Role of Visual Cues in the Regulation of Portion Size and the Cephalic Satiety Response in Lean and Overweight Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Bite size difference (men)
研究概览
简要总结
Randomised within subjects cross-over study (n=94) exploring the cognitive and physiological processes associated with portion control. Participants will eat a self-served lunch using a portion control plate vs. a conventional (control) plate on two separate occasions under a controlled laboratory environment. Portion size, meal micro-structure, attention, memory and satiety markers will be analysed. The portion control plate is a prototype designed in collaboration with the commercial partner for this study and is based on published evidence. It includes sectors and pictures indicating amounts to serve from starchy food, protein and vegetables. The control plate will be of the same background colour, size and shape but without any pictures or demarcations. The main study outcome is attention time on areas of interest in the plate corresponding to main foods groups, across plate conditions.
详细描述
The size and design of tableware have been proposed as a potentially effective strategy to modulate how much is eaten at a meal. The mechanisms by which specific tableware may work however are not known, in particular the cognitive processes associated with visual stimuli. In this covert trial, 68 women (34 overweight or obese) and 26 lean men (exploratory sub-study) will self-serve and consume food from a laboratory buffet using a portion control plate with visual stimuli for appropriate amounts of main food groups, or a conventional plate, on two different days in random order. On both sessions participants will complete behavioural and cognitive tests to measure visual attention during the meal (eyetracking device), meal microstructure (Universal Eating Monitor), episodic memory for portion sizes (computerised test), portion size choice, food intake, subjective appetite and satiety, cephalic and intestinal satiety responses. Further behavioural tests include meal liking, expected satiety, portion size perceptions and tool acceptance ratings. The main study outcome is difference in proportional dwell time on areas of interest in the plate corresponding to main foods groups (women), or difference in bite size (men) across conditions. Secondary outcomes for all subjects include: portion size for overall meal and meal components, eating rate, bite size, deceleration rate, portion size memory error, portion size norms, portion control self-efficacy, tool acceptance, energy compensation for the rest of the day, plus blood insulin, glucose, pancreatic polypeptide and ghrelin up to 90 min post-meal (sub-sample of 34 women, 50% being overweight/obese). Analyses by gender and BMI sub-groups will be applied when possible. The results of this study will help to better understand the potential mechanisms by which portion control tools with visual cues may work, and to improve the design of current instruments for their application in nutritional interventions.
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
- None
盲法说明
Masking is not possible due to the nature of the intervention (portion control vs. conventional plate).
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men aged 18-60 years.
- •For women, having a BMI between 18.5 and 35 kg/m2 (both included); for men having a BMI between 18.5 and 25 kg/m2 (both included).
- •Healthy as determined from the self-reported medical history or when a clinical condition exists, when this is considered to be irrelevant for the study by the study medical doctor.
- •Not taking any medication that may affect sight, gastro-intestinal function or appetite. Volunteers taking medication for clinical conditions that may affect the above functions will be eligible if they report no side effects and the dose has been stable for at least 3 months prior to commencement of the study.
- •Consuming breakfast and lunch regularly (at least 5 days per week).
- •Liking of the study foods defined by a score of >40 mm of the Liking VAS questionnaire, for each compulsory meal component.
- •Able to consume food without the need for prescription glasses (contact lenses are allowed).
- •Able to understand and be willing to sign the informed consent form and to follow all the study procedures and requirements.
排除标准
- •Deficient nutrition or hydration status at the time of recruitment.
- •Abnormal gastro-intestinal function or structure such as malformation, angiodysplasia, active peptic ulcer, and chronic inflammatory or malabsorptive diseases, even if at the time of recruitment the volunteer is not taking medication for such conditions (e.g. anti-inflammatory drugs).
- •History of gastro-intestinal surgery with permanent sequels (i.e. gastroduodenostomy).
- •History of liver disease.
- •History of cancer or receiving treatment for cancer.
- •Diabetes mellitus.
- •Food allergy, food restriction or avoidance of any of the study foods (e.g. vegetarian).
- •History of mental illness, or being under active treatment for mental illness (e.g. psychiatric disorder), whenever their condition affects their ability to comprehend or follow the requirements of the study in full, or when their condition affects short-term memory (e.g. Alzheimer disease).
