Placebo Breakfast Consumption, Appetite and Food Intake

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-28

Study Completion Date

2020-12-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Certain Breakfasts on Appetite Control

NCT02111486

Appetite Post-prandial Glucose Response

WITHDRAWN NA

Impact of ß-glucan Supplementation on Subjective Appetite and Gastrointestinal Appetite Hormones.

NCT05981404

Overweight and Obesity

UNKNOWN NA

Effects of Pre-exercise Carbohydrate Restriction Relative to Fasting on Metabolism, Appetite, and Energy Intake in Healthy Males.

NCT05107583

Obesity Metabolic Syndrome

COMPLETED NA

The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight

NCT02012426

Overweight Obesity Sedentary Lifestlye

COMPLETED NA

Effect of Exercise With or Without Breakfast, on Metabolism, Appetite and Cognition

NCT01229345

Energy Balance, Appetite, Cognitive Function.

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Very low-energy, viscous placebo breakfast

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.

Group Type EXPERIMENTAL