The Consumption of Beef on Appetite and Cognitive Function
2019년 4월 30일 업데이트: Heather Leidy, University of Missouri-Columbia
A Randomized Controlled Feeding, Crossover Trial to Assess the Appetitive and Cognitive Effects of Daily Beef Consumption in Healthy, Overweight Women
The purpose of the main study is to determine whether the daily consumption of protein-rich meals containing high quality, lean beef products improves appetite control and cognitive function during a weight maintenance diet.
The purpose of the sub-study is to determine whether the daily consumption of protein-rich meals containing the same amount of high quality, lean beef products improves appetite control and cognitive function during a modest energy restriction, weight loss diet.
연구 개요
상태
완전한
상세 설명
Two cross-over design studies were completed in overweight, sedentary but otherwise healthy women.
For study 1, 17 participants randomly consumed 4 eucaloric diets containing standard-protein (SP; 76±1g protein/d) or high-protein (HP; 126±1g protein/d) for 7 consecutive days/treatment.
The SP treatments contained all plant proteins (PLANT) or a combination of beef and plant proteins (BEEF) that were evenly distributed throughout the day (EVEN).
The HP treatments were also BEEF provided as EVEN or an uneven distribution (UNEVEN) pattern.
For study 2, 17 participants randomly consumed 3 energy restriction (1250 kcal/d) diets containing SP-PLANT (EVEN) and SP-BEEF (EVEN) (both, 48±1g protein/d) or HP-BEEF (EVEN) (123±1g protein/d).
During day 6 of each treatment (for both studies), the participants completed a 12-h controlled-feeding, clinical testing day which included repeated appetite, satiety, food cravings, and mood questionnaires; blood sampling; and cognitive function/performance testing.
During day 7 of each treatment (for both studies), the participants completed a free-living, ad libitum testing day at home/work to assess ad libitum (voluntary) daily intake and food choice.
Each of the 7-day dietary patterns occurred during the follicular phase of the menstrual cycle; thus, there were 2-3 week washout periods between dietary treatments.
연구 유형
중재적
등록 (실제)
35
단계
- 해당 없음
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:
- Women
- Ages: 18-52 y
- BMI: 25-32 kg/m2
- No metabolic, hormonal, and/or neural conditions/diseases that influence metabolism, appetite, or cognition
- No blood donations to American Red Cross within past 6 months
- No medication that would influence directly appetite or cognition
- No change in any medications (over the past 3 months)
- Non-smoking (for the past year)
- Not pregnant within the past 6 months (or planning to become pregnant during study)
- Have not given birth and/or lactating within the past 6 months
- Normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)
- Not clinically diagnosed with an eating disorder
- No weight loss/gain (≥10 lb. in the past 6 months)
- No past history of surgical interventions for the treatment of obesity
- No allergies and/or aversions to the study foods, particularly beef
- Consumes ≤ 800 mg caffeine/day
- Of this, ≤260 mg caffeine is consumed prior to lunch (~12 oz. Starbucks coffee)
- Not currently and/or previously on a specific diet including high protein, vegan, vegetarian, etc.
- Willing and able to consume all study foods
- Habitually consumes breakfast, lunch, and dinner >4 days/week
- No history of drug abuse or alcohol abuse (i.e., >14 drinks/week; 1 drink=12 oz. beer; 5 oz. wine; 1.5 oz. liquor)
- Displays a score of <4 on the Three Factor Eating Habits Questionnaire (TFEQ)
- Conventional (typical) and consistent sleep patterns
- awake hours somewhere between 5 am - 11 pm with no afternoon naps
- rates quality of sleep as Fairly to Very Good on the Pittsburg Sleep Quality Index (PSQI)
- averages ≥ 6 sleep hours/night over the past month
- Displays a Profile of Mood State 2nd Edition (POMS2; 60-item) Depression-Dejection Scale score within 1.5 SD of the age, gender, and racial-specific normative mean (Nyenhuis et al., 1999; Petterson K et al., 2006)
- Obtained a "Yes" on the validity indicator and displayed a score of >70 (>2%) on the CNS Vital Signs Battery
- Sedentary (i.e., limited purposeful physical activity)
- Willing and able to maintain current inactivity patterns throughout the study
- Willing and able to follow all study procedures
- Generally healthy, as assessed from the medical history questionnaire
Exclusion Criteria:
- Men
- Ages: <18 or >52 y
- BMI: <25 or >32 kg/m2
- Any metabolic, hormonal, and/or neural conditions/diseases that influence metabolism, appetite, or cognition
- Have donated blood to American Red Cross within past 6 months
- Medication that would influence directly appetite or cognition
- Change in medications (over the past 3 months)
- Have smoked in the past year
- Pregnant within the past 6 months (or planning to become pregnant during study)
- Have given birth and/or lactating within the past 6 months
- Abnormal menstrual cycles [not between 26-32 days in duration; or not 5-6 menstrual cycles within the past 6 months; or not able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)]
- Clinically diagnosed with an eating disorder
- Weight loss/gain (≥10 lb. in the past 6 months)
- Past history of surgical interventions for the treatment of obesity
- Allergies and/or aversions to the study foods, particularly beef
- Consumes > 800 mg caffeine/day
- Or, of caffeine consumed, >260 mg caffeine is consumed prior to lunch (~12 oz. Starbucks coffee)
- Currently and/or previously on a specific diet including high protein, vegan, vegetarian, etc.
