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

Sponsor
University of Bath (Other)
Overall Status
Completed
CT.gov ID
NCT03866720
Collaborator
(none)
12
1
3
23.7
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Carbohydrate rich breakfast
  • Dietary Supplement: Whey protein enriched breakfast
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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.
Masking:
Single (Participant)
Masking Description:
Where applicable (i.e. the two breakfast feeding trials) participants will be blinded to the breakfast that they receive.
Primary Purpose:
Basic Science
Official Title:
Isolating & Exploiting the Mechanisms That Link Breakfast to Human Health - Acute
Actual Study Start Date :
Feb 26, 2019
Actual Primary Completion Date :
Feb 17, 2021
Actual Study Completion Date :
Feb 17, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Carbohydrate rich breakfast

Participants will consume a porridge breakfast that is considered in line with typical carbohydrate consumption for this meal.

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

Experimental: Whey protein enriched breakfast

Participants will consume a porridge breakfast that is considered in line with typical carbohydrate consumption for this meal.

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

No Intervention: Extended morning fast

Participants will extend their overnight fast until the ad libitum lunch is provided.

Outcome Measures

Primary Outcome Measures

  1. Postprandial glycaemia following breakfast [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 [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 [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 [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 Outcome Measures

  1. Postprandial incretin hormone response following breakfast [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 [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 [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 [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 [For 3 hours following breakfast]

    Fat and carbohydrate oxidation following each type of breakfast

  6. Fuel oxidation following ad libitum lunch [For 2 hours following the ad libitum lunch]

    Fat and carbohydrate oxidation following ad libitum lunch

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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%)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Bath Bath Somerset United Kingdom BA2 7AY

Sponsors and Collaborators

  • University of Bath

Investigators

  • Principal Investigator: Harry A Smith, MSci, University of Bath
  • Principal Investigator: James A Betts, PhD, University of Bath

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
James Betts, Professor James Betts, University of Bath
ClinicalTrials.gov Identifier:
NCT03866720
Other Study ID Numbers:
  • DC-A
First Posted:
Mar 7, 2019
Last Update Posted:
Mar 4, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 4, 2021