High Calorie Breakfast Versus Dinner on Weight Loss, Ghrelin and Appetite in Obese Women (BDvsDD)
| Tracking Information | |||||
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| First Received Date ICMJE | June 18, 2012 | ||||
| Last Updated Date | January 18, 2013 | ||||
| Start Date ICMJE | June 2012 | ||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Body Weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Subjects will be randomized to one of two isocaloric (1400 kcal) weight loss diets for 12 weeks: High Calorie Breakfast Diet BD or High Calorie Dinner Diet DD. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01623648 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Ghrelin suppression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] We will compare ghrelin supression after high calorie breakfast in the Breakfast Diet Group with ghrelin supression after high calorie dinner in the dinner diet group |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | High Calorie Breakfast Versus Dinner on Weight Loss, Ghrelin and Appetite in Obese Women | ||||
| Official Title ICMJE | Effect of High Calorie Breakfast vs High Calorie Dinner on Weight Loss, Circulating Insulin, Ghrelin and Appetite Scores in Obese Women | ||||
| Brief Summary | The investigators hypothesis is that comparing a Breakfast Diet (BD) which consist in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high calorie dinner with reduced breakfast; the BD would enhance weight loss, ghrelin suppression and appetite scores in obese women. |
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| Detailed Description | Recently we have shown that compared to low carbohydrate diet, an isocaloric diet with addition of high calorie breakfast that also included dessert, promoted sustained weight loss and prevented weight regain by reducing diet-induced compensatory changes in hunger, cravings and ghrelin suppression. However direct effects of meal timing (morning vs. evening increased calories) were not tested. To search whether a change in meal timing by increasing calories in the morning vs in the evening has a differential impact on weight loss, ghrelin suppression, lipids and appetite scores. Our hypothesis is that comparing the Breakfast Diet (BD) which consist in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high calorie dinner with reduced breakfast; the BD would enhance weight loss, ghrelin suppression and appetite scores. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Other: Arm 1 Breakfast Diet
The patients of the Arm 1 will be assigned to eat high calorie breakfast (700 kcal) and reduced dinner (200kcal)
Other Name: Breakfast Diet versus Dinner Diet |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 96 | ||||
| Estimated Completion Date | January 2013 | ||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Venezuela | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01623648 | ||||
| Other Study ID Numbers ICMJE | HCCCBI 017-2007-104 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Daniela Jakubowicz, MD, Hospital de Clinicas Caracas | ||||
| Study Sponsor ICMJE | Hospital de Clinicas Caracas | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hospital de Clinicas Caracas | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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