Breakfast Size and Weight Loss in Overweight/Obese Adults
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Behavioral: Enriched breakfast Behavioral: Control breakfast |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Breakfast Enriched With Protein and Carbohydrates on Weight Loss, Hunger, Satiety and Ghrelin in Overweight and Obese Adults |
- Weight loss [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]Change from baseline weight
- Hunger [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]VAS hunger scores
- Satiety [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]VAS satiety scores
- plasma ghrelin [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]change from baseline ghrelin
| Estimated Enrollment: | 150 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: enriched breakfast
high carbohydrate, high protein breakfast providing 600 kcal, 50% carbohydrate, 20% protein, 30% fat
|
Behavioral: Enriched breakfast
high carbohydrate, high protein breakfast supplying 600 kcal as 50k% carbohydrate, 20% protein, 30% fat
Behavioral: Control breakfast
Control breakfast providing 300 kcal, 13% carbohydrate, 40% protein, 48% fat
|
Eligibility| Ages Eligible for Study: | 25 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- adult
- male and female
- obese
- sedentary
- glucose intolerant/insulin resistant
Exclusion Criteria:
- pregnant/lactating
- malignancy
- taking weight loss medications
- know eating disorder
Contacts and Locations| Contact: Daniela Jakubowicz, MD | 972-50-810-5552 | daniela.jak@gmail.com |
| Contact: Julio Wainstein, MD | 972-3-502-8716 | vainstein@wolfson.health.gov.il |
| Israel | |
| Wolfson Medical Center | Recruiting |
| Holon, Israel, 58100 | |
| Contact: Daniela Jakubowicz, MD 972-50-810-5552 daniela.jak@gmail.com | |
| Principal Investigator: Daniela Jakubowicz, MD | |
More Information
No publications provided
| Responsible Party: | Prof. Daniel Jakubowicz, E. Wolfson Medical Center |
| ClinicalTrials.gov Identifier: | NCT01332877 History of Changes |
| Other Study ID Numbers: | 0029-11-WOMC |
| Study First Received: | April 7, 2011 |
| Last Updated: | April 8, 2011 |
| Health Authority: | Israel: Helsinki Committee |
Keywords provided by Wolfson Medical Center:
|
Obesity Weight loss Ghrelin Satiety Hunger |
Additional relevant MeSH terms:
|
Obesity Weight Loss Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 21, 2013