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临床试验/NCT04735783
NCT04735783已完成不适用

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

Nottingham Trent University4 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
4
主要终点
Voluntary energy intake (Kilocalories) at a laboratory-based test lunch meal

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

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

时间窗: 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'.

次要结局

  • Peptide tyrosine-tyrosine (PYY)(Baseline, 60 minutes, 180 minutes post-breakfast provision.)
  • Acylated ghrelin(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.)
  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tommy Slater

Principle Investigator

Nottingham Trent University

研究点 (4)

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