High Calorie Breakfast Versus Dinner on Weight Loss, Ghrelin and Appetite in Obese Women (BDvsDD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daniela Jakubowicz, MD, Hospital de Clinicas Caracas
ClinicalTrials.gov Identifier:
NCT01623648
First received: June 18, 2012
Last updated: January 18, 2013
Last verified: January 2013

June 18, 2012
January 18, 2013
June 2012
November 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01623648 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
High Calorie Breakfast Versus Dinner on Weight Loss, Ghrelin and Appetite in Obese Women
Effect of High Calorie Breakfast vs High Calorie Dinner on Weight Loss, Circulating Insulin, Ghrelin and Appetite Scores in Obese Women

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
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
  • Active Comparator: Arm 1 Breakfast Diet
    The arm 1 will be assigned to eat High calorie breakfast (700kcal) and reduced dinner (200 kcal)
    Intervention: Other: Arm 1 Breakfast Diet
  • Active Comparator: Arm 2: Dinner Diet
    In the Dinner diet will consume reduced breakfast (200 cal) and high calorie dinner (700 cal)
    Intervention: Other: Arm 1 Breakfast Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
96
January 2013
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects ≥18 and ≤75 years of age
  2. Overweight or obese (BMI: 25 to 35 kg/m2)
  3. Interested and willing to lose weight during the study and provides signed informed consent
  4. Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months
  5. Stable physical activity pattern during the three months immediately preceding study initiation
  6. Normal liver and kidney function
  7. Fasting blood glucose <110 mg/dl.
  8. No metabolic disease
  9. Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00.
  10. Normal TSH and FT4 levels
  11. Acceptable health based on interview, medical history, physical examination, and laboratory tests

Exclusion Criteria:

  1. Diabetes mellitus or impaired fasting glucose defined by medical history or fasting glucose > 110 mg/dl
  2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
  3. Serum creatinine level > 1.5 mg/dl
  4. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
  5. Any physiologic or mechanical problems preventing dietary adherence
  6. Pregnant or lactating
  7. Participating in another dietary program or use of weight-loss medications
  8. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
  9. Use of psychotropic or anoretic medication during the month immediately prior to study onset
  10. Night or rotating shift work
  11. Jet lag during the 2 week period immediately prior to study onset

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Female
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Venezuela
 
NCT01623648
HCCCBI 017-2007-104
Yes
Daniela Jakubowicz, MD, Hospital de Clinicas Caracas
Hospital de Clinicas Caracas
Not Provided
Principal Investigator: Daniela Jakubowicz, MD Hospital de Clinicas Caracas
Hospital de Clinicas Caracas
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP