NCT01332877

Breakfast Size and Weight Loss in Overweight/Obese Adults

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Wolfson Medical Center · Other Government
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Enriched breakfast	high carbohydrate, high protein breakfast supplying 600 kcal as 50k% carbohydrate, 20% protein, 30% fat
BEHAVIORAL	Control breakfast	Control breakfast providing 300 kcal, 13% carbohydrate, 40% protein, 48% fat

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-11-01
• First posted: 2011-04-11
• Last updated: 2011-04-11

Locations

1 site across 1 country: Israel