Skip to content

Breakfast Size and Weight Loss in Overweight/Obese Adults

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01332877
Enrollment
150
Registered
2011-04-11
Start date
2011-04-30
Completion date
Unknown
Last updated
2011-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Weight loss, Ghrelin, Satiety, Hunger

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.

Interventions

BEHAVIORALEnriched breakfast

high carbohydrate, high protein breakfast supplying 600 kcal as 50k% carbohydrate, 20% protein, 30% fat

Control breakfast providing 300 kcal, 13% carbohydrate, 40% protein, 48% fat

Sponsors

Wolfson Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Weight loss32 weeksChange from baseline weight

Secondary

MeasureTime frameDescription
Hunger32 weeksVAS hunger scores
Satiety32 weeksVAS satiety scores
plasma ghrelin32 weekschange from baseline ghrelin

Countries

Israel

Contacts

Primary ContactDaniela Jakubowicz, MD
daniela.jak@gmail.com972-50-810-5552
Backup ContactJulio Wainstein, MD
vainstein@wolfson.health.gov.il972-3-502-8716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026