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临床试验/NCT02258750
NCT02258750终止不适用

Experimental Study to Investigate the Effect of a High Fibre, Polydextrose-enriched Tomato Soup on Food Intake, the Experience of Appetite and Biomarkers of Satiation and Satiety

University of Liverpool1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
42
试验地点
1
主要终点
Reductions in caloric intake at subsequent ad libitum meals after polydextrose-enriched soup intake

研究概览

简要总结

This study will examine the impact of a soluble fibre (polydextrose) incorporated into a high fibre tomato soup on food intake (amount and choice), appetite ratings and biomarkers of satiation and satiety over 4-weeks. Specifically, the impact on the development of satiation within the fixed-load tomato soup containing the fibre, the development of satiety after the fixed-load meal containing fibre and intake at subsequent ad libitum meals will be examined as well as the insulin response and carbohydrate fermentation before and after 4-week dosing of the preload soup.

详细描述

The science underpinning both short (episodic) and long (tonic) term appetite regulation demonstrates that foods higher in macronutrients such as fibre can, under certain experimental conditions, produce great decreases in feelings of hunger and increases in fullness, post consumption, compared to equi-caloric loads of high carbohydrate or high fat. Given that fibre increases the release of GLP-1, slows down gastric emptying, prolongs nutrient absorption and, over long-term use increases the generation of short chain fatty acids (SCFAs) which have been linked to improved satiety responding, it is plausible that it will produce strong effects on within meal processes of satiation and satiety over the short- and long-term. Fibre has also been suggested to influence carbohydrate fermentation (via generation of these SCFAs) and improve the insulin response, additionally improving satiety. Ingredients may be added to boost fibre content such as the use of polydextrose, which is a non-digestible polysaccharide usually used as a dietary fibre in foods. Polydextrose has also been shown to increase levels of SCFAs due to its slow fermentation and has been related to reductions in subsequent intake and/or reduced hunger.

The aim of the current study is to assess the impact of a high fibre, polydextrose enriched tomato soup (experimental) or a low fibre tomato soup (control) on food intake, the experience of appetite and biomarkers of satiation and satiety.

Sample size: 86 males aged between 18 and 55 years with a body mass index (BMI) of between 23.0 and 28.0 kg/m2. A subset of 28 participants will undergo additional finger prick blood glucose and hydrogen breath test measures to assess biomarkers of satiation and satiety. Power calculations to ensure sufficient participants are included were based on power expected for a medium effect (0.25) at 80% power for a 2 condition between-measures design using G*power.

Methods: Participants will be invited to three full test day (baseline control, session 1; first dosing, session 2; one day prior to final dosing, session 3) sessions in which they will be provided with breakfast (tailored to individual resting metabolic rate (RMR) using the Schofield equation), the preload condition (receiving a high fibre polydextrose enriched or control tomato soup) one hour before an ad-libitum lunch and followed four hours later by an ad-libitum dinner and snack box. All test days will involve the use of standard operating proceedures. Pre-packaged portions of soup will be provided for a 4-week dosing period between study sessions 2 and 3 for all participants.

A subset of participants (N=28) will additionally undergo 3 further testing sessions (baseline control, session 0; second dosing, session 3; final dosing, session 4) in which a breakfast will be provided followed by the test product with additional glucose and carbohydrate fermentation measures collected for 3 hours before a light fixed portion meal.

研究设计

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •BMI of 23-28 kg/m2
  • •Not dieting within the last month and not having lost significant amount of weight in the previous year.
  • •Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study
  • •Able to eat most everyday foods
  • •Breakfast eaters
  • •Soup consumers
  • •Written informed consent to be given

排除标准

  • •Those with significant health problems
  • •BMI < 23.0 kg/m2 or > 28.0 kg/m2
  • •Participants who self-report dieting currently or within the last month or having lost a significant amount of weight over the previous 6 months.
  • •Volunteers who have significantly changed their physical activity patterns in the past 2-4 weeks or who intend to change them during the study
  • •Gastrointestinal symptoms requiring treatment.
  • •Smokers or those who have recently ceased smoking (including electric cigarettes).
  • •Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters.
  • •Participants who work in the following areas: Nutrition, Dietetics, Food Research, Food Manufacturing or Supplements Industry.
  • •Participants currently adhering to any specific food avoidance diets such as Atkins, the South Beach diet or low Glycaemic Index (GI).
  • •Participants who have had bariatric surgery for weight control or other reason.
  • •Non breakfast eaters.
  • •Those reporting a history of anaphylaxis to food, significant general food allergies or specific allergies to any of the study foods.
  • •Participants with abnormal eating behaviour

研究组 & 干预措施

Control

Placebo Comparator

Tomato soup without added polydextrose

干预措施: Control (Other)

Polydextrose

Experimental

Tomato soup enriched with added polydextrose

干预措施: Polydextrose (Dietary Supplement)

结局指标

主要结局

Reductions in caloric intake at subsequent ad libitum meals after polydextrose-enriched soup intake

时间窗: 90 minutes

Calorie intake at ad-libitum lunch, dinner, and evening snack pack intake

More stable blood glucose response immediately after and after 4-week dosing of high fibre polydextrose enriched tomato soup compared to control

时间窗: 180 minutes

Finger prick blood glucose measures pre- (12:00pm), post-soup intake (12:15pm) and at 15 min and 30 min intervals for 3 hours post-intake (12:30pm, 12:45pm, 1:00pm, 1:30pm, 2:00pm, 2:30pm, 3:00pm, 3:30pm, 4:00pm, 4:30pm, 5:00pm)

Larger short chain fatty acid fermentation of carbohydrate after 4-week dosing of high fibre polydextrose enriched tomato soup compared to control

时间窗: 180 minutes

Hydrogen breath test measures pre- (12:00pm), post-soup intake (12:15pm) and at 15 min and 30 min intervals for 3 hours post-intake (12:30pm, 12:45pm, 1:00pm, 1:30pm, 2:00pm, 2:30pm, 3:00pm, 3:30pm, 4:00pm, 4:30pm, 5:00pm)

次要结局

  • Changes in subjective experience of satiation after ingestion of high fibre polydextrose enriched tomato soup compared to control(30 minutes)
  • Changes in subjective experience of appetite and palatability in polydextrose tomato soup compared to control(60 minutes)

研究者

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

Dr. Una Masic

Post-Doctoral Associate

University of Liverpool

研究点 (1)

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