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

Appetite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03866720
• Other study ID #: DC-A
• Status: Completed
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: February 17, 2021

Study information

• Verified date: March 2021
• Source: University of Bath
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 17, 2021
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Appetite
• Postprandial Metabolism

Intervention

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.

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.

Locations

Country	Name	City	State
United Kingdom	University of Bath	Bath	Somerset

Sponsors (1)

Lead Sponsor	Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Postprandial incretin hormone response following breakfast	The postprandial time course response of plasma incretin hormones (e.g. GLP-1 & GIP) to the each breakfast.	Plasma insulin time course data over 3 hours following breakfast
Secondary	Postprandial incretin hormone response following ad libitum lunch	The postprandial time course response of plasma incretin hormones (e.g. GLP-1 & GIP) to the ad libitum lunch following each type of breakfast	Plasma incretin time course data over 3 hours following breakfast
Secondary	Subjective appetite ratings following 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.	For 3 hours following each breakfast
Secondary	Subjective appetite ratings following 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.	For 3 hours following the ad libitum lunch
Secondary	Fuel oxidation following breakfast	Fat and carbohydrate oxidation following each type of breakfast	For 3 hours following breakfast
Secondary	Fuel oxidation following ad libitum lunch	Fat and carbohydrate oxidation following ad libitum lunch	For 2 hours following the ad libitum lunch