Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

High Quality Protein for Assisting With Weight Loss (Egg_breakfast)

28 maggio 2019 aggiornato da: Texas Tech University

Does Higher Protein Quality Reduce Energy Intake When Following a Weight Loss Diet Plan? -- Nonpilot, Powered Crossover

The purpose of this study is to determine if, in presence of a reduced calorie diet, a breakfast containing high quality protein source (eggs) would be more effective in reducing hunger and increasing feeling of fullness compared to a breakfast containing a lower quality of protein, but equal energy density. A previous pilot study with the same endpoints yielded borderline significant results; this study has been powered based on that pilot to interrogate our hypotheses.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This will be a crossover study with 2 experiments. Subjects will follow a reduced energy weight loss diet of 1,200-1,500 kcal adjusted to each individual's body weight for totally 2 weeks in each experiment. They will come to the clinic from day 1 to day 7 and consume egg breakfast (EB) for 5 days under our supervision. Then on weekends during this period they will continue this breakfast at home based on our advice. The next week they will have cereal breakfast (CB) and the process is similar to that in the first week.

The 1st experiment will test the satiety from egg breakfast (EB) and following energy intake in both lunch and dinner, compared with CB (cereal breakfast). Lunch and dinner will be offered on 2 test days during each week. Anthropometric and body composition measurements, blood pressure, blood draw, satiety questionnaire, as well as energy intake will also be collected in the 2 test days and compared between 2 breakfast groups.

The 2nd one is to test whether EB will help in resisting the intake of foods considered tempting, but detrimental to weight loss efforts, compared with CB. The process is similar to experiment 1 except no blood draw, no dinner offered. Instead, a tempting food after lunch will be offered.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Texas
      • Lubbock, Texas, Stati Uniti, 79409
        • Texas Tech University - Department of Nutritional Sciences

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 44 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Overweight and class I-II obese (BMI 25.0-39.9)
  • Sedentary (<3 hours/week of moderate intensity physical activity)
  • Otherwise healthy

Exclusion Criteria:

  • ≥5% body weight loss or gain in the three months preceding the study
  • Post-menopausal (has not had period for 12 months)
  • Plans to begin an exercise program or change current exercise routines between initiation of study and final study
  • Anyone following a medical diet prescription
  • Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type
  • Health conditions and chronic illness that contraindicate behavioral weight loss treatment using a low calorie diet: Unstable cardiac condition; Polycystic ovary syndrome; Prader-Willi syndrome; Major systemic illness; History of recreational drug abuse or eating disorder (Binge Eating Disorder); Familial hyperlipidemia; Major endocrine diseases (Cushing's syndrome, Grave's disease, Hashimoto's thyroiditis); Gastrointestinal disorder
  • Anyone who is currently pregnant, or lactating
  • Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling
  • Plans to begin taking any supplements that may influence weight loss
  • Report of medical condition or surgical intervention that affects swallowing or chewing ability
  • Anyone with a pacemaker or other internal medical device
  • Any practicing vegans or vegetarians
  • Any practicing gluten-free diet
  • Allergy, aversion, or dislike to any of the foods offered for meals

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Egg Breakfast (EB)

The EB will receive the following breakfast:

2 scrambled eggs, 120 mL skim milk, 2 slices of Mrs. Bairds® Extra Thin White Bread, 5 g of butter, and 18 g of Smuckers® Strawberry Jam.
Comportamentale: Egg breakfast (EB)
Breakfast is considered as high quality protein diet, but has similar weight, energy, and macronutrients as the active comparator. The details are as follows: weight 291 g,energy 400 kcal, energy density 1.37 kcal/g, carbohydrate 42.9%, fat 35.6%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 100, leucine 1.77 g, glycemic load 24, fiber 1.0 g.
Comportamentale: Weight Loss Counseling
Weight loss counseling will be administered by a Registered Dietitian and will utilize information and materials derived from the Evidence Analysis Library (EAL) of the Academy of Nutrition and Dietetics (AND). Topics will include portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, as well as behavioral strategies including self-monitoring, motivational interviewing, goal setting, and problem solving.
Comportamentale: Weight Loss Diet
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
Comparatore attivo: Cereal Breakfast (CB)

The CB will receive the following breakfast:

