Breakfast Size and Weight Loss in Overweight/Obese Adults

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01332877
• Other study ID #: 0029-11-WOMC
• Status: Recruiting
• Phase: Phase 3
• First received: April 7, 2011
• Last updated: April 8, 2011
• Start date: April 2011

Study information

• Verified date: April 2011
• Source: Wolfson Medical Center
• Contact: Daniela Jakubowicz, MD
• Phone: 972-50-810-5552
• Email: daniela.jak[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Helsinki Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Enriched breakfast
high carbohydrate, high protein breakfast supplying 600 kcal as 50k% carbohydrate, 20% protein, 30% fat
• Control breakfast
Control breakfast providing 300 kcal, 13% carbohydrate, 40% protein, 48% fat

Locations

Country	Name	City	State
Israel	Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Change from baseline weight	32 weeks	No
Secondary	Hunger	VAS hunger scores	32 weeks	No
Secondary	Satiety	VAS satiety scores	32 weeks	No
Secondary	plasma ghrelin	change from baseline ghrelin	32 weeks	No