Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-28 @ 5:12 PM
Study NCT ID:
NCT04417205
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2019-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolating and Exploiting the Mechanisms That Link Breakfast and Human Health - Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Where applicable (i.e. the two breakfast feeding interventions) participants will be blinded to the breakfast that they receive for 28-days.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomised to one of 3 intervention arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-15', 'studyFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in physical activity thermogenesis', 'timeFrame': 'Assessed for 1 week at baseline, 3 days a week during weeks 1-3 of the intervention and again for 1 week in the 4th week of the intervention.', 'description': 'Energy expenditure measured using physical activity monitor'}, {'measure': 'Change in expression of circadian clock genes measured in whole blood', 'timeFrame': 'Baseline and 4-weeks', 'description': 'Pre and post intervention change clock gene expression'}, {'measure': 'Change in postprandial glycaemia following carbohydrate rich test breakfast and lunch over 4 weeks', 'timeFrame': 'Baseline and 4-weeks', 'description': 'The postprandial time course response of plasma glucose to the test breakfast and lunch meals'}, {'measure': 'Change in postprandial insulinaemia following carbohydrate rich test breakfast and lunch over 4 weeks', 'timeFrame': 'Assessed at baseline and after 4 weeks of the intervention', 'description': 'The postprandial time course response of plasma insulin to the test breakfast and lunch meals'}, {'measure': 'Change in body mass', 'timeFrame': '4 weeks', 'description': 'Participants will be weighed prior to the intervention and again upon completion'}], 'secondaryOutcomes': [{'measure': 'Change in postprandial incretin hormone response following breakfast and lunch', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The postprandial time course response of plasma incretin hormones (e.g. GLP-1 \\& GIP) to the the test breakfast.'}, {'measure': 'Change in subjective appetite ratings following breakfast and lunch', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Ratings of appetite provided on subjective appetite scales (on a scale of 0-100 mm where 0 is associated with lower ratings and 100 with higher ratings) following the test breakfast and lunch'}, {'measure': 'Change in fuel oxidation during the test breakfast', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Fat and carbohydrate oxidation following breakfast'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Activity', 'Postprandial Metabolism', 'Weight Loss']}, 'referencesModule': {'references': [{'pmid': '23446906', 'type': 'BACKGROUND', 'citation': 'Leidy HJ, Ortinau LC, Douglas SM, Hoertel HA. Beneficial effects of a higher-protein breakfast on the appetitive, hormonal, and neural signals controlling energy intake regulation in overweight/obese, "breakfast-skipping," late-adolescent girls. Am J Clin Nutr. 2013 Apr;97(4):677-88. doi: 10.3945/ajcn.112.053116. Epub 2013 Feb 27.'}, {'pmid': '25733634', 'type': 'BACKGROUND', 'citation': 'Bray GA, Redman LM, de Jonge L, Covington J, Rood J, Brock C, Mancuso S, Martin CK, Smith SR. Effect of protein overfeeding on energy expenditure measured in a metabolic chamber. Am J Clin Nutr. 2015 Mar;101(3):496-505. doi: 10.3945/ajcn.114.091769. Epub 2015 Jan 14.'}, {'pmid': '25733459', 'type': 'BACKGROUND', 'citation': 'Park YM, Heden TD, Liu Y, Nyhoff LM, Thyfault JP, Leidy HJ, Kanaley JA. A high-protein breakfast induces greater insulin and glucose-dependent insulinotropic peptide responses to a subsequent lunch meal in individuals with type 2 diabetes. J Nutr. 2015 Mar;145(3):452-8. doi: 10.3945/jn.114.202549. Epub 2014 Dec 24.'}, {'pmid': '26864365', 'type': 'BACKGROUND', 'citation': 'Chowdhury EA, Richardson JD, Holman GD, Tsintzas K, Thompson D, Betts JA. The causal role of breakfast in energy balance and health: a randomized controlled trial in obese adults. Am J Clin Nutr. 2016 Mar;103(3):747-56. doi: 10.3945/ajcn.115.122044. Epub 2016 Feb 10.'}, {'pmid': '24898233', 'type': 'BACKGROUND', 'citation': 'Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults. Am J Clin Nutr. 2014 Aug;100(2):539-47. doi: 10.3945/ajcn.114.083402. Epub 2014 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'Following the establishment of causal links between breakfast consumption, the individual components of energy balance, and health it is now important to examine and target the underlying biological mechanisms involved to maximise potential health benefits.\n\nTo begin investigating the outlined mechanisms healthy, non-obese participants will be recruited to take part in phase I (acute design) of a wider project.', 'detailedDescription': 'Causal links between breakfast consumption, the individual components of energy balance, and health have recently been established and it is now important to examine and target the underlying biological mechanisms over a longer period of time to maximise potential health benefits.