Placebo Breakfast Consumption, Appetite and Food Intake

NCT04735783 | Completed

• 1 other identifier: TS_Placebo_2019
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

Breakfast skipping; Energy intake; Energy balance; Appetite hormones; Placebo feeding

Outcome Measures

Primary Outcomes (1)

• Voluntary energy intake (Kilocalories) at a laboratory-based test lunch meal

  A laboratory-based meal consisting of pasta, tomato sauce and olive oil will be provided to participants in excess of expected consumption. Participants will be permitted 20 minutes to eat as much or as little as they desire, until 'comfortably full and satisfied'.

  195 minutes post-breakfast provision.

Secondary Outcomes (4)

• Visual Analogue Scale for Subjective Ratings of Appetite

  Baseline, 10 minutes, 30 minutes, 60 minutes, 120 minutes, 195 minutes, 215 minutes, 275 minutes post-breakfast provision.

• Acylated ghrelin

  Baseline, 60 minutes, 180 minutes post-breakfast provision.

• Peptide tyrosine-tyrosine (PYY)

  Baseline, 60 minutes, 180 minutes post-breakfast provision.

• Blood glucose concentration

  Baseline, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes post-breakfast provision.

Study Arms (3)

Very low-energy, viscous placebo breakfast

EXPERIMENTAL

Participants will consumed a viscous breakfast meal from a standard bowl with a standard spoon. The volume of the meal will be 5 mL/kg body mass, consisting of 15% (0.75 mL/kg body mass) low-energy flavoured squash, with the remainder made up of tap water. To thicken the solution and increase the perception of energy intake, 0.1 g/kg xanthan gum (a soluble fibre often used as a low-energy thickening agent) will be added and the mixture will be blended thoroughly. An additional 3 mL/kg tap water will be consumed as a drink alongside the meal in this trial.

Dietary Supplement: Placebo breakfast

Typical, whole-food breakfast

ACTIVE COMPARATOR

Participants will consume a standardised meal consisting of puffed rice cereal, semi-skimmed milk, white bread, seedless strawberry jam, and apple juice. This meal will provide 20% of estimated energy requirements, determined by multiplying estimated resting metabolic rate by a physical activity level of 1.6. A measured volume of tap water will be consumed alongside this meal, in order to match total water content of the typical whole-food breakfast to the very low-energy, viscous placebo breakfast.

Dietary Supplement: Typical whole-food breakfast

Water-only control

ACTIVE COMPARATOR

Participants will consume 8 mL/kg body mass of plain tap water to match the total water content of the typical whole-food breakfast and the very low-energy, viscous placebo breakfast.

Dietary Supplement: Water-only control

Interventions

Placebo breakfast DIETARY_SUPPLEMENT

Participants will consume a very low-energy, placebo breakfast meal, but will be unaware of its near complete absence of energy until the end of the study.

Very low-energy, viscous placebo breakfast

Typical whole-food breakfast DIETARY_SUPPLEMENT

Participants will consume a typical whole-food breakfast meal, equating to 20% of estimated energy requirements.

Typical, whole-food breakfast

Water-only control DIETARY_SUPPLEMENT

Participants will consume a volume of plain water to match the water content of the very low-energy placebo breakfast and the typical whole-food breakfast.

Water-only control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nottingham Trent University: lead
• Loughborough University: collaborator

Study Sites (2)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

Nottingham Trent University

Nottingham, NG11 8NS, United Kingdom

Location

Related Publications (11)

• 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.

  PMID: 32174286 BACKGROUND

• 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.

  PMID: 28952831 BACKGROUND

• 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.

  PMID: 26278005 BACKGROUND

• 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

• 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.

  PMID: 25970668 BACKGROUND

• 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.

  PMID: 27292940 BACKGROUND

• 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.

  PMID: 26653842 BACKGROUND

• 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.

  PMID: 21562233 BACKGROUND

• 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.

  PMID: 23672851 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

• 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.

  PMID: 34766208 DERIVED

MeSH Terms

Conditions

Obesity; Intermittent Fasting

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the obvious differences between the three breakfasts meals (viscous, jelly-like placebo breakfast, typical whole-food breakfast, water-only control), participants will be aware that the three trials are different. However, they will not be told that the placebo breakfast contains nearly no energy, and therefore, are blinded to this aspect of the study.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 3, 2021
• Study Start: January 28, 2020
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

GB (2)