- •Presence of an eating disorder defined as a score >19 on the Eating Attitudes Test (EAT-26).
- •Diagnosed or suspected epilepsy or photosensitive epilepsy (e.g. experiencing an "aura" or odd sensations while watching images or patterns on a computer screen).
- •Wearing a pacemaker or other medical electronic device.
- •Currently dieting to lose weight.
- •Smoking > 7 cigarettes per week.
- •Consuming >14 units of alcohol intake per week in women, or >21 units per week in men.
- •Performing >9 h of intense physical activity per week.
- •Pregnancy or lactation.
- •Having received formal portion size education as part of a university degree (e.g. Dietetics, Human Nutrition, Psychology if relevant).
- •Being familiar with the nature of the covert measures involved in the study (i.e. measure of eating speed and bite size).
- •Volunteers for which insufficient collaboration may be foreseen, or whom the investigator has grounds to believe that they may experience difficulty in following the study procedures.
结局指标
主要结局
Bite size difference (men)
时间窗: Month 24
Difference in the amount of food loaded on the fork estimated from the difference in grams between two consecutive weight records as measured by the Universal Eating Monitor, between the Portion Control Plate condition and the conventional plate condition.
Dwell time difference (women)
时间窗: Month 24
Difference in proportional dwell time on three areas of interest in the plate corresponding to main food groups i.e. starch, protein and vegetables, measured in milliseconds, as a proxy for attention levels, between the Portion Control Plate condition and the conventional plate condition.
次要结局
- Difference in expected satiation for the meal(Month 24)
- Baseline blood insulin(Month 21)
- Eating rate difference(Month 24)
- Percent memory reconstruction error difference(Month 24)
- Percent energy compensation (EC)(Month 21)
- Difference in portion size at meal(Month 24)
- Portion size norms difference(Month 24)
- 3 h subjective nausea(Month 21)
- Difference in subjective appetite and satiety scores(Month 24)
- Baseline blood glucose(Month 21)
- Difference in post-meal blood glucose(Month 21)
- Difference in portion tool acceptance(Month 24)
- Food intake for remaining of the day(Month 21)
- Bite size difference (women)(Month 24)
- Percent memory reconstruction error (conventional plate)(Month 21)
- Portion size norms(Month 21)
- Baseline subjective nausea(Month 21)
- 3 h subjective satiety(Month 21)
- Difference in post-meal blood ghrelin(Month 24)
- Body Mass Index(Month 18)
- Self-reported ethnicity(Month 18)
- Home-made meal consumption(Month 18)
- Meal duration difference(Month 24)
- Dwell time difference (men)(Month 24)
- Baseline subjective appetite(Month 21)
- Percent memory reconstruction error (Portion Control Plate)(Month 21)
- Percent energy compensation difference(Month 24)
- Liking for the meal differences(Month 24)
- Baseline subjective satiety(Month 21)
- Baseline subjective thirst(Month 21)
- Post-meal subjective nausea(Month 21)
- 3 h subjective appetite(Month 21)
- Post-meal blood glucose(Month 21)
- Deceleration rate difference(Month 24)
- Post-meal subjective appetite(Month 21)
- Post-meal subjective satiety(Month 21)
- Post-meal subjective thirst(Month 21)
- 3 h subjective thirst(Month 21)
- Post-meal blood pancreatic polypeptide(Month 21)
- Difference in post-meal blood pancreatic polypeptide(Month 24)
- Eating behaviour profile from the Three Factor Eating Questionnaire (TFEQ)(Month 21)
- Eating behaviour profile from the Eating Attitudes Test (EAT-26)(Month 18)
- Cooking pattern(Month 18)
- Post-meal blood insulin(Month 21)
- Difference in post-meal blood insulin(Month 24)
- Baseline blood pancreatic polypeptide(Month 21)
- Household composition(Month 18)
- Previous experience with portion tools(Month 18)
- Baseline blood ghrelin(Month 21)
- Post-meal blood ghrelin(Month 21)
- Age(Month 18)
- Difference in portion control self-efficacy(Month 24)
- Take away food consumption(Month 18)