Clinical trial NCT04735783: Placebo Breakfast Consumption, Appetite and Food Intake
Official title: Effect of the Perception of Breakfast Consumption on Appetite and Energy Intake in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Breakfast skipping
Energy intake
Energy balance
Appetite hormones
Placebo feeding
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
Collaborators: name: Loughborough University
First posted: 2021-02-03
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study design is a randomised, controlled, crossover design in which participants undertake three dietary conditions in a randomised order with at least a four day period in between trials.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study was to examine the effects of a very low-energy, viscous placebo breakfast meal on subjective appetite sensations during the morning, and food intake at lunch, compared to a typical whole-food breakfast meal and a water-only control. Participants will not be told that the placebo breakfast contains nearly no energy until the end of the study. The breakfasts will be provided in a randomised order, with a period of at least four days separating the trials. Blood samples will be taken before and after the breakfast is eaten to see how appetite-regulating proteins and blood sugars respond during the morning. Appetite questionnaires will also be completed throughout the morning, and a pasta-based lunch meal will be provided so that voluntary food intake can be measured.

Detailed description: Obesity is a risk factor for several chronic diseases, including type-2 diabetes, heart disease and some forms of cancer. There is clear evidence demonstrating that weight gain occurs progressively over the lifespan, highlighting that preventative action should be taken by young, lean individuals, who may yet develop overweight or obesity later in life. A positive energy imbalance, in which energy intake exceeds energy expenditure for a sustained duration, is known to be the underlying systematic cause of obesity. Therefore, reducing daily energy intake is a seemingly simple solution to the this problem. However, compensatory alterations in appetite regulation which stimulate an increase in energy intake often impede the long-term success of such interventions.

Extending the overnight fasting period, thereby restricting the time available for food intake, has emerged as an effective dietary strategy for reducing daily energy intake and may assist with weight management. Laboratory studies have shown that skipping breakfast typically results in increased appetite during the morning, and an increase in energy intake at lunch. Therefore, the long-term success of skipping breakfast may be reduced by elevated appetite sensations. A recent study which aimed to assess the effects of a very-low energy, placebo breakfast on resistance exercise performance noted that appetite was suppressed after consuming the placebo, despite its lack of energy content. Whether this suppression of appetite following placebo breakfast consumption results in a reduced energy intake at lunch, is currently unknown. Therefore, the investigators are interested to examine the subjective and hormonal appetite responses to placebo breakfast consumption, compared with these responses to an overt breakfast consumption trial an overt breakfast skipping trial, and whether these changes result in any differences in voluntary energy intake at lunch.

The present study is a randomised, controlled, crossover study in which fourteen healthy, habitual breakfast-consuming (self-reported) males will consume a very low-energy, viscous placebo breakfast, a typically consumed, whole-food breakfast, and a water-only control. At least four days will separate trials.

Participants will firstly complete a pre-screening session in which anthropometric data will be collected. This will be used to determine the energy content of the typical whole-food breakfast.

Eligibility criteria: Inclusion Criteria:

* Non-smoker.
* Habitually consuming breakfast at least 3 days per week.
* Have maintained a stable weight for 6 months (self-reported).
* No known history of gastric, digestive, cardiovascular or renal disease.

Exclusion Criteria:

* Food allergies, dislike or intolerance of study foods or drinks.
* Not currently on a weight management program or have irregular eating patterns (i.e. extended fasting periods \>8h other than overnight - self reported).
* Use of medication that may affect hormone concentrations.
* Excessive alcohol consumption (\>4 units/day).
* Intensive training schedule (\>10 hours/week).

Primary outcomes:
measure: Voluntary energy intake (Kilocalories) at a laboratory-based test lunch meal
timeFrame: 195 minutes post-breakfast provision.
Secondary outcomes:
measure: Visual Analogue Scale for Subjective Ratings of Appetite
timeFrame: Baseline, 10 minutes, 30 minutes, 60 minutes, 120 minutes, 195 minutes, 215 minutes, 275 minutes post-breakfast provision.
measure: Acylated ghrelin
timeFrame: Baseline, 60 minutes, 180 minutes post-breakfast provision.
measure: Peptide tyrosine-tyrosine (PYY)
timeFrame: Baseline, 60 minutes, 180 minutes post-breakfast provision.
measure: Blood glucose concentration
timeFrame: Baseline, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes post-breakfast provision.
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
city: Nottingham
country: United Kingdom
facility: Nottingham Trent University
Study officials:
References:
citation: Naharudin MN, Adams J, Richardson H, Thomson T, Oxinou C, Marshall C, Clayton DJ, Mears SA, Yusof A, Hulston CJ, James LJ. Viscous placebo and carbohydrate breakfasts similarly decrease appetite and increase resistance exercise performance compared with a control breakfast in trained males. Br J Nutr. 2020 Mar 16:1-9. doi: 10.1017/S0007114520001002. Online ahead of print.
citation: Mears SA, Dickinson K, Bergin-Taylor K, Dee R, Kay J, James LJ. Perception of Breakfast Ingestion Enhances High-Intensity Cycling Performance. Int J Sports Physiol Perform. 2018 Apr 1;13(4):504-509. doi: 10.1123/ijspp.2017-0318. Epub 2018 May 14.
citation: Chowdhury EA, Richardson JD, Tsintzas K, Thompson D, Betts JA. Effect of extended morning fasting upon ad libitum lunch intake and associated metabolic and hormonal responses in obese adults. Int J Obes (Lond). 2016 Feb;40(2):305-11. doi: 10.1038/ijo.2015.154. Epub 2015 Aug 17.
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.
citation: Clayton DJ, Barutcu A, Machin C, Stensel DJ, James LJ. Effect of Breakfast Omission on Energy Intake and Evening Exercise Performance. Med Sci Sports Exerc. 2015 Dec;47(12):2645-52. doi: 10.1249/MSS.0000000000000702.
citation: Betts JA, Chowdhury EA, Gonzalez JT, Richardson JD, Tsintzas K, Thompson D. Is breakfast the most important meal of the day? Proc Nutr Soc. 2016 Nov;75(4):464-474. doi: 10.1017/S0029665116000318. Epub 2016 Jun 13.
citation: Clayton DJ, James LJ. The effect of breakfast on appetite regulation, energy balance and exercise performance. Proc Nutr Soc. 2016 Aug;75(3):319-27. doi: 10.1017/S0029665115004243. Epub 2015 Dec 14.
citation: Astbury NM, Taylor MA, Macdonald IA. Breakfast consumption affects appetite, energy intake, and the metabolic and endocrine responses to foods consumed later in the day in male habitual breakfast eaters. J Nutr. 2011 Jul;141(7):1381-9. doi: 10.3945/jn.110.128645. Epub 2011 May 11.
citation: Levitsky DA, Pacanowski CR. Effect of skipping breakfast on subsequent energy intake. Physiol Behav. 2013 Jul 2;119:9-16. doi: 10.1016/j.physbeh.2013.05.006. Epub 2013 May 11.
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.
citation: Slater T, Mode WJA, Hough J, James RM, Sale C, James LJ, Clayton DJ. Effect of the perception of breakfast consumption on subsequent appetite and energy intake in healthy males. Eur J Nutr. 2022 Apr;61(3):1319-1330. doi: 10.1007/s00394-021-02727-5. Epub 2021 Nov 11.