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High Quality Protein for Assisting With Weight Loss (Egg_breakfast)

2019년 5월 28일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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.
행동: 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.
행동: Weight Loss Diet
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
활성 비교기: 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.
행동: 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.
행동: Weight Loss Diet
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change of subjective satiety
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in body weight (kg)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: Day 0
Difference of measurements between self report survey and objective results
Day 0
Self report of desire to lose weight and ideal weight
기간: Day 0
Day 0

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Texas Tech University

협력자

American Egg Board

수사관

  • 수석 연구원: Nikhil Dhurandhar, Chair of the Nutritional Sciences Department

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 8월 20일

기본 완료 (실제)

2019년 5월 17일

연구 완료 (실제)

2019년 5월 17일

연구 등록 날짜

최초 제출

2017년 3월 15일

QC 기준을 충족하는 최초 제출

2017년 3월 15일

처음 게시됨 (실제)

2017년 3월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 5월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 5월 28일

마지막으로 확인됨

2019년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TTU IRB2016-1137

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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아니

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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