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

Primary Purpose

Physical Activity, Postprandial Metabolism, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Carbohydrate Rich Breakfast
Whey protein enriched breakfast
Sponsored by
University of Bath
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Physical Activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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%)

Sites / Locations

  • University of Bath

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Carbohydrate rich breakfast

Whey protein enriched breakfast

Extended morning fast

Arm Description

Participants will be provided with 28-days worth of pre-weighed carbohydrate rich breakfast materials to consume before 1000h daily.

Participants will be provided with 28-days worth of pre-weighed whey protein enriched rich breakfast materials to consume before 1000h daily.

Participants will be asked to remain fasted (i.e. to not consume breakfast) until 1200h daily for 28-days.

Outcomes

Primary Outcome Measures

Change in physical activity thermogenesis
Energy expenditure measured using physical activity monitor
Change in expression of circadian clock genes measured in whole blood
Pre and post intervention change clock gene expression
Change in postprandial glycaemia following carbohydrate rich test breakfast and lunch over 4 weeks
The postprandial time course response of plasma glucose to the test breakfast and lunch meals
Change in postprandial insulinaemia following carbohydrate rich test breakfast and lunch over 4 weeks
The postprandial time course response of plasma insulin to the test breakfast and lunch meals
Change in body mass
Participants will be weighed prior to the intervention and again upon completion

Secondary Outcome Measures

Change in postprandial incretin hormone response following breakfast and lunch
The postprandial time course response of plasma incretin hormones (e.g. GLP-1 & GIP) to the the test breakfast.
Change in subjective appetite ratings following breakfast and lunch
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
Change in fuel oxidation during the test breakfast
Fat and carbohydrate oxidation following breakfast

Full Information

First Posted
March 5, 2019
Last Updated
April 15, 2023
Sponsor
University of Bath
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1. Study Identification

Unique Protocol Identification Number
NCT04417205
Brief Title
Isolating and Exploiting the Mechanisms That Link Breakfast and Human Health - Intervention
Official Title
Isolating and Exploiting the Mechanisms That Link Breakfast and Human Health - Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bath

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Postprandial Metabolism, Weight Loss

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomised to one of 3 intervention arms.
Masking
Participant
Masking Description
Where applicable (i.e. the two breakfast feeding interventions) participants will be blinded to the breakfast that they receive for 28-days.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbohydrate rich breakfast
Arm Type
Active Comparator
Arm Description
Participants will be provided with 28-days worth of pre-weighed carbohydrate rich breakfast materials to consume before 1000h daily.
Arm Title
Whey protein enriched breakfast
Arm Type
Experimental
Arm Description
Participants will be provided with 28-days worth of pre-weighed whey protein enriched rich breakfast materials to consume before 1000h daily.
Arm Title
Extended morning fast
Arm Type
No Intervention
Arm Description
Participants will be asked to remain fasted (i.e. to not consume breakfast) until 1200h daily for 28-days.
Intervention Type
Other
Intervention Name(s)
Carbohydrate Rich Breakfast
Intervention Description
Participants will be asked to consume the provided carbohydrate rich breakfast before 1000h daily for 28 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein enriched breakfast
Intervention Description
Participants will be asked to consume the provided whey protein enriched breakfast before 1000h daily for 28 days.
Primary Outcome Measure Information:
Title
Change in physical activity thermogenesis
Description
Energy expenditure measured using physical activity monitor
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.
Title
Change in expression of circadian clock genes measured in whole blood
Description
Pre and post intervention change clock gene expression
Time Frame
Baseline and 4-weeks
Title
Change in postprandial glycaemia following carbohydrate rich test breakfast and lunch over 4 weeks
Description
The postprandial time course response of plasma glucose to the test breakfast and lunch meals
Time Frame
Baseline and 4-weeks
Title
Change in postprandial insulinaemia following carbohydrate rich test breakfast and lunch over 4 weeks
Description
The postprandial time course response of plasma insulin to the test breakfast and lunch meals
Time Frame
Assessed at baseline and after 4 weeks of the intervention
Title
Change in body mass
Description
Participants will be weighed prior to the intervention and again upon completion
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in postprandial incretin hormone response following breakfast and lunch
Description
The postprandial time course response of plasma incretin hormones (e.g. GLP-1 & GIP) to the the test breakfast.
Time Frame
Baseline and 4 weeks
Title
Change in subjective appetite ratings following breakfast and lunch
Description
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
Time Frame
Baseline and 4 weeks
Title
Change in fuel oxidation during the test breakfast
Description
Fat and carbohydrate oxidation following breakfast
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry A Smith, MSci
Organizational Affiliation
University of Bath
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James A Betts, PhD
Organizational Affiliation
University of Bath
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bath
City
Bath
State/Province
Somerset
ZIP/Postal Code
BA2 7AY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23446906
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.
Results Reference
background
PubMed Identifier
25733634
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.
Results Reference
background
PubMed Identifier
25733459
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.
Results Reference
background
PubMed Identifier
26864365
Citation
Chowdhury EA, Richardson JD, Holman GD, Tsintzas K, Thompson D, Betts JA. The causal role of breakfast in energy balance and health: a randomized controlled trial in obese adults. Am J Clin Nutr. 2016 Mar;103(3):747-56. doi: 10.3945/ajcn.115.122044. Epub 2016 Feb 10.
Results Reference
background
PubMed Identifier
24898233
Citation
Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults. Am J Clin Nutr. 2014 Aug;100(2):539-47. doi: 10.3945/ajcn.114.083402. Epub 2014 Jun 4.
Results Reference
background

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

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