跳至主要内容
临床试验/NCT01372683
NCT01372683已完成4 期

The Effect of Oat Based Breakfast Cereals on Satiety

PepsiCo Global R&D2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
96
试验地点
2
主要终点
Area under the curve (AUC) of appetite and satiety

研究概览

简要总结

This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density.

详细描述

This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density. Ninety-six healthy men and women 18 years of age or older will be enrolled into this study and divided into 2 groups of 48 each to investigate the satiety impact of two oat based breakfast cereals compared to the leading ready-to-eat (RTE) oat based breakfast cereal. Each subject will participate in two test sessions (1 test cereal vs the leading RTE cereal). Subjects will come to the Ingestive Behavior Laboratory between 8 and 10 am after having nothing to eat for 10 hours prior to the scheduled visit time and be given one of the three cereals. The second session will be scheduled at least 1 week after the first. Visual analogue scales of hunger, satiety and subjective energy will be completed at baseline, 30, 60, 120, 180, and 240 minutes. Subjects will return on another day separated by at least a week to repeat the breakfast. Area under the curves of appetite and satiety will be compared with a mixed model.

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

入排标准

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

入选标准

  • Male or female
  • 18 years of age or older
  • Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children

排除标准

  • Women who are pregnant or nursing
  • Gain or loss of > 4kg in the last 3 months.
  • Diabetes mellitus (fasting glucose >126 mg/dL)
  • Dietary restraint on the Three Factor Eating Questionnaire score greater than or equal to 14
  • Allergy to any of the foods used for the test breakfasts (oats or milk)

结局指标

主要结局

Area under the curve (AUC) of appetite and satiety

时间窗: 4 hours

次要结局

  • Area under the curve for subjective energy measures(4 hours)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Oat Breakfast Satiety Study | 临床试验