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临床试验/NCT01332877
NCT01332877Unknown3 期

The Effect of Breakfast Enriched With Protein and Carbohydrates on Weight Loss, Hunger, Satiety and Ghrelin in Overweight and Obese Adults

Wolfson Medical Center2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
3 期
入组人数
150
试验地点
2
主要终点
Weight loss

研究概览

简要总结

EFFECT OF HIGH CARBOHYDRATE AND HIGH PROTEIN BREAKFAST ON WEIGHT LOSS, GHRELIN, HUNGER AND CRAVING SCORES IN OBESE MEN AND WOMEN. D Jakubowicz, M Boaz, J Wainstein, O Froy

Background: Obesity underlying endocrine, metabolic and eating behaviour features promotes weight gain, increase of hunger, and carbohydrate (Carb) craving. Restrictive diets either in calories or Carb produce withdrawal effect, that further exacerbate Carb craving resulting in rapid return of obesity. Meal timing and composition has shown to play a pivotal role in appetite regulation through several hormonal systems such as ghrelin. The investigators hypothesized that to be successful; a weight loss strategy must change the hormonal environment to increase satiety while reducing hunger and craving.

Objectives: To assess weight loss, satiety, hunger, cravings and ghrelin response to two isocaloric diets. Additionally, these outcomes were measured in response to meal challenge.

Methods: In this randomized, treatment controlled clinical trial, 146 obese, sedentary adults with impaired glucose tolerance will be assigned to Low carb diet (LCHbd) or an isocaloric diet with a high carb, high protein breakfast (HCPbd),1400 kcal for women and 1600 kcal for men. LCHbd breakfast will provide 300 kcal with carb: protein: fat of 13:40:48. HCPbd breakfast will provide 600 kcal with 50:20:30. From baseline until week 16 participants will take part in a supervised weight loss diet, followed until week 32 by a maintenance period. Anthropometric measures, OGTT for glucose and insulin, VAS-measured hunger and satiety and Food Craving Inventory Analysis will be performed at baseline, week 16 and week 32.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male and female
  • sedentary
  • glucose intolerant/insulin resistant

排除标准

  • pregnant/lactating
  • malignancy
  • taking weight loss medications
  • know eating disorder

结局指标

主要结局

Weight loss

时间窗: 32 weeks

Change from baseline weight

次要结局

  • Hunger(32 weeks)
  • Satiety(32 weeks)
  • plasma ghrelin(32 weeks)

研究者

申办方类型
Other Gov

研究点 (2)

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