Breakfast Size and Weight Loss in Overweight/Obese Adults
Primary Purpose
Obesity
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Enriched breakfast
Control breakfast
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight loss, Ghrelin, Satiety, Hunger
Eligibility 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
Sites / Locations
- Wolfson Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
enriched breakfast
Arm Description
high carbohydrate, high protein breakfast providing 600 kcal, 50% carbohydrate, 20% protein, 30% fat
Outcomes
Primary Outcome Measures
Weight loss
Change from baseline weight
Secondary Outcome Measures
Hunger
VAS hunger scores
Satiety
VAS satiety scores
plasma ghrelin
change from baseline ghrelin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01332877
Brief Title
Breakfast Size and Weight Loss in Overweight/Obese Adults
Official Title
The Effect of Breakfast Enriched With Protein and Carbohydrates on Weight Loss, Hunger, Satiety and Ghrelin in Overweight and Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Weight loss, Ghrelin, Satiety, Hunger
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
enriched breakfast
Arm Type
Experimental
Arm Description
high carbohydrate, high protein breakfast providing 600 kcal, 50% carbohydrate, 20% protein, 30% fat
Intervention Type
Behavioral
Intervention Name(s)
Enriched breakfast
Intervention Description
high carbohydrate, high protein breakfast supplying 600 kcal as 50k% carbohydrate, 20% protein, 30% fat
Intervention Type
Behavioral
Intervention Name(s)
Control breakfast
Intervention Description
Control breakfast providing 300 kcal, 13% carbohydrate, 40% protein, 48% fat
Primary Outcome Measure Information:
Title
Weight loss
Description
Change from baseline weight
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Hunger
Description
VAS hunger scores
Time Frame
32 weeks
Title
Satiety
Description
VAS satiety scores
Time Frame
32 weeks
Title
plasma ghrelin
Description
change from baseline ghrelin
Time Frame
32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Jakubowicz, MD
Phone
972-50-810-5552
Email
daniela.jak@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Julio Wainstein, MD
Phone
972-3-502-8716
Email
vainstein@wolfson.health.gov.il
Facility Information:
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Jakubowicz, MD
Phone
972-50-810-5552
Email
daniela.jak@gmail.com
First Name & Middle Initial & Last Name & Degree
Daniela Jakubowicz, MD
12. IPD Sharing Statement
Learn more about this trial
Breakfast Size and Weight Loss in Overweight/Obese Adults
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