Isolating and Exploiting the Mechanisms That Link Breakfast and Human Health - Intervention

NCT ID: NCT04417205

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2022-08-01

Brief Summary

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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.

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.

Detailed Description

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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.

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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Physical Activity Postprandial Metabolism Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomised to one of 3 intervention arms.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Where applicable (i.e. the two breakfast feeding interventions) participants will be blinded to the breakfast that they receive for 28-days.

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.

Group Type ACTIVE_COMPARATOR

Carbohydrate Rich Breakfast

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Whey protein enriched breakfast

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Whey protein enriched breakfast

Participants will be asked to consume the provided whey protein enriched breakfast before 1000h daily for 28 days.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Body mass index 18.5-29.9 kg∙m-2
* 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 reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
* 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%)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bath

OTHER

Sponsor Role lead

Responsible Party

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James Betts

Professor James Betts

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type BACKGROUND
PMID: 23446906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25733634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25733459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26864365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24898233 (View on PubMed)

Other Identifiers

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DC-I

Identifier Type: -

Identifier Source: org_study_id

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