Skip to main content
OpenTrials
Completed

NCT Number: NCT04417205

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Carbohydrate Rich Breakfast

Other

Participants will be asked to consume the provided carbohydrate rich breakfast before 1000h daily for 28 days.

Whey protein enriched breakfast

Dietary Supplement

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

Primary outcomes

  1. Change in physical activity thermogenesis

    Time frame: 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.

    Energy expenditure measured using physical activity monitor

  2. Change in expression of circadian clock genes measured in whole blood

    Time frame: Baseline and 4-weeks

    Pre and post intervention change clock gene expression

  3. Change in postprandial glycaemia following carbohydrate rich test breakfast and lunch over 4 weeks

    Time frame: Baseline and 4-weeks

    The postprandial time course response of plasma glucose to the test breakfast and lunch meals

  4. Change in postprandial insulinaemia following carbohydrate rich test breakfast and lunch over 4 weeks

    Time frame: Assessed at baseline and after 4 weeks of the intervention

    The postprandial time course response of plasma insulin to the test breakfast and lunch meals

  5. Change in body mass

    Time frame: 4 weeks

    Participants will be weighed prior to the intervention and again upon completion

Secondary outcomes

  1. Change in postprandial incretin hormone response following breakfast and lunch

    Time frame: Baseline and 4 weeks

    The postprandial time course response of plasma incretin hormones (e.g. GLP-1 & GIP) to the the test breakfast.

  2. Change in subjective appetite ratings following breakfast and lunch

    Time frame: Baseline and 4 weeks

    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

  3. Change in fuel oxidation during the test breakfast

    Time frame: Baseline and 4 weeks

    Fat and carbohydrate oxidation following breakfast

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.