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High Quality Protein for Assisting With Weight Loss (Egg_breakfast)

28. maj 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Lubbock, Texas, Forenede Stater, 79409
        • Texas Tech University - Department of Nutritional Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 44 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: Weight Loss Diet
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
Aktiv komparator: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: Weight Loss Diet
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of subjective satiety
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in body weight (kg)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 0
Difference of measurements between self report survey and objective results
Day 0
Self report of desire to lose weight and ideal weight
Tidsramme: Day 0
Day 0

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Texas Tech University

Samarbejdspartnere

American Egg Board

Efterforskere

  • Ledende efterforsker: Nikhil Dhurandhar, Chair of the Nutritional Sciences Department

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. august 2017

Primær færdiggørelse (Faktiske)

17. maj 2019

Studieafslutning (Faktiske)

17. maj 2019

Datoer for studieregistrering

Først indsendt

15. marts 2017

Først indsendt, der opfyldte QC-kriterier

15. marts 2017

Først opslået (Faktiske)

21. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TTU IRB2016-1137

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