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

NCT03866720 | Completed

• 1 other identifier: DC-A
• Study Type: interventional
• Target: 12
• 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 crossover design) of a wider project.

Conditions

Postprandial Metabolism; Appetite

Outcome Measures

Primary Outcomes (4)

• Postprandial glycaemia following breakfast

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

  Plasma glucose time course data over 3 hours following breakfast

• Postprandial insulinaemia following breakfast

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

  Plasma insulin time course data over 3 hours following breakfast

• Postprandial glycaemia following ad libitum lunch

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

  Plasma glucose time course data over 2 hours following lunch

• Postprandial insulinaemia following ad libitum lunch

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

  Plasma insulin time course data over 2 hours following lunch

Secondary Outcomes (6)

• Postprandial incretin hormone response following breakfast

  Plasma insulin time course data over 3 hours following breakfast

• Postprandial incretin hormone response following ad libitum lunch

  Plasma incretin time course data over 3 hours following breakfast

• Subjective appetite ratings following breakfast

  For 3 hours following each breakfast

• Subjective appetite ratings following ad libitum lunch

  For 3 hours following the ad libitum lunch

• Fuel oxidation following breakfast

  For 3 hours following breakfast

Study Arms (3)

Carbohydrate rich breakfast

ACTIVE COMPARATOR

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

Other: Carbohydrate rich breakfast

Whey protein enriched breakfast

EXPERIMENTAL

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

Dietary Supplement: Whey protein enriched breakfast

Extended morning fast

NO INTERVENTION

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

Interventions

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.

Carbohydrate rich breakfast

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.

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)

• Chowdhury EA, Richardson JD, Tsintzas K, Thompson D, Betts JA. Carbohydrate-rich breakfast attenuates glycaemic, insulinaemic and ghrelin response to ad libitum lunch relative to morning fasting in lean adults. Br J Nutr. 2015 Jul 14;114(1):98-107. doi: 10.1017/S0007114515001506. Epub 2015 May 25.

  PMID: 26004166 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

• 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

• 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

• Smith HA, Watkins JD, Walhin JP, Gonzalez JT, Thompson D, Betts JA. Whey Protein-Enriched and Carbohydrate-Rich Breakfasts Attenuate Insulinemic Responses to an ad libitum Lunch Relative to Extended Morning Fasting: A Randomized Crossover Trial. J Nutr. 2023 Oct;153(10):2842-2853. doi: 10.1016/j.tjnut.2023.08.008. Epub 2023 Aug 7.

  PMID: 37557957 DERIVED

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 trials) participants will be blinded to the breakfast that they receive.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor James Betts

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: February 26, 2019
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

GB (1)