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Clinical Trials/NCT01332877
NCT01332877UnknownPhase 3

The Effect of Breakfast Enriched With Protein and Carbohydrates on Weight Loss, Hunger, Satiety and Ghrelin in Overweight and Obese Adults

Wolfson Medical Center1 site in 1 country150 target enrollmentStarted: April 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Enrollment
150
Locations
1
Primary Endpoint
Weight loss

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

enriched breakfast

Experimental

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

Intervention: Enriched breakfast (Behavioral)

enriched breakfast

Experimental

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

Intervention: Control breakfast (Behavioral)

Outcomes

Primary Outcomes

Weight loss

Time Frame: 32 weeks

Change from baseline weight

Secondary Outcomes

  • Hunger(32 weeks)
  • Satiety(32 weeks)
  • plasma ghrelin(32 weeks)

Investigators

Sponsor Class
Other Gov

Study Sites (1)

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