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临床试验/NCT05071170
NCT05071170已完成不适用

Satiety Responses and Oral Processing Characteristics of Commonly Consumed Meals

Clinical Nutrition Research Centre, Singapore1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Subsequent food intake post test meal

研究概览

简要总结

Rationale: Oral processing behaviours (i.e. eating rate, bite size, chews per bite, oral exposure time etc.) play a major role in food ingestion and digestion, and potentially influence satiation and satiety responses . Experimental studies showed that a prolonged mastication or a slower eating rate is associated with decreased food intake , and increased satiety response per kcal consumed. Therefore, one possible approach to control the intake and appetite is to encourage eating behaviour that slow the rate of food intake and enhance the onset of satiety. Texture led changes to oral processing behaviours could offer an exciting opportunity to adapt an individual's response to structure properties of the food being consumed in a way that maintains the associated eating experience and satiety from food intake.

However, no studies to date have investigated how differences in food processing influences food texture characteristics and oral processing behaviours, and subsequently impact on individuals' satiety responses and their subsequent food intake. The proposed study will examine the role of oral processing behaviours and/ or food processing (i.e. minimally processed, processed and ultra-processed) on satiety responses and the subsequent food intake

Objectives: The objectives of the study are to characterise the differences in oral processing behaviours (i.e. eating rate, bite size, chew per bite, oral exposure time etc.) and satiety responses of meals that differ in their degree of processing, and to further investigate how texture-based differences in oral processing behaviours modified by degree of food processing influence the satiety responses (fullness over the time) and subsequent food intake.

Study design: A total of 1 screening session (Session 1) and 4 test sessions (Sessions 2 to 5) and 2x2 randomised crossover design where participants receive 4 treatments (i.e. 4 test meals) over 4 test sessions

Study population: Healthy males ( n=50), aged 21-50 years with BMI between 18-25 kg/m2

Intervention: Session 1 involves tasting of up to 16 food items and computer task to rate and evaluate their perception and health behaviour. Sessions 2 to 5 involve evaluation of sensory characteristics, video recording of participants eating, and wrist-worn accelerometer to track wrist movement while consuming the 4 test meals.

详细描述

Objectives:

The objectives of the study are to characterise the differences in oral processing behaviours (i.e. eating rate, bite size, chew per bite, oral exposure time etc.) and satiety responses of meals that differ in their degree of processing, and to further investigate how texture-based differences in oral processing behaviours modified by degree of food processing (i.e. un-, minimally-processed, processed and ultra-processed foods) influence the satiety responses (fullness over the time) and subsequent food intake.

Study Design:

The current study will require participants to attend a total of 5 study sessions involving 1 screening session (session 1) and 4 test sessions (sessions 2 to 5). Each session will last for approximately one to 1.5 hours (Screening), or 1.5 to 3 hours each (4 test sessions), respectively. maximum of 50 participants will be recruited for this study.

The perceived sensory, oral processing behaviours, and satiety responses across different meals (e.g. rice with meat and vegetable, meat with potato and salad, etc.) will be assessed using video recording, sensory and appetite assessment on 100mm Visual Analogue Scale (VAS), respectively. The subsequent food intake at the ad libitum snack for different meals will also be measured using a Sartorius balance. The dietary behaviour, perception and portion selection of foods varying in level of processing and nutrient sources will also be evaluated using a Health Behaviour Questionnaire and a simple computerised task.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy male
  • Aged between 21 and 50-year-old
  • Are of normal weight (BMI 18-25kg/m2)
  • Stable weight for the previous 12 months (<5kg weight fluctuation in the previous year)
  • Healthy dentition and ability to bite, chew and swallow normally
  • No history of pain or discomfort in jaw movements or excessive teeth clenching or grinding
  • No caries or periodontal disease

排除标准

  • Are a smoker
  • Have any dislikes, intolerances or allergies to foods or common food ingredients e.g. nuts, soya, wheat, gluten, cereal, fruits, biscuits, dairy products, rice, vegetable, meat, seafood, sugar and sweetener, gelatin, natural food colourings or flavourings (e.g. MSG), etc.
  • Have any specific dietary requirements and/ or restrictions (e.g. Vegan/ vegetarian, religious beliefs, lactose intolerance, calorie restricted diet etc.)
  • Have sinus problems that affect your taste and smell
  • Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Are taking insulin or medication known to affect your appetite or metabolism
  • Have major chronic diseases such as heart disease, cancer or diabetes mellitus
  • Have active Tuberculosis (TB) or currently receiving treatment for TB
  • Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
  • Are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
  • Are enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC

结局指标

主要结局

Subsequent food intake post test meal

时间窗: During test session 5, up to 0000hrs

Participants will be asked to bring a food dairy home to record their food and beverage intake for the rest of the test day. This is to assess participants' calorie intake for the remaining day on the test session.

Change in Post lunch satiety responses Session 5

时间窗: During test session 5, 15 or 30 minutes' intervals, up to 2 hours each

Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.

Oral processing behaviour

时间窗: During test session 5, Up to 20 minutes

Participants will be video-recorded during the lunch sessions to measure oral processing behaviour (e.g., derived from number of bites, chews, swallows and eating duration) of the test fixed portion test meals using an annotation software.

Change in Post breakfast satiety responses

时间窗: During test session 5, at 15 or 30 minutes' intervals, up to 4 hours each

Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.

Change in Post lunch satiety responses

时间窗: During test session 4, 15 or 30 minutes' intervals, up to 2 hours each

Participants will be asked rate their appetite sensations using a visual analogue scale (VAS) pre- and post meals. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.

次要结局

未报告次要终点

研究者

发起方
Clinical Nutrition Research Centre, Singapore
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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