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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 7, 2011
CompletedFirst Posted
Study publicly available on registry
April 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedApril 11, 2011
April 1, 2011
7 months
April 7, 2011
April 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight loss
Change from baseline weight
32 weeks
Secondary Outcomes (3)
Hunger
32 weeks
Satiety
32 weeks
plasma ghrelin
32 weeks
Study Arms (1)
enriched breakfast
EXPERIMENTALhigh carbohydrate, high protein breakfast providing 600 kcal, 50% carbohydrate, 20% protein, 30% fat
Interventions
high carbohydrate, high protein breakfast supplying 600 kcal as 50k% carbohydrate, 20% protein, 30% fat
Control breakfast providing 300 kcal, 13% carbohydrate, 40% protein, 48% fat
Eligibility Criteria
You may qualify if:
- adult
- male and female
- obese
- sedentary
- glucose intolerant/insulin resistant
You may not qualify if:
- pregnant/lactating
- malignancy
- taking weight loss medications
- know eating disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wolfson Medical Center
Holon, 58100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
April 7, 2011
First Posted
April 11, 2011
Study Start
April 1, 2011
Primary Completion
November 1, 2011
Last Updated
April 11, 2011
Record last verified: 2011-04