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Completed

NCT Number: NCT04735783

Placebo Breakfast Consumption, Appetite and Food Intake

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University, Loughborough, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Typical whole-food breakfast

Dietary Supplement

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

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.

Primary outcomes

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

    Time frame: 195 minutes post-breakfast provision.

    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'.

Secondary outcomes

  1. Visual Analogue Scale for Subjective Ratings of Appetite

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

    Time-course of subjective ratings of hunger between breakfast provision and one hour after consuming lunch, measured using an appetite visual analogue scale. The scale is divided into subscales of different appetite perceptions including: hunger, fullness, desire to eat and prospective food consumption. Each subscale is rated on a 100mm scale (i.e. from 0 - 100), with a rating of 100 fully supporting the perception and a rating of 0 fully opposing the perception.

  2. Acylated ghrelin

    Time frame: Baseline, 60 minutes, 180 minutes post-breakfast provision.

    Time-course of acylated ghrelin plasma concentrations across experimental trials.

  3. Peptide tyrosine-tyrosine (PYY)

    Time frame: Baseline, 60 minutes, 180 minutes post-breakfast provision.

    Time-course of PYY plasma concentrations across experimental trials.

  4. Blood glucose concentration

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

    Time-course of blood glucose concentrations across experimental trials.

Sponsors and collaborators

Lead sponsor

Nottingham Trent University

Other

Collaborators

  • Loughborough University

Registry information

Official study title

Effect of the Perception of Breakfast Consumption on Appetite and Energy Intake in Healthy Males

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 3, 2021
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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