1.5 cups of Special K® Ready-to-Eat Original Cereal, 200 ml Silk® Original Soymilk, 1 slice of Nature's Own® Double Fiber Wheat Bread, 13 g of butter, and 10 g of Smuckers® Sugar-Free Strawberry Jam.
Comportamentale: Weight Loss Counseling
Weight loss counseling will be administered by a Registered Dietitian and will utilize information and materials derived from the Evidence Analysis Library (EAL) of the Academy of Nutrition and Dietetics (AND). Topics will include portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, as well as behavioral strategies including self-monitoring, motivational interviewing, goal setting, and problem solving.
Comportamentale: Weight Loss Diet
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
Comportamentale: Cereal Breakfast (CB)
Breakfast is considered as low quality protein diet, but has similar weight, energy, and macronutrients as that in experimental group. The details are as follows: weight 293 g, energy 398 kcal, energy density 1.36 kcal/g, carbohydrate 44.8%, fat 35.4%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 42, leucine 0.48 g, glycemic load 30.8, fiber 4.4 g.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of subjective satiety
Lasso di tempo: Change in scores (arbitrary units AUC) from 30 minutes before breakfast consumption to 240 minutes after the consumption on day 7 and day 14
This will be measured by questionnaire (VAS) and compared the changes between 2 test days (day 7 and day 14) in experiment 1&2
Change in scores (arbitrary units AUC) from 30 minutes before breakfast consumption to 240 minutes after the consumption on day 7 and day 14
Change of objective satiety
Lasso di tempo: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14
It is measured by GLP-1. This will be tested in experiment 1 and changes will be compared between 2 test days.
Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14
Change of objective satiety
Lasso di tempo: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
It is measured by PYY 3-36. This will be tested in experiment 1 and changes will be compared between 2 test days.
Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Change of objective satiety
Lasso di tempo: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
It is measured by ghrelin. This will be tested in experiment 1 and changes will be compared between 2 test days.
Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Other change of hormone level
Lasso di tempo: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
It is measured by serum glucose. This will be tested in experiment 1 and changes will be compared between 2 test days.
Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Other change of hormone level
Lasso di tempo: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
It is measured insulin levels. This will be tested in experiment 1 and changes will be compared between 2 test days.
Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Energy intake (kcal) during ad libitum lunch
Lasso di tempo: Test day 7 and day 14
Energy intake will be compared between 2 test days in experiment 1
Test day 7 and day 14
Energy intake (kcal) during ad libitum dinner
Lasso di tempo: Test day 7 and day 14
Energy intake will be compared between 2 test days in experiment 1
Test day 7 and day 14
Energy intake (kcal) during ad libitum lunch
Lasso di tempo: Test day 7 and day 14
Chocolate brownies will be added to the test lunch. Energy intake will be compared between 2 test days in experiment 2
Test day 7 and day 14

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in body weight (kg)
Lasso di tempo: Day 0, day 7 and day 14
Body weight change from baseline to day 7, and change from day 7 to day 14 will be compared
Day 0, day 7 and day 14
Change in waist and hip circumference (cm)
Lasso di tempo: Day 0, day 7 and day 14
Waist and hip circumference change from baseline to day 7, and change from day 7 to day 14 will be compared
Day 0, day 7 and day 14
Change in blood pressure (mm Hg)
Lasso di tempo: Day 0, day 7 and day 14
BP change from baseline to day 7, and change from day 7 to day 14 will be compared
Day 0, day 7 and day 14
Change in fat mass and lean body mass percentage
Lasso di tempo: Day 0, day 7 and day 14
Body fat change from baseline to day 7, and change from day 7 to day 14 will be compared
Day 0, day 7 and day 14
Self report bias in weight, height and body fat percentage
Lasso di tempo: Day 0
Difference of measurements between self report survey and objective results
Day 0
Self report of desire to lose weight and ideal weight
Lasso di tempo: Day 0
Day 0

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Texas Tech University

Collaboratori

American Egg Board

Investigatori

  • Investigatore principale: Nikhil Dhurandhar, Chair of the Nutritional Sciences Department

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 agosto 2017

Completamento primario (Effettivo)

17 maggio 2019

Completamento dello studio (Effettivo)

17 maggio 2019

Date di iscrizione allo studio

Primo inviato

15 marzo 2017

Primo inviato che soddisfa i criteri di controllo qualità

15 marzo 2017

Primo Inserito (Effettivo)

21 marzo 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 maggio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2019

Ultimo verificato

1 maggio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TTU IRB2016-1137

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi