Clinical trial NCT03866720: Isolating & Exploiting the Mechanisms That Link Breakfast to Human Health - Acute
Official title: Isolating & Exploiting the Mechanisms That Link Breakfast to Human Health - Acute
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Metabolism
Appetite
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will complete 3 breakfast feeding trials in a randomised order:

Typical high carbohydrate breakfast followed by an ad libitum lunch. Whey protein enriched carbohydrate followed by an ad libitum lunch. Extended morning fast followed by an ad libitum lunch.
Primary purpose: BASIC_SCIENCE

Brief summary: 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 crossover design) of a wider project.

Detailed description: 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 involved to maximised 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 take part a randomised crossover trial that will contrast the acute metabolic responses to a protein-enriched breakfast, with a carbohydrate rich breakfast, and the total omission of breakfast.

Eligibility criteria: 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%)

Primary outcomes:
measure: Postprandial glycaemia following breakfast
timeFrame: Plasma glucose time course data over 3 hours following breakfast
measure: Postprandial insulinaemia following breakfast
timeFrame: Plasma insulin time course data over 3 hours following breakfast
measure: Postprandial glycaemia following ad libitum lunch
timeFrame: Plasma glucose time course data over 2 hours following lunch
measure: Postprandial insulinaemia following ad libitum lunch
timeFrame: Plasma insulin time course data over 2 hours following lunch
Secondary outcomes:
measure: Postprandial incretin hormone response following breakfast
timeFrame: Plasma insulin time course data over 3 hours following breakfast
measure: Postprandial incretin hormone response following ad libitum lunch
timeFrame: Plasma incretin time course data over 3 hours following breakfast
measure: Subjective appetite ratings following breakfast
timeFrame: For 3 hours following each breakfast
measure: Subjective appetite ratings following ad libitum lunch
timeFrame: For 3 hours following the ad libitum lunch
measure: Fuel oxidation following breakfast
timeFrame: For 3 hours following breakfast
measure: Fuel oxidation following ad libitum lunch
timeFrame: For 2 hours following the ad libitum lunch
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
state: Somerset
Study officials:
affiliation: University of Bath
name: Harry A Smith, MSci
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bath
name: James A Betts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chowdhury EA, Richardson JD, Tsintzas K, Thompson D, Betts JA. Carbohydrate-rich breakfast attenuates glycaemic, insulinaemic and ghrelin response to ad libitum lunch relative to morning fasting in lean adults. Br J Nutr. 2015 Jul 14;114(1):98-107. doi: 10.1017/S0007114515001506. Epub 2015 May 25.
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.
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.
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.