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临床试验/NCT02090049
NCT02090049已完成不适用

Appetite Ratings, Postprandial Glucose, Insulin and Gastrointestinal Hormone Responses After the Intake of an Enriched Fiber and Protein Breakfast Soft Bread in Healthy Adults

Puratos2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Puratos
入组人数
30
试验地点
2
主要终点
MEASUREMENT OF POSTPRANDIAL APPETITE RATINGS CHANGES

研究概览

简要总结

The aim of this study is to evaluate the appetite rating of a soft bread with a high content of fibre and protein (Puravita Breakfast®) as well as its capacity to modulate postprandial levels of glucose, insulin and gastrointestinal hormones involved in appetite control and insulin secretion in healthy adult volunteers.

详细描述

A total of 30 healthy adults (17 males and 13 females) ranging from 19 to 32 years old (mean age 25 ± 1), with a body mass index (BMI) ranging from 19.2 to 28.5 (mean BMI 23.3 ± 0.5) (normal to moderately overweight) participated in this study. To avoid the risk of reaching false conclusions, psychometric validations of food restrictions were determined for all subjects using the revised version of the Three Factor Eating Questionnaire.

This study was carried out according to EFSA requirements [Blundell et al., 2010]. The subjects were instructed to refrain from alcohol and/or from performing difficult physical activities 48 h prior to each test day. The evening before the test day, the subjects consumed a standardised dinner supplied by the study team. The meal consisted of pizza and pineapple juice (800 kcal: protein 18%E, fat 22%E and carbohydrate 60%E). The subjects were instructed to not eat or drink anything other than half a litre of water after the dinner.

After 20 min of resting, on the first day of intervention, anthropometric measurements (weight, height and waist circumference) were collected on subjects wearing only underwear and after emptying their bladder. On each day of the study, a fasting blood sample was acquired after the resting time, and appetites were assessed with a visual analogue scale (VAS).

The subjects were instructed to consume the tested breakfast (the soft roll bread or the control bread plus jam and margarine) within 10 min and were allowed to drink 150 ml of water. The subjects immediately completed two VASs, one on meal palatability and another on appetite feelings. In addition, the appetite feeling VAS was repeated every 30 min until a total of 4 h had passed.

The subjects were not allowed to eat or drink anything else during the 4 h of the intervention. They were allowed to read, study, talk or listen to quiet music, but they were not allowed to sleep. After the last blood extraction (4 h), an ad libitum lunch consisting of a standardised spaghetti Bolognese (17%E protein, 34%E fat and 49%E carbohydrate) and water (300 ml) was provided. The subjects were instructed to eat until comfortably satisfied. Food intake was registered by differences in spaghetti weight before and after lunch, and the energy intake was calculated afterwards. After the ad libitum lunch, the subjects completed two VASs, one on meal palatability and another on appetite feelings. The participants completed a 48-h dietary survey diary, including the food intake during the day before and the day of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

MEASUREMENT OF POSTPRANDIAL APPETITE RATINGS CHANGES

时间窗: 0, 30, 60, 90, 120, 180, 210 and 240 min after intervention

The behavioural markers of appetite satiation and satiety can be estimated by using two categories of behavioural parameters: subjective sensations and food consumption: * Motivation to eat or subjective sensations: by determining appetite-related self-reports include a range of measures intended to capture, over a given period, specific somatic sensations or perceived general state of hunger/repletion, motivation (desire) to eat (in general or specific food types), or prospective judgments of the quantity of food or specific foods types that could or would be eaten (Blundell et al., 2010) using 100 mm visual analogue scales (VAS) (FLint et al., 2000). * Food intakes by determining the quantity of food consumed as measured in the laboratory by means of well-controlled protocols can be considered to be an objective measure of appetite (De Graaf et al., 2004).

次要结局

  • Determination of postprandial glycaemia, insulinaemmia and physiological markers of satiation and satiety(0, 30, 60, 90, 120, 180, 210 and 240 min after intervention)

研究者

发起方
Puratos
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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