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临床试验/NCT02012426
NCT02012426已完成不适用

The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight

University of Leeds2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
2
主要终点
Test Meal Energy Intake

研究概览

简要总结

The aim of the current study is to demonstrate that a commercial weight management diet (i.e. low energy density) influences satiation, hunger and satiety and leads to lower energy intake during ad-libitum meals and over a full day. We further seek to demonstrate the sustainability of this effect following 12- week weight loss on the weight management program.

  • We hypothesise that formulated (low energy) meals will lead to decreased hunger, greater fullness and reduced desire to eat compared to standard meals.
  • We hypothesise that the commercial weight management program will lead to greater weight loss compared to control program.
  • We hypothesise that formulated meals (high consumer acceptance) will improve hedonic control over eating (lower wanting for high fat food)
  • We hypothesise that the commercial weight management program will improve hedonic control over eating (reduced experience food cravings)

研究设计

研究类型
Interventional
分配方式
Non 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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI of 28 - 45 kg/m2
  • Reporting an interest in weight loss, not actively participating in a commercial weight loss program,
  • Not increased physical activity levels in the past 2-4 weeks
  • Able to eat most everyday foods and fruits and vegetables
  • Written informed consent to be given

排除标准

  • Significant health problems that could cause confounding effects between intervention and control.
  • Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
  • Pregnant, planning to become pregnant or breastfeeding
  • History of anaphylaxis to food
  • Known food allergies or food intolerance
  • Smokers and those who have recently ceased smoking
  • Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
  • Those who have previously taken part in a commercial weight loss program in the last 6 months? .
  • Participants who work in appetite or feeding related areas
  • Participants unable to consume foods used in the study
  • Participants who have had bariatric surgery
  • Participants with a history of eating disorder
  • Presence of untreated hypothyroidism
  • Inability to fully comply with intervention or study procedures
  • Insufficient English language skills to complete study questionnaires

结局指标

主要结局

Test Meal Energy Intake

时间窗: Week 0 and week 12

Measured reductions in ad-libitum energy intake following consumption of formulated test meal in comparison to control.

Food preference

时间窗: Week 0 and week 14

Measured changes in food preference and liking and wanting profiles for food (HF\<LF) following consumption of formulated test meal in comparison to equi-energetic control

24h Energy Intake

时间窗: Week 0 and week 12

Measured reduction in total within-day energy intake following consumption of formulated meals in comparison to control

Appetite sensations

时间窗: Week 0 and week 14

Measured reduction in hunger and increase in satiety quotient following consumption of formulated test meal in comparison to equi-energetic control

次要结局

  • Body Weight(Weekly from week 0 to week 12)

研究者

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

Dr Graham Finlayson

Principal Investigator

University of Leeds

研究点 (2)

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