Breakfast Size and Weight Loss in Overweight/Obese Adults

Wolfson Medical Center (WMC)

Status and phase: Unknown; Phase 3

Conditions: Obesity

Treatments: Behavioral: Control breakfast; Behavioral: Enriched breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT01332877

0029-11-WOMC

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adult
• male and female
• obese
• sedentary
• glucose intolerant/insulin resistant

Exclusion criteria

• pregnant/lactating
• malignancy
• taking weight loss medications
• know eating disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 1 patient group

enriched breakfast

Experimental group

Description:

high carbohydrate, high protein breakfast providing 600 kcal, 50% carbohydrate, 20% protein, 30% fat

Treatment:

Behavioral: Enriched breakfast

Behavioral: Control breakfast