Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-01 @ 6:15 AM
Study NCT ID:
NCT02497859
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2015-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breakfast Intake and Satiety Hormones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004038', 'term': 'Diet, Reducing'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2015-07-08', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in subjective hunger questionnaire (Visual Analog Scale)', 'timeFrame': 'Change in scores (arbitrary units AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.'}, {'measure': 'Change in serum satiety and hunger hormones', 'timeFrame': 'Change (AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.', 'description': 'Concentrations of ghrelin, GLP1, PYY 3-36, insulin, and serum glucose will be determined. This is only for experiment 1.'}, {'measure': 'Energy intake (kcal) during ad libitum lunch', 'timeFrame': 'Test day 7 (30 minutes for buffet).', 'description': 'This is for experiment 1.'}, {'measure': 'Energy intake (kcal) during ad libitum lunch', 'timeFrame': 'Test day 14 (30 minutes for buffet).', 'description': 'This is for experiment 1.'}, {'measure': 'Energy intake (kcal) during ad libitum dinner', 'timeFrame': 'Test day 7 (30 minutes for buffet).', 'description': 'This is for experiment 1.'}, {'measure': 'Energy intake (kcal) during ad libitum dinner', 'timeFrame': 'Test day 14 (30 minutes for buffet).', 'description': 'This is for experiment 1.'}, {'measure': 'Energy intake (kcal) during ad libitum lunch', 'timeFrame': 'Test day 7 (30 minutes for buffet).', 'description': 'This is for experiment 2. Chocolate brownies will be added to the test lunch.'}, {'measure': 'Energy intake (kcal) during ad libitum lunch', 'timeFrame': 'Test day 14 (30 minutes for buffet).', 'description': 'This is for experiment 2. Chocolate brownies will be added to the test lunch.'}], 'secondaryOutcomes': [{'measure': 'Change in body weight in kilograms', 'timeFrame': 'Change in kilograms from baseline to test day 7.'}, {'measure': 'Change in body weight in kilograms', 'timeFrame': 'Change in kilograms from test day 7 to test day 14.'}, {'measure': 'Change in waist and hip circumference in centimeters', 'timeFrame': 'Change in centimeters from baseline to test day 7.'}, {'measure': 'Change in waist and hip circumference in centimeters', 'timeFrame': 'Change in centimeters from test day 7 to test day 14.'}, {'measure': 'Change in blood pressure (mm Hg)', 'timeFrame': 'Change in mm Hg from baseline to test day 7.'}, {'measure': 'Change in blood pressure (mm Hg)', 'timeFrame': 'Change in mm Hg from test day 7 to test day 14.'}, {'measure': 'Change in fat mass and lean body mass percentage', 'timeFrame': 'Change in percentage from test day 0 to test day 14.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Weight Reduction', 'Weight Loss Diet', 'Satiety Response', 'Insulin', 'Glucagon-Like Peptide 1', 'PYY (3-36) peptide', 'Ghrelin', 'Glucose', 'Eggs', 'Protein', 'Energy Intake', 'Breakfast'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '24703415', 'type': 'BACKGROUND', 'citation': 'Bayham BE, Greenway FL, Johnson WD, Dhurandhar NV. A randomized trial to manipulate the quality instead of quantity of dietary proteins to influence the markers of satiety. J Diabetes Complications. 2014 Jul-Aug;28(4):547-52. doi: 10.1016/j.jdiacomp.2014.02.002. Epub 2014 Feb 13.'}, {'pmid': '18679412', 'type': 'BACKGROUND', 'citation': 'Vander Wal JS, Gupta A, Khosla P, Dhurandhar NV. Egg breakfast enhances weight loss. Int J Obes (Lond). 2008 Oct;32(10):1545-51. doi: 10.1038/ijo.2008.130. Epub 2008 Aug 5.'}, {'pmid': '16373948', 'type': 'BACKGROUND', 'citation': 'Vander Wal JS, Marth JM, Khosla P, Jen KL, Dhurandhar NV. Short-term effect of eggs on satiety in overweight and obese subjects. J Am Coll Nutr. 2005 Dec;24(6):510-5. doi: 10.1080/07315724.2005.10719497.'}]}, 'descriptionModule': {'briefSummary': 'The experiments in this study will assess if while following a reduced energy diet, eating a breakfast with higher protein quality will enhance weight loss compared to another breakfast with lower protein quality, but matched for energy density and macronutrient composition.', 'detailedDescription': 'There will be 2 experiments in this pilot study. Both will be randomized crossover study designs with subjects beginning on either an egg breakfast of higher protein quality or cereal breakfast of lower protein quality, and reversing to receive the breakfast not previously ingested. The subjects will consume breakfasts under supervision at our clinic on all days of the study, except for weekends. Subjects will be advised to continue eating their breakfast at home on weekends. All subjects will receive weight loss counseling and follow a weight loss diet for 2 weeks. Experiment 1 will test the hypothesis that when on a reduced calorie diet, intake of an egg breakfast compared to cereal breakfast increases satiety, reduces lunch time energy consumption and reduces dinner time energy consumption in clinical and free living condition. Insulin, glucagon-like peptide-1, peptide YY 3-36, ghrelin, plasma glucose, baseline and post intervention anthropomorphic measurements, and hunger questionnaires completed during the consumption of both breakfasts and subsequent meals will be compared. Experiment 2 will compare the effects of the two breakfasts on intake of foods considered tempting or highly palatable, and assessment of energy intake pre/post test lunch followed by offering brownies. It is hypothesized that consumption of an egg breakfast compared to cereal breakfast, will help in reducing intake of foods considered tempting.