Isolating and Exploiting the Mechanisms That Link Breakfast and Human Health - Intervention
NCT ID: NCT04417205
Last Updated: 2023-04-18
Study Results
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Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2019-02-26
2022-08-01
Brief Summary
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To begin investigating the outlined mechanisms healthy, non-obese participants will be recruited to take part in phase I (acute design) of a wider project.
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Detailed Description
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Specifically, 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.
To 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:
Carbohydrate rich breakfast
Whey protein enriched breakfast
Extended morning fast
Participants 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.
Upon completion of the intervention phase participants will revisit the laboratory to replicate the initial visit in which postprandial metabolism was assessed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Carbohydrate rich breakfast
Participants will be provided with 28-days worth of pre-weighed carbohydrate rich breakfast materials to consume before 1000h daily.
Carbohydrate Rich Breakfast
Participants will be asked to consume the provided carbohydrate rich breakfast before 1000h daily for 28 days.
Whey protein enriched breakfast
Participants will be provided with 28-days worth of pre-weighed whey protein enriched rich breakfast materials to consume before 1000h daily.
Whey protein enriched breakfast
Participants will be asked to consume the provided whey protein enriched breakfast before 1000h daily for 28 days.
Extended morning fast
Participants will be asked to remain fasted (i.e. to not consume breakfast) until 1200h daily for 28-days.
No interventions assigned to this group
Interventions
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Carbohydrate Rich Breakfast
Participants will be asked to consume the provided carbohydrate rich breakfast before 1000h daily for 28 days.
Whey protein enriched breakfast
Participants will be asked to consume the provided whey protein enriched breakfast before 1000h daily for 28 days.
Eligibility Criteria
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Inclusion Criteria
* Age 18-65 years
* Able and willing to provide informed consent and safely comply with study procedures
* Females to maintain record of regular menstrual cycle phase or contraceptive use
* No anticipated changes in diet/physical activity during the study (e.g. holidays or diet plans)
* Inclusive to all breakfast habits (e.g. regular skipper / consumer)
Exclusion Criteria
* Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
* 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)
* Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
* Any reported recent (\<6 months) change in body mass (± 3%)
18 Years
65 Years
ALL
Yes
Sponsors
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University of Bath
OTHER
Responsible Party
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James Betts
Professor James Betts
Principal Investigators
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Harry A Smith, MSci
Role: PRINCIPAL_INVESTIGATOR
University of Bath
James A Betts, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bath
Locations
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University of Bath
Bath, Somerset, United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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DC-I
Identifier Type: -
Identifier Source: org_study_id
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