sensitivity and β-Cell Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080845', 'term': 'Sugar-Sweetened Beverages'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2013-09-03', 'studyFirstSubmitQcDate': '2013-09-03', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean circulating glucose level', 'timeFrame': '6 weeks', 'description': 'Mean circulating glucose level will be measured over 24 h in the continuous glucose monitoring (CGM) subset of subjects'}, {'measure': 'Mean daytime glucose values', 'timeFrame': '6 weeks', 'description': 'Mean daytime glucose values (6 am to 8 pm) measured in the CGM subset of subjects'}, {'measure': 'Mean evening/nighttime glucose values', 'timeFrame': '6 weeks', 'description': 'Mean evening/nighttime glucose values (8 pm to 6 am) measured in the CGM subset of subjects'}, {'measure': 'Mean peak postprandial glucose', 'timeFrame': '6 weeks', 'description': 'Mean peak postprandial glucose values during CGM after the lunch and dinner meals'}], 'primaryOutcomes': [{'measure': 'Matsuda Insulin Sensitivity Index (MISI)', 'timeFrame': '6 weeks', 'description': 'MISI calculated from glucose and insulin data obtained during a liquid meal tolerance test (LMTT). MISI = 10,000 divided by the square root of the quantity of fasting glucose x fasting insulin x mean post-load glucose from samples collected at 30, 60, 90 and 120 min after the start of the liquid meal x mean post-load insulin from samples collected at 30, 60, 90 and 120 min after the start of the liquid meal'}], 'secondaryOutcomes': [{'measure': 'Waist circumference', 'timeFrame': '6 weeks', 'description': 'Measured using a non-stretch anthropometric tape'}, {'measure': 'Blood pressure', 'timeFrame': '6 weeks', 'description': 'Standardized vital signs measurements will include resting blood pressure and pulse measured using an automated blood pressure measurement device.'}, {'measure': 'Fasting and 2-hr LMTT insulin and glucose concentrations', 'timeFrame': '6 weeks', 'description': 'During the LMTT subjects consume a liquid meal load (two-8 oz servings of Ensure®, Ross Products Division, Abbott Laboratories, Columbus, Ohio), and blood samples will be obtained at t = -10, 30, 60, 90, and 120 min ± 5 min where t = 0 min is the start of meal consumption. Serum insulin and plasma glucose concentrations will be measured in fasting (-10 min) and 2 hr (120 min) samples.'}, {'measure': 'Homeostasis model assessment of insulin resistance (HOMA-IR)', 'timeFrame': '6 weeks', 'description': 'HOMA-IR = the quantity of fasting glucose in mg/dL x fasting insulin in microunits/mL divided by 405'}, {'measure': 'Homeostasis model assessment of beta-cell function (HOMA%B)', 'timeFrame': '6 weeks', 'description': 'HOMA%B = 360 x fasting insulin in microunits/mL divided by fasting glucose in mg/dL minus 63'}, {'measure': 'Glucose total area under the curve (AUC) from 0-120 min', 'timeFrame': '6 weeks', 'description': 'Glucose total AUC 0-120 min will be calculated using the trapezoidal rule on glucose concentrations in blood samples collected at -10, 30, 60, 90, and 120 min where 0 min is the start of the liquid meal consumption in the LMTT.'}, {'measure': 'Insulin total AUC 0-120 min', 'timeFrame': '6 weeks', 'description': 'Insulin total AUC 0-120 min will be calculated using the trapezoidal rule on insulin concentrations in blood samples collected at -10, 30, 60, 90, and 120 min where 0 min is the start of the liquid meal consumption in the LMTT.'}, {'measure': '30 min Δ insulin/Δ glucose', 'timeFrame': '6 weeks', 'description': 'Change in insulin from baseline to 30 min of the LMTT will be divided by the change in glucose from baseline to 30 min of the LMTT'}, {'measure': 'AUC insulin/AUC glucose', 'timeFrame': '6 weeks', 'description': 'AUC for insulin divided by the AUC for glucose'}, {'measure': 'Disposition Index', 'timeFrame': '6 weeks', 'description': 'Disposition index = MISI x the quantity of AUC for insulin divided by the AUC for glucose'}, {'measure': 'Fasting plasma total cholesterol (total-C)', 'timeFrame': '6 weeks'}, {'measure': 'Fasting plasma low-density lipoprotein cholesterol (LDL-C)', 'timeFrame': '6 weeks', 'description': 'Calculated as LDL-C = total-C minus HDL-C minus the quantity of triglycerides (TG) divided by 5'}, {'measure': 'Fasting plasma high-density lipoprotein cholesterol (HDL-C)', 'timeFrame': '6 weeks'}, {'measure': 'Fasting plasma total-C/HDL-C', 'timeFrame': '6 weeks', 'description': 'Calculated as total-C concentration divided by HDL-C concentration'}, {'measure': 'Fasting plasma non-HDL-C', 'timeFrame': '6 weeks', 'description': 'Calculated as non-HDL-C = total-C minus HDL-C'}, {'measure': 'Fasting plasma TG', 'timeFrame': '6 weeks'}, {'measure': 'Serum 25-hydroxy vitamin D [25(OH)D]', 'timeFrame': '6 weeks'}, {'measure': 'Plasma high-sensitivity C-reactive protein (hs-CRP)', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insulin sensitivity'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '25733460', 'type': 'DERIVED', 'citation': 'Maki KC, Nieman KM, Schild AL, Kaden VN, Lawless AL, Kelley KM, Rains TM. Sugar-sweetened product consumption alters glucose homeostasis compared with dairy product consumption in men and women at risk of type 2 diabetes mellitus. J Nutr. 2015 Mar;145(3):459-66. doi: 10.3945/jn.114.204503. Epub 2015 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to evaluate the effects of dairy product consumption on insulin sensitivity and pancreatic β-cell function in men and women at risk for the development of type 2 diabetes mellitus (T2DM) who habitually consume beverages high in sugar (non-diet sodas and fruit juice cocktails).