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Calculated BMI of 25.0-39.9 kg/m2\n* Sedentary (\\< 3 hours/week of moderate intensity physical activity)\n* Otherwise healthy\n\nExclusion Criteria:\n\n* ≥5% body weight loss or gain in the three months preceding the study\n* Post-menopausal (has not had period for 12 months)\n* Plans to begin an exercise program or change current exercise routines between initiation of study and final study\n* Anyone following a medical diet prescription\n* Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type\n* Health conditions and chronic illness that contraindicate behavioral weight loss treatment using a low calorie diet\n* Anyone who is currently pregnant, or lactating\n* Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling\n* Plans to begin taking any supplements that may influence weight loss\n* Report of medical condition or surgical intervention that affects swallowing or chewing ability\n* Anyone with a pacemaker or other internal medical device\n* Any practicing vegans or vegetarians\n* Any practicing gluten-free diet\n* Allergy, aversion, or dislike to any of the foods offered for meals'}, 'identificationModule': {'nctId': 'NCT02497859', 'briefTitle': 'Breakfast Intake and Satiety Hormones', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University'}, 'officialTitle': 'Does Higher Protein Quality Breakfast Reduce Energy Intake When Following a Weight Loss Diet Plan?', 'orgStudyIdInfo': {'id': '505159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Egg Breakfast (EB)', 'description': 'The EB will receive the following breakfast:\n\n2 scrambled eggs, 120 mL skim milk, 2 slices of Mrs. Bairds® Extra Thin White Bread, 5 g of butter, and 18 g of Smuckers® Strawberry Jam.', 'interventionNames': ['Behavioral: Egg Breakfast (EB)', 'Behavioral: Weight Loss Counseling', 'Behavioral: Weight Loss Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cereal Breakfast (CB)', 'description': "The CB will receive the following breakfast:\n\n1.5 cups of Special K® Ready-to-Eat Original Cereal, 200 ml Silk® Original Soymilk, 1 slice of Nature's Own® Double Fiber Wheat Bread, 13 g of butter, and 10 g of Smuckers® Sugar-Free Strawberry Jam.", 'interventionNames': ['Behavioral: Cereal Breakfast (CB)', 'Behavioral: Weight Loss Counseling', 'Behavioral: Weight Loss Diet']}], 'interventions': [{'name': 'Egg Breakfast (EB)', 'type': 'BEHAVIORAL', 'description': 'The EB will receive a breakfast of higher quality protein, but similar in macronutrient and energy density than the active comparator. The EB will have the following energy density, macronutrient composition, and protein score: weight 291 g,energy 400 kcal, energy density 1.37 kcal/g, carbohydrate 42.9%, fat 35.5%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 100, leucine 1.77 g, glycemic load 24, fiber 1.0 g.', 'armGroupLabels': ['Egg Breakfast (EB)']}, {'name': 'Cereal Breakfast (CB)', 'type': 'BEHAVIORAL', 'description': 'The CB will receive a breakfast of lower quality protein, but similar in macronutrient and energy density than the experimental treatment. The CB will have the following energy density, macronutrient composition, and protein score: weight 293 g, energy 398 kcal, energy density 1.3 kcal/g, carbohydrate 44.8%, fat 35.4%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 42, leucine 0.48 g, glycemic load 30.8, fiber 4.4 g.', 'armGroupLabels': ['Cereal Breakfast (CB)']}, {'name': 'Weight Loss Counseling', 'type': 'BEHAVIORAL', 'description': 'Weight loss counseling will be administered by a Registered Dietitian and will utilize information and materials derived from the Evidence Analysis Library (EAL) of the Academy of Nutrition and Dietetics (AND). Topics including portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, will be discussed. Self-monitoring, motivational interviewing, goal setting, and problem solving will be the behavioral strategies used during counseling.', 'armGroupLabels': ['Cereal Breakfast (CB)', 'Egg Breakfast (EB)']}, {'name': 'Weight Loss Diet', 'type': 'BEHAVIORAL', 'description': "Energy intake for study duration will be prescribed at 1,200-1,500 kcals adjusted for each individual's body weight.", 'armGroupLabels': ['Cereal Breakfast (CB)', 'Egg Breakfast (EB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79409', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University - Department of Nutritional Sciences', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'overallOfficials': [{'name': 'Nikhil Dhurandhar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chair of the Nutritional Sciences Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Egg Board', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nikhil Dhurandhar', 'investigatorAffiliation': 'Texas Tech University'}}}}