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History of Changes for Study: NCT01571310
Effect of High Calorie Breakfast vs High Calorie Dinner on Weight Loss (BvsD)
Latest version (submitted October 10, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 4, 2012 None (earliest Version on record)
2 April 3, 2015 Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations, Study Identification, Eligibility, Study Design, Study Description, Conditions and Sponsor/Collaborators
3 June 2, 2015 Study Status
4 March 7, 2016 Study Status
5 October 10, 2017 Recruitment Status, Study Status and Study Design
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Study NCT01571310
Submitted Date:  April 4, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 0047-12-WOMC
Brief Title: Effect of High Calorie Breakfast vs High Calorie Dinner on Weight Loss (BvsD)
Official Title: Comparison of the Effect of High Calorie Breakfast Diet vs High Calorie Dinner Diet on Weight Loss, Ghrelin, Lipids and Appetite Scores in Obese Non-diabetic Women.
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2012
Overall Status: Active, not recruiting
Study Start: March 2012
Primary Completion: June 2012 [Anticipated]
Study Completion: July 2012 [Anticipated]
First Submitted: March 30, 2012
First Submitted that
Met QC Criteria:
April 4, 2012
First Posted: April 5, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 4, 2012
Last Update Posted: April 5, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Tel Aviv University
Responsible Party: Principal Investigator
Investigator: Daniela Jakubowicz
Official Title: Prof. Daniela Jakubowicz MD
Affiliation: Tel Aviv University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Compared to a low carbohydrate diet, an isocaloric diet with a calorie- protein- and carbohydrate-enriched breakfast which also included dessert, promoted sustained weight loss, prevention of weight regain, reduced hunger and cravings improved ghrelin suppression and compliance. We will investigate the effect of meal timing on weight loss, ghrelin plasma levels, hunger, satiety and craving scores by comparing during 12 weeks the outcome of 2 isocaloric diets that differ in meal timing distribution: a high calorie breakfast (HCB diet) vs. high calorie dinner (HCD diet) in overweight and obese women. The time frame is 12 weeks
Detailed Description:

In obesity, the underlying endocrine, metabolic and eating behavior promote weight gain, increase hunger and carbohydrate craving. Energy or carbohydrate restricted diets produce a withdrawal effect which further exacerbates carbohydrate craving and promotes rapid weight regain. Weight loss diets continue to be ineffective with only 5% success after 2 years, and almost virtually no success after 5 years.

In our recent study, Meal timing and composition influence ghrelin levels, appetite scores and weight loss maintenance in overweight and obese adults (Steroids 10;77(4):323-331, 2012), we demonstrated that compared to a low carbohydrate diet, an isocaloric diet with an energy, carbohydrate and protein-enriched breakfast which also included dessert, enhanced weight loss and prevented weight regain. This was associated with reduced hunger and cravings and increased ghrelin suppression. However the direct effects of meal timing (morning vs. evening consumption of carbohydrates) were not tested.

Objective: The present study is designed to address whether a change in meal timing; specifically, by adding calories, protein and carbohydrates to the morning vs. the evening meal, impacts weight loss, ghrelin plasma levels, serum lipids and appetite scores. Our hypothesis is that compared to a weight loss diet with reduced breakfast and high calorie dinner (HCDd), an isocaloric diet with a high calorie breakfast (HCBd) and reduced dinner will enhance weight loss, decrease ghrelin plasma levels and appetite scores in overweight and obese adults.

The present study is a randomized clinical trial. 90 overweight or obese (BMI: 25 to 35 kg/m2), females will be recruited for study participation. Subjects will be randomized to one of two isocaloric (1400 kcal) weight loss diets during 12 weeks: High Calorie Breakfast Diet (HCBd) or High Calorie Dinner Diet (HCDd). (Time Frame of both diets will be 12 weeks)

Open or close this module Conditions
Conditions: Obesity
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 90 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Lifestyle counseling HCB diet
This group of n= 45 obese will be assigned to High calorie-protein- and carbohydrate- enriched breakfast (HCBd) diet during 12 weeks
Lifestyle Counseling HCB diet:
In Experimental Lifestyle Counseling with HCB diet the obese subjetct n=45 will consume during 12 weeks a high calorie , protein and carbohydrate breakfast diet.Body weight will be measured every 2 weeks during the 12 weeks of the trial.
Active Comparator: HCD diet
In the Active Comparator HCD diet, the obese n= 45 subject will consume during 12 weeks a high calorie, protein and carbohydrate dinner, Body weight will be measured every 2 weeks during the 12 weeks of the trial.
Active Comparator: HCD diet
The HCD diet: the obese individuals assigned to HCD diet will consume high calorie, protein and carbohydrate dinner, during 12 weeks.
Lifestyle Counseling HCB diet:
In Experimental Lifestyle Counseling with HCB diet the obese subjetct n=45 will consume during 12 weeks a high calorie , protein and carbohydrate breakfast diet.Body weight will be measured every 2 weeks during the 12 weeks of the trial.
Active Comparator: HCD diet
In the Active Comparator HCD diet, the obese n= 45 subject will consume during 12 weeks a high calorie, protein and carbohydrate dinner, Body weight will be measured every 2 weeks during the 12 weeks of the trial.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in Body Weight
[ Time Frame: Change in Body weight every 2 weeks until week 12 ]

Body weight will be measured at baseline and every 2 weeks until week 12 at the end of the trial
Secondary Outcome Measures:
1. Plasma Ghrelin Levels
[ Time Frame: Ghrelin levels at baseline and after 12 weeks ]

Ghrelin plasma levels will be measured after breakfast and after dinner at baseline and after 12 week on diet
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: Female
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Julio Wainstein, MD
Study Director
Head of Diabetes Unit E. Wolfson Medical Center
Locations: Israel
Daniela Jakubowicz
Holon, Israel, 58100
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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