- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01332877
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
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Holon, Israel, 58100
- Rekruttering
- Wolfson medical center
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Ledende efterforsker:
- Daniela Jakubowicz, MD
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Kontakt:
- Daniela Jakubowicz, MD
- Telefonnummer: 972-50-810-5552
- E-mail: daniela.jak@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- adult
- male and female
- obese
- sedentary
- glucose intolerant/insulin resistant
Exclusion Criteria:
- pregnant/lactating
- malignancy
- taking weight loss medications
- know eating disorder
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: enriched breakfast
high carbohydrate, high protein breakfast providing 600 kcal, 50% carbohydrate, 20% protein, 30% fat
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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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Weight loss
Tidsramme: 32 weeks
|
Change from baseline weight
|
32 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hunger
Tidsramme: 32 weeks
|
VAS hunger scores
|
32 weeks
|
Satiety
Tidsramme: 32 weeks
|
VAS satiety scores
|
32 weeks
|
plasma ghrelin
Tidsramme: 32 weeks
|
change from baseline ghrelin
|
32 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0029-11-WOMC
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