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

NCT04417205 | Completed

• 1 other identifier: DC-I
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Postprandial Metabolism; Weight Loss

Outcome Measures

Primary Outcomes (5)

• Change in physical activity thermogenesis

  Energy expenditure measured using physical activity monitor

  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.

• Change in expression of circadian clock genes measured in whole blood

  Pre and post intervention change clock gene expression

  Baseline and 4-weeks

• 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

  Baseline and 4-weeks

• 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

  Assessed at baseline and after 4 weeks of the intervention

• Change in body mass

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

  4 weeks

Secondary Outcomes (3)

• Change in postprandial incretin hormone response following breakfast and lunch

  Baseline and 4 weeks

• Change in subjective appetite ratings following breakfast and lunch

  Baseline and 4 weeks

• Change in fuel oxidation during the test breakfast

  Baseline and 4 weeks

Study Arms (3)

Carbohydrate rich breakfast

ACTIVE COMPARATOR

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

Other: Carbohydrate Rich Breakfast

Whey protein enriched breakfast

EXPERIMENTAL

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

Dietary Supplement: Whey protein enriched breakfast

Extended morning fast

NO INTERVENTION

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

Interventions

Carbohydrate Rich Breakfast OTHER

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

Carbohydrate rich breakfast

Whey protein enriched breakfast DIETARY_SUPPLEMENT

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

Whey protein enriched breakfast

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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%)

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 23446906 BACKGROUND

• 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.

  PMID: 25733634 BACKGROUND

• 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.

  PMID: 25733459 BACKGROUND

• 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.

  PMID: 26864365 BACKGROUND

• 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.

  PMID: 24898233 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Harry A Smith, MSci

  University of Bath

  PRINCIPAL INVESTIGATOR

• James A Betts, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Where applicable (i.e. the two breakfast feeding interventions) participants will be blinded to the breakfast that they receive for 28-days.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor James Betts

Model Details: Participants will be randomised to one of 3 intervention arms.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: June 4, 2020
• Study Start: February 26, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

GB (1)