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
  Purpose

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.


Condition Intervention Phase
Obesity
Behavioral: Enriched breakfast
Behavioral: Control breakfast
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Breakfast Enriched With Protein and Carbohydrates on Weight Loss, Hunger, Satiety and Ghrelin in Overweight and Obese Adults

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    Change from baseline weight


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: April 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: enriched breakfast
high carbohydrate, high protein breakfast providing 600 kcal, 50% carbohydrate, 20% protein, 30% fat
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

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant/lactating
  • malignancy
  • taking weight loss medications
  • know eating disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332877

Contacts
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

Locations
Israel
Wolfson Medical Center Recruiting
Holon, Israel, 58100
Contact: Daniela Jakubowicz, MD    972-50-810-5552    daniela.jak@gmail.com   
Principal Investigator: Daniela Jakubowicz, MD         
Sponsors and Collaborators
Wolfson Medical Center
  More Information

No publications provided

Responsible Party: Prof. Daniel Jakubowicz, E. Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01332877     History of Changes
Other Study ID Numbers: 0029-11-WOMC
Study First Received: April 7, 2011
Last Updated: April 8, 2011
Health Authority: Israel: Helsinki Committee

Keywords provided by Wolfson Medical Center:
Obesity
Weight loss
Ghrelin
Satiety
Hunger

Additional relevant MeSH terms:
Obesity
Overweight
Weight Loss
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 18, 2014