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临床试验/NCT00776256
NCT00776256已完成不适用

The Effect of Meal Replacement Bars Containing Different Types of Fibres (Oligofructose and/or Barley) on Satiety and Energy Intake

Unilever R&D2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年2月1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
24
试验地点
2
主要终点
Satiety and food intake

研究概览

简要总结

The effect of beta-glucan or fructo-oligosaccharide or their combination in bars on satiety and food intake was tested by supplying these bars on two consecutive days.

详细描述

Background: Increasing gastro-intestinal viscosity or colonic fermentation is suggested to help improve appetite control and reduce food intake. Beta-glucan (BG) and fructo-oligosaccharide (FOS) are food ingredients proposed to act this way, but results so far remain inconclusive.

Objective

To test the effect of FOS, BG, or their combination in bars on appetite ratings and food intake during 2 consecutive days.

Design: In a 4-way balanced order cross-over double-blind design, 21 healthy volunteers (mean BMI 25.9 kg/m2) received a meal replacement bar at 09.00h and an ad libitum lunch at 13.00h on 2 consecutive days. On day 1 only, subjects consumed a second (identical) bar at 17.00h and a fixed snack at 19.00h. The control bar contained 0.3g BG (control, from 6.8 g oats), vs equi-caloric bar formulations containing an additional: 1) 0.9 g BG (from 8.0g barley), 2) 8g FOS, or 3) 0.9 g BG + 8g FOS. Appetite scores and subsequent ad libitum test meal intakes were measured. Bar viscosities were determined under simulated gastric conditions. Results were analyzed using ANCOVA.

Results: Addition of BG, FOS or their combination did not affect appetite ratings or food intake, although addition of BG to the bar doubled apparent gastric viscosity (841 vs 351 mPa.s).

Conclusions: BG, FOS or their combination in bars at these levels do not improve appetite control when consumed on 2 consecutive days. Efficacy might be increased by a longer exposure period, increasing the BG content, or a form of BG that generates even higher gastric viscosity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age at start of the study 18 till 60 years
  • Quetelet-Index (BMI) from 21 till 32 kg/m2 inclusive
  • Apparently healthy: measured by questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders
  • Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian, macro-biotic or biologic dynamic food habits
  • No Fibre supplements (only once a day)
  • No blood donations during the study.
  • Reported intense sporting activities less than 10h/w
  • Reported alcohol consumption less than 21 units/w (female volunteers) or less than 28 units/w (male volunteers)
  • Having a General Practitioner
  • Informed consent signed
  • Recruitment form filled out

排除标准

  • Dislike, allergy/intolerance or not known with the foods of the ad libitum meal
  • Possible eating disorder (measured by SCOFF questionnaire)
  • High or very high restrained eaters (measured by questionnaire) (men with BMI < 27: restraint score > 2.37, men with BMI less than 27: restraint score > 3.04, women with BMI < 26: restraint score > 3.24, women with BMI less than 26: restraint score > 3.41)
  • Reported medical treatment that may affect eating habits/satiety
  • Reported intolerance or allergy to test products
  • Women reported lactating (or lactating < 6 weeks ago), pregnant (or pregnant < 3 months ago) or wish to become pregnant during the study
  • Reported weight loss/gain (10%) in the last six month before the trial
  • Reported participation in another biomedical trial 1 month before the start of the study
  • Reported working on late turns -

结局指标

主要结局

Satiety and food intake

时间窗: 2 days each week for 4 weeks

次要结局

未报告次要终点

研究者

发起方
Unilever R&D
申办方类型
Industry

研究点 (2)

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