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject is male or female, 18-74 yrs of age, inclusive\n* subject reports habitual consumption of ≥2 servings/d of high-sugar beverages (e.g., non-diet soda, fruit juice cocktails)\n* subject has waist circumference ≥33.0 inches for women and ≥36.0 inches for men\n* subject is at risk for development of type 2 diabetes mellitus (T2DM), based on 1 or more of the following: fasting glucose 100-125 mg/dL; glycosylated hemoglobin 5.7-6.4%, or ≥20% risk of developing diabetes in the next 7.5 yrs based on the San Antonio Heart Study prediction equation\n* subject has a score of 7-10 on the Vein Access Scale at screening\n* subject is normally active and judged to be in good health on the basis of medical history, physical examination and routine lab tests\n* if female, subject is willing to schedule treatment visits during the follicular phase of the menstrual cycle, defined as days 1-14, where day 1 is 1st day of menses\n* subject has a menstrual cycle duration ranging in length form 24-36 d (if premenopausal)\n* subject is willing to maintain a stable body weight and follow his/her habitual diet and exercise pattern, except for inclusion of study product, throughout the trial\n* subject is willing to maintain his or her habitual intake of coffee, tea, and alcoholic beverages throughout the trial\n* subject agrees to limit intake of non-study related dairy products to ≤1 serving per day during each treatment period\n* subject is ambulatory and willing to refrain from vigorous physical activity and consumption of alcoholic beverages 24 h prior to each test day\n* subject has no plans to change smoking habits during the study period\n* subject is willing to abstain from tobacco use 1 h prior to and during visits on LMTT test days\n* subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine lab test results\n\nExclusion Criteria:\n\n* subject has abnormal lab test results of clinical importance, including, but not limited to, TG ≥400 mg/dL, fasting creatinine ≥1.5 mg/dL, alanine aminotransferase or aspartate aminotransferase ≥1.5 times the upper limit of normal at screening\n* subject has a body mass index ≥45.0 kg/m2\n* subject has fasting blood glucose ≥126 mg/dL at screening or known diabetes mellitus (type 1 or T2DM)\n* subject has a habitual intake of ≥4 servings/d of dairy food and beverages\n* subject has known allergy or sensitivity to study product or any ingredients of study product. Subjects with lactose intolerance will be allowed to use products such as Lactaid dietary supplements\n* subject has a history of coronary heart disease, congestive heart failure, or serious ventricular dysrhythmias (ventricular tachycardia or fibrillation)\n* subject has a change in body weight of \\>4.5 kg within 4 weeks of screening\n* subject uses medications known to influence carbohydrate metabolism\n* subject has recent use of antibiotics\n* subject has an active infection\n* subject has unstable use of anti-hypertensive medications, thyroid hormone replacement, or lipid-altering drugs within 4 weeks of screening\n* subject has unstable use of lipid-altering foods or dietary supplements within 4 weeks of screening\n* subject uses niacin at doses \\>200 mg/d within 4 weeks of screening\n* subject has history of extreme dietary habits, e.g., Atkins, high protein\n* subject has a history or presence of clinically important endocrine, cardiac, renal, hepatic, pulmonary, biliary, pancreatic, gastrointestinal, or neurologic disorders that could interfere with interpretation of study results\n* subject has history of dysphagia, swallowing disorders, or intestinal motility disorders\n* subject has history of cancer\n* subject has uncontrolled hypertension at screening (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg)'}, 'identificationModule': {'nctId': 'NCT01936935', 'briefTitle': 'Clinical Trial to Assess the Effects of Dairy on Insulin Sensitivity and β-Cell Function', 'organization': {'class': 'OTHER', 'fullName': 'Provident Clinical Research'}, 'officialTitle': 'A Randomized, Controlled, Crossover Trial to Assess the Effects of Dairy Intake on Insulin Sensitivity and β-Cell Function in Men and Women at Risk for Diabetes Who Are Habitual Consumers of High Sugar Beverages', 'orgStudyIdInfo': {'id': 'PRV-1222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-fat dairy', 'description': '3 servings/d of low-fat dairy', 'interventionNames': ['Other: Low-fat dairy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar-sweetened beverages', 'description': '3 servings/d of sugar-sweetened foods', 'interventionNames': ['Other: Sugar-sweetened beverages']}], 'interventions': [{'name': 'Low-fat dairy', 'type': 'OTHER', 'description': '2 servings/d of 2% non-flavored, unsweetened milk + 1 serving/d sweetened low-fat yogurt', 'armGroupLabels': ['Low-fat dairy']}, {'name': 'Sugar-sweetened beverages', 'type': 'OTHER', 'description': '2 servings/d of non-diet soda + 1 serving/d of non-dairy pudding', 'armGroupLabels': ['Sugar-sweetened beverages']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60101', 'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'facility': 'Provident Clinical Research (now Biofortis)', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}], 'overallOfficials': [{'name': 'Kevin C Maki, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biofortis Clinical Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Provident Clinical Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioFortis', 'class': 'OTHER'}, {'name': 'Dairy Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}