Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-26 @ 5:49 AM
Study NCT ID:
NCT04623450
Status:
UNKNOWN
Last Update Posted:
2020-11-12
First Post:
2020-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Macronutrients and Satiety in Older and Younger Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001070', 'term': 'Appetitive Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-09-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ad-libitum meal consumption', 'timeFrame': '3 days in total', 'description': 'Consumption of the ad-libitum meal is measured (g). Participants are instructed to eat until they feel comfortable full and are given 20 min to consume the meal.'}], 'secondaryOutcomes': [{'measure': 'Ratings of appetite', 'timeFrame': '3 days in total', 'description': 'Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).'}, {'measure': 'Gastric Emptying', 'timeFrame': '3 days in total', 'description': 'Gastric emptying is measured using of 13C octanoic acid breath test'}, {'measure': 'Ratings of palatability', 'timeFrame': '3 days in total', 'description': 'Palatability ratings are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['younger adults', 'older adults', 'appetite', 'satiety', 'macronutrients'], 'conditions': ['Appetitive Behavior', 'Gastric Emptying']}, 'referencesModule': {'references': [{'pmid': '24814383', 'type': 'BACKGROUND', 'citation': 'Deutz NE, Bauer JM, Barazzoni R, Biolo G, Boirie Y, Bosy-Westphal A, Cederholm T, Cruz-Jentoft A, Krznaric Z, Nair KS, Singer P, Teta D, Tipton K, Calder PC. Protein intake and exercise for optimal muscle function with aging: recommendations from the ESPEN Expert Group. Clin Nutr. 2014 Dec;33(6):929-36. doi: 10.1016/j.clnu.2014.04.007. Epub 2014 Apr 24.'}, {'pmid': '9039015', 'type': 'BACKGROUND', 'citation': 'Clarkston WK, Pantano MM, Morley JE, Horowitz M, Littlefield JM, Burton FR. Evidence for the anorexia of aging: gastrointestinal transit and hunger in healthy elderly vs. young adults. Am J Physiol. 1997 Jan;272(1 Pt 2):R243-8. doi: 10.1152/ajpregu.1997.272.1.R243.'}, {'pmid': '8475895', 'type': 'BACKGROUND', 'citation': 'Blundell JE, Burley VJ, Cotton JR, Lawton CL. Dietary fat and the control of energy intake: evaluating the effects of fat on meal size and postmeal satiety. Am J Clin Nutr. 1993 May;57(5 Suppl):772S-777S; discussion 777S-778S. doi: 10.1093/ajcn/57.5.772S.'}, {'pmid': '7661908', 'type': 'BACKGROUND', 'citation': 'Rolls BJ, Kim-Harris S, Fischman MW, Foltin RW, Moran TH, Stoner SA. Satiety after preloads with different amounts of fat and carbohydrate: implications for obesity. Am J Clin Nutr. 1994 Oct;60(4):476-87. doi: 10.1093/ajcn/60.4.476.'}, {'pmid': '29704915', 'type': 'BACKGROUND', 'citation': 'Clegg ME, Williams EA. Optimizing nutrition in older people. Maturitas. 2018 Jun;112:34-38. doi: 10.1016/j.maturitas.2018.04.001. Epub 2018 Apr 4.'}, {'pmid': '28747330', 'type': 'BACKGROUND', 'citation': 'Giezenaar C, Trahair LG, Luscombe-Marsh ND, Hausken T, Standfield S, Jones KL, Lange K, Horowitz M, Chapman I, Soenen S. Effects of randomized whey-protein loads on energy intake, appetite, gastric emptying, and plasma gut-hormone concentrations in older men and women. Am J Clin Nutr. 2017 Sep;106(3):865-877. doi: 10.3945/ajcn.117.154377. Epub 2017 Jul 26.'}, {'pmid': '28431774', 'type': 'BACKGROUND', 'citation': 'Appleton KM. Limited compensation at the following meal for protein and energy intake at a lunch meal in healthy free-living older adults. Clin Nutr. 2018 Jun;37(3):970-977. doi: 10.1016/j.clnu.2017.03.032. Epub 2017 Apr 7.'}, {'pmid': '28112772', 'type': 'BACKGROUND', 'citation': 'Beelen J, de Roos NM, de Groot LC. Protein Enrichment of Familiar Foods as an Innovative Strategy to Increase Protein Intake in Institutionalized Elderly. J Nutr Health Aging. 