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Breakfast Size and Weight Loss in Overweight/Obese Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Wolfson Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01332877
First received: April 7, 2011
Last updated: April 8, 2011
Last verified: April 2011

April 7, 2011
April 8, 2011
April 2011
November 2011   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Change from baseline weight
Same as current
Complete list of historical versions of study NCT01332877 on ClinicalTrials.gov Archive Site
  • Hunger [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    VAS hunger scores
  • Satiety [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    VAS satiety scores
  • plasma ghrelin [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    change from baseline ghrelin
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • 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
Experimental: enriched breakfast
high carbohydrate, high protein breakfast providing 600 kcal, 50% carbohydrate, 20% protein, 30% fat
Interventions:
  • Behavioral: Enriched breakfast
  • Behavioral: Control breakfast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant/lactating
  • malignancy
  • taking weight loss medications
  • know eating disorder
Both
25 Years to 70 Years
Yes
Contact: Daniela Jakubowicz, MD 972-50-810-5552 daniela.jak@gmail.com
Contact: Julio Wainstein, MD 972-3-502-8716 vainstein@wolfson.health.gov.il
Israel
 
NCT01332877
0029-11-WOMC
Yes
Prof. Daniel Jakubowicz, E. Wolfson Medical Center
Wolfson Medical Center
Not Provided
Not Provided
Wolfson Medical Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP