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High Quality Protein for Assisting With Weight Loss (Egg_breakfast)

28 de maio de 2019 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Texas
      • Lubbock, Texas, Estados Unidos, 79409
        • Texas Tech University - Department of Nutritional Sciences

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 44 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: Weight Loss Diet
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
Comparador Ativo: 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.
Comportamental: 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.
Comportamental: Weight Loss Diet
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change of subjective satiety
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in body weight (kg)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: Day 0
Difference of measurements between self report survey and objective results
Day 0
Self report of desire to lose weight and ideal weight
Prazo: Day 0
Day 0

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Texas Tech University

Colaboradores

American Egg Board

Investigadores

  • Investigador principal: Nikhil Dhurandhar, Chair of the Nutritional Sciences Department

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de agosto de 2017

Conclusão Primária (Real)

17 de maio de 2019

Conclusão do estudo (Real)

17 de maio de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

15 de março de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de março de 2017

Primeira postagem (Real)

21 de março de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de maio de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de maio de 2019

Última verificação

1 de maio de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • TTU IRB2016-1137

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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