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Isolating & Exploiting the Mechanisms That Link Breakfast to Human Health - Acute

Isolating & Exploiting the Mechanisms That Link Breakfast to Human Health - Acute

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03866720
Enrollment
12
Registered
2019-03-07
Start date
2019-02-26
Completion date
2021-02-17
Last updated
2021-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appetite, Postprandial Metabolism

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.

Interventions

A porridge breakfast meal fed at a carbohydrate delivery rate of 7.3 mg/kJ of each participants resting metabolic rate.

A porridge breakfast meal in which 15 grams of whey protein is substituted in place of carbohydrate and a small portion of fat.

Sponsors

University of Bath
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Where applicable (i.e. the two breakfast feeding trials) participants will be blinded to the breakfast that they receive.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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%)

Design outcomes

Primary

MeasureTime frameDescription
Postprandial glycaemia following breakfastPlasma glucose time course data over 3 hours following breakfastThe postprandial time course response of plasma glucose to each breakfast meal
Postprandial insulinaemia following breakfastPlasma insulin time course data over 3 hours following breakfastThe postprandial time course response of plasma insulin to each breakfast meal
Postprandial glycaemia following ad libitum lunchPlasma glucose time course data over 2 hours following lunchThe postprandial time course response of Plasma glucose to the ad libitum lunch following each type of breakfast
Postprandial insulinaemia following ad libitum lunchPlasma insulin time course data over 2 hours following lunchThe postprandial time course response of plasma insulin to the ad libitum lunch following each type of breakfast

Secondary

MeasureTime frameDescription
Fuel oxidation following breakfastFor 3 hours following breakfastFat and carbohydrate oxidation following each type of breakfast
Postprandial incretin hormone response following breakfastPlasma insulin time course data over 3 hours following breakfastThe postprandial time course response of plasma incretin hormones (e.g. GLP-1 & GIP) to the each breakfast.
Fuel oxidation following ad libitum lunchFor 2 hours following the ad libitum lunchFat and carbohydrate oxidation following ad libitum lunch
Postprandial incretin hormone response following ad libitum lunchPlasma incretin time course data over 3 hours following breakfastThe postprandial time course response of plasma incretin hormones (e.g. GLP-1 & GIP) to the ad libitum lunch following each type of breakfast
Subjective appetite ratings following breakfastFor 3 hours following each breakfastRatings of appetite provided on subjective appetite scales following each type of breakfast. On a scale of 0-100mm with 0 typically being associated with lower subjective ratings and 100 being associated with higher subjective ratings.
Subjective appetite ratings following ad libitum lunchFor 3 hours following the ad libitum lunchRatings of appetite provided on subjective appetite scales following ad libitum lunch. On a scale of 0-100mm with 0 typically being associated with lower subjective ratings and 100 being associated with higher subjective ratings.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026