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OpenTrials
Completed

NCT Number: NCT03866720

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

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.

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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 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.

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

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

Whey protein enriched breakfast

Dietary Supplement

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

Primary outcomes

  1. Postprandial glycaemia following breakfast

    Time frame: Plasma glucose time course data over 3 hours following breakfast

    The postprandial time course response of plasma glucose to each breakfast meal

  2. Postprandial insulinaemia following breakfast

    Time frame: Plasma insulin time course data over 3 hours following breakfast

    The postprandial time course response of plasma insulin to each breakfast meal

  3. Postprandial glycaemia following ad libitum lunch

    Time frame: Plasma glucose time course data over 2 hours following lunch

    The postprandial time course response of Plasma glucose to the ad libitum lunch following each type of breakfast

  4. Postprandial insulinaemia following ad libitum lunch

    Time frame: Plasma insulin time course data over 2 hours following lunch

    The postprandial time course response of plasma insulin to the ad libitum lunch following each type of breakfast

Secondary outcomes

  1. Postprandial incretin hormone response following breakfast

    Time frame: Plasma insulin time course data over 3 hours following breakfast

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

  2. Postprandial incretin hormone response following ad libitum lunch

    Time frame: Plasma incretin time course data over 3 hours following breakfast

    The postprandial time course response of plasma incretin hormones (e.g. GLP-1 & GIP) to the ad libitum lunch following each type of breakfast

  3. Subjective appetite ratings following breakfast

    Time frame: For 3 hours following each breakfast

    Ratings 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.

  4. Subjective appetite ratings following ad libitum lunch

    Time frame: For 3 hours following the ad libitum lunch

    Ratings 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.

  5. Fuel oxidation following breakfast

    Time frame: For 3 hours following breakfast

    Fat and carbohydrate oxidation following each type of breakfast

  6. Fuel oxidation following ad libitum lunch

    Time frame: For 2 hours following the ad libitum lunch

    Fat and carbohydrate oxidation following ad libitum lunch

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 7, 2019
Registry last updated
Mar 4, 2021

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.

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