\n\nSpecifically, the substitution of a portion of carbohydrate for protein at breakfast may enhance the potential health benefits of breakfast through targeting distinct mechanistic pathways. Broadly, introducing a greater protein load at breakfast increases insulin secretion and delays gastric emptying, thereby eliciting a potentiated insulin response. In turn this may therefore improve glucose tolerance during a subsequent meal. Additionally, maintenance of euglycaemia following breakfast consumption, coupled with the thermic effect of feeding protein may accentuate the elevated energy expenditure following breakfast observed in previous studies. Finally, both the physical and chemical properties of protein exert a marked satiating effect. Collectively, these mechanisms could interact to maximise the net impact of breakfast on energy balance and associated health outcomes. However, whilst the evidence indicates obvious benefits of feeding a higher protein dose at breakfast, relatively little research has focused on the response to protein over multiple meals/days. Furthermore, and importantly, the mechanisms involved in the second-meal phenomenon and the potential for initial meals of varied composition to target these mechanisms have never been systematically investigated.\n\nTo begin investigating the outlined mechanisms healthy, non-obese participants will be recruited to undergo a 4 week intervention study in which they will consume one of three breakfasts for 28-days. The breakfast interventions provide will be:\n\nCarbohydrate rich breakfast\n\nWhey protein enriched breakfast\n\nExtended morning fast\n\nParticipants will undergo 7 days of habitual physical activity and diet monitoring prior to visiting the laboratory for their preliminary metabolic assessment in which they will consume the carbohydrate rich breakfast followed by an ad libitum meal for lunch. They will then be randomised to one of the 3 breakfast interventions for 28-days. During the 28-days weekly monitoring of physical activity and energy intake will take place in order to assess energy balance.\n\nUpon completion of the intervention phase participants will revisit the laboratory to replicate the initial visit in which postprandial metabolism was assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index 18.5-29.9 kg∙m-2\n* Age 18-65 years\n* Able and willing to provide informed consent and safely comply with study procedures\n* Females to maintain record of regular menstrual cycle phase or contraceptive use\n* No anticipated changes in diet/physical activity during the study (e.g. holidays or diet plans)\n* Inclusive to all breakfast habits (e.g. regular skipper / consumer)\n\nExclusion Criteria:\n\n* Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias\n* Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)\n* Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment (e.g. smoking/substance abuse)\n* Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)\n* Any reported recent (\\<6 months) change in body mass (± 3%)'}, 'identificationModule': {'nctId': 'NCT04417205', 'briefTitle': 'Isolating and Exploiting the Mechanisms That Link Breakfast and Human Health - Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Bath'}, 'officialTitle': 'Isolating and Exploiting the Mechanisms That Link Breakfast and Human Health - Intervention', 'orgStudyIdInfo': {'id': 'DC-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carbohydrate rich breakfast', 'description': 'Participants will be provided with 28-days worth of pre-weighed carbohydrate rich breakfast materials to consume before 1000h daily.', 'interventionNames': ['Other: Carbohydrate Rich Breakfast']}, {'type': 'EXPERIMENTAL', 'label': 'Whey protein enriched breakfast', 'description': 'Participants will be provided with 28-days worth of pre-weighed whey protein enriched rich breakfast materials to consume before 1000h daily.', 'interventionNames': ['Dietary Supplement: Whey protein enriched breakfast']}, {'type': 'NO_INTERVENTION', 'label': 'Extended morning fast', 'description': 'Participants will be asked to remain fasted (i.e. to not consume breakfast) until 1200h daily for 28-days.'}], 'interventions': [{'name': 'Carbohydrate Rich Breakfast', 'type': 'OTHER', 'description': 'Participants will be asked to consume the provided carbohydrate rich breakfast before 1000h daily for 28 days.', 'armGroupLabels': ['Carbohydrate rich breakfast']}, {'name': 'Whey protein enriched breakfast', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will be asked to consume the provided whey protein enriched breakfast before 1000h daily for 28 days.', 'armGroupLabels': ['Whey protein enriched breakfast']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BA2 7AY', 'city': 'Bath', 'state': 'Somerset', 'country': 'United Kingdom', 'facility': 'University of Bath', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}], 'overallOfficials': [{'name': 'Harry A Smith, MSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bath'}, {'name': 'James A Betts, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bath'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bath', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor James Betts', 'investigatorFullName': 'James Betts', 'investigatorAffiliation': 'University of Bath'}}}}