Obesity Clinical Trial
Official title:
The Effect of Breakfast Enriched With Protein and Carbohydrates on Weight Loss, Hunger, Satiety and Ghrelin in Overweight and Obese Adults
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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