2017;21(2):173-179. doi: 10.1007/s12603-016-0733-y.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake, perceived appetite and gastric emptying in younger (\\<40 years) and older (\\> 65 years) people living in the United Kingdom (UK).', 'detailedDescription': "To assess if increasing protein intake in older adults will have a compensatory decrease in energy intake due to protein's satiating effects.\n\nTo compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake and perceived appetite in younger (\\<40 years) and older adults (\\>65 years).\n\nTo compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on gastric emptying in younger (\\<40 years) and older adults (\\>65 years)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* either aged \\>65 years or \\<40 years\n* healthy\n\nExclusion Criteria:\n\n* having a disease and/or using a medication that can impact on appetite in the past three months;\n* having an allergy to any of the test foods;\n* disliking or cannot eat any of the test foods;\n* being pregnant or breastfeeding;\n* being obese (BMI \\> 30 kg/m2);\n* being on a weight loss diet;\n* smoking more than 10 cigarettes a day.'}, 'identificationModule': {'nctId': 'NCT04623450', 'acronym': 'MACROSAT', 'briefTitle': 'Macronutrients and Satiety in Older and Younger Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Reading'}, 'officialTitle': 'The Effect of Different Macronutrients on Appetite and Satiety in Older and Younger Adults', 'orgStudyIdInfo': {'id': 'UREC 19/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Carbohydrate Meal', 'description': 'A smoothie including maltodextrin and low-fat strawberry yoghurt - 289 kcal, 61g carbohydrate, 6.7g protein, 1.9g fat.', 'interventionNames': ['Other: Smoothie']}, {'type': 'EXPERIMENTAL', 'label': 'High Fat Meal', 'description': 'A smoothie including double cream and low-fat strawberry yoghurt - 312 kcal, 13.3g carbohydrate, 7g protein, 25.5g fat.', 'interventionNames': ['Other: Smoothie']}, {'type': 'EXPERIMENTAL', 'label': 'High Protein Meal', 'description': 'A smoothie including whey protein and low-fat strawberry yoghurt - 307 kcal, 13.6g carbohydrate, 57g protein, 2.7g fat.', 'interventionNames': ['Other: Smoothie']}], 'interventions': [{'name': 'Smoothie', 'type': 'OTHER', 'description': 'Preload smoothies that are matched for taste, smell, appearance, quantity and calorie but different caloric content.', 'armGroupLabels': ['High Carbohydrate Meal', 'High Fat Meal', 'High Protein Meal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reading', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Miriam Clegg, BSc, PhD', 'role': 'CONTACT', 'email': 'm.e.clegg@reading.ac.uk', 'phone': '+44 (0)118 378 8723'}, {'name': 'Lisa Methven, BSc, PhD', 'role': 'CONTACT', 'email': 'l.methven@reading.ac.uk', 'phone': '+44 (0)118 378 8714'}], 'facility': 'University of Reading', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'centralContacts': [{'name': 'Miriam Clegg, BSc, PhD', 'role': 'CONTACT', 'email': 'm.e.clegg@reading.ac.uk', 'phone': '+44 (0)118 378 8723'}, {'name': 'Lisa Methven, BSc, PhD', 'role': 'CONTACT', 'email': 'l.methven@reading.ac.uk', 'phone': '+44 (0)118 378 8714'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No personal identification data will be shared. The study is not under an obligation to share data, however, it is possible that some of the individual (unliked / non-identifiable) data will be useful in a meta-analysis and, hence sharing individual participant data (IPD) will be considered.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Reading', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of National Education, Turkey', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Miriam Clegg', 'investigatorAffiliation': 'University of Reading'}}}}