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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
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Other: Arm 1 Breakfast Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of High Calorie Breakfast vs High Calorie Dinner on Weight Loss, Circulating Insulin, Ghrelin and Appetite Scores in Obese Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas Caracas:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 96
Study Start Date: June 2012
Estimated Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Breakfast Diet
The arm 1 will be assigned to eat High calorie breakfast (700kcal) and reduced dinner (200 kcal)
 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 2: Dinner Diet
In the Dinner diet will consume reduced breakfast (200 cal) and high calorie dinner (700 cal)
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623648

Locations
Venezuela
Daniela Jakubowicz
Caracas, San Bernardino, Venezuela, 410
Sponsors and Collaborators
Hospital de Clinicas Caracas
Investigators
Principal Investigator: Daniela Jakubowicz, MD Hospital de Clinicas Caracas
  More Information

No publications provided

Responsible Party: Daniela Jakubowicz, MD, MD, Hospital de Clinicas Caracas
ClinicalTrials.gov Identifier: NCT01623648     History of Changes
Other Study ID Numbers: HCCCBI 017-2007-104
Study First Received: June 18, 2012
Last Updated: January 18, 2013
Health Authority: Venezuela: Ethics Committee

Keywords provided by Hospital de Clinicas Caracas:
BD
DD

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 18, 2013