Breakfast Size and Weight Loss in Overweight/Obese Adults

April 8, 2011 updated by: Wolfson Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel, 58100
        • Recruiting
        • Wolfson Medical Center
        • Principal Investigator:
          • Daniela Jakubowicz, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 32 weeks
Change from baseline weight
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hunger
Time Frame: 32 weeks
VAS hunger scores
32 weeks
Satiety
Time Frame: 32 weeks
VAS satiety scores
32 weeks
plasma ghrelin
Time Frame: 32 weeks
change from baseline ghrelin
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Estimate)

April 11, 2011

Last Update Submitted That Met QC Criteria

April 8, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0029-11-WOMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Enriched breakfast

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe