Breakfast Size and Weight Loss in Overweight/Obese Adults
NCT ID: NCT01332877
Last Updated: 2011-04-11
Study Results
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Basic Information
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UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2011-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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enriched breakfast
high carbohydrate, high protein breakfast providing 600 kcal, 50% carbohydrate, 20% protein, 30% fat
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* male and female
* obese
* sedentary
* glucose intolerant/insulin resistant
Exclusion Criteria
* malignancy
* taking weight loss medications
* know eating disorder
25 Years
70 Years
ALL
Yes
Sponsors
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Wolfson Medical Center
OTHER_GOV
Responsible Party
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E. Wolfson Medical Center
Locations
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Wolfson Medical Center
Holon, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0029-11-WOMC
Identifier Type: -
Identifier Source: org_study_id
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