Breakfast Size and Weight Loss in Overweight/Obese Adults

Phase 3

• Conditions: Obesity
• Interventions: Behavioral: Enriched breakfast; Behavioral: Control breakfast

• Registration Number: NCT01332877
• Lead Sponsor: Wolfson Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study Start: 2011-04
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-08
• Last Update Submitted: 2011-04-08
• Study First Posted: 2011-04-11
• Last Update Posted: 2011-04-11
• Primary Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enriched breakfast	Enriched breakfast	high carbohydrate, high protein breakfast providing 600 kcal, 50% carbohydrate, 20% protein, 30% fat
enriched breakfast	Control breakfast	high carbohydrate, high protein breakfast providing 600 kcal, 50% carbohydrate, 20% protein, 30% fat

Primary Outcome Measures

Name	Time	Method
Weight loss	32 weeks	Change from baseline weight

Secondary Outcome Measures

Name	Time	Method
Hunger	32 weeks	VAS hunger scores
Satiety	32 weeks	VAS satiety scores
plasma ghrelin	32 weeks	change from baseline ghrelin

Trial Locations

Locations (1)

Wolfson Medical Center; 🇮🇱 Holon, Israel