- Unwilling and/or unable to consume all study foods
- Habitually consumes breakfast, lunch, and dinner <4 days/week
- History of drug abuse or alcohol abuse (i.e., >14 drinks/week; 1 drink=12 oz. beer; 5 oz. wine; 1.5 oz. liquor)
- Displays a score of >4 on the Three Factor Eating Habits Questionnaire (TFEQ)
- Unconventional (atypical) and/or inconsistent sleep patterns
- awake hours not somewhere between 5 am - 11 pm and/or afternoon naps
- does not rate quality of sleep as Fairly to Very Good on the Pittsburg Sleep Quality Index (PSQI)
- averages < 6 sleep hours/night over the past month
- Does not display a Profile of Mood State 2nd Edition (POMS2; 60-item) Depression-Dejection Scale score within 1.5 SD of the age, gender, and racial-specific normative mean (Nyenhuis et al., 1999; Petterson K et al., 2006)
- Did not obtain a "Yes" on the validity indicator and/or did not display a score of >70 (>2%) on the CNS Vital Signs Battery
- Not sedentary (i.e., purposeful physical activity)
- Unwilling and/or unable to maintain current inactivity patterns throughout the study
- Unwilling and/or unable to follow all study procedures
- Not generally healthy, as assessed from the medical history questionnaire
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Energy Balance Comparison
Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance. Interventions: Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN) |
Diet contains all plant proteins.
Meals are evenly distributed throughout the day.
Diet contains combination of beef and plant proteins.
Meals are evenly distributed throughout the day.
Diet contains combination of beef and plant proteins.
Meals are evenly distributed throughout the day.
Diet contains combination of beef and plant proteins.
Meals are unevenly distributed throughout the day.
|
|
실험적: Energy Restriction Comparison
Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction. Interventions: Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN) |
Diet contains all plant proteins.
Meals are evenly distributed throughout the day.
Diet contains combination of beef and plant proteins.
Meals are evenly distributed throughout the day.
Diet contains combination of beef and plant proteins.
Meals are evenly distributed throughout the day.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Daily Energy Intake: Total Daily Intake
기간: 5 months
|
Energy intake during breakfast, lunch, dinner, and evening snacks of each day 7 testing day (separated by 3-4 weeks) will be measured.
|
5 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Perceived Fullness
기간: 5 months
|
Questionnaires assessing fullness will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks).
The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response.
The scale is 0 to 100mm.
The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm).
All measures are reported at area under the curve for 0 to 630 min.
|
5 months
|
|
Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test
기간: 5 months
|
Cognitive function will be assessed during each of the 12-hour testing days using CNS Vital Signs, a validated computerized assessment.
This system contains a core battery of tasks.
Reaction Time is the outcome of interest measured with the Stroop Test.
In the first part, the words RED, YELLOW, BLUE, & GREEN (printed in black) appear at random on the screen, & the participant presses the space bar as soon as the test subject sees the word.
In the second part, the words RED, YELLOW, BLUE, & GREEN appear on the screen, printed in color.
The participant is asked to press the space bar when the color of the word matches what the word says.
In the third part, the words RED, YELLOW, BLUE, & GREEN appear on the screen, printed in color.
The participant is asked to press the space bar when the color of the word does not match what the word says.
Reaction time is in milliseconds.
|
5 months
|
|
Perceived Alertness
기간: 5 months
|
Alertness will be assessed during each of the 12-hour testing days (which are separated by 3-4 weeks) using the Profile of Mood States 2nd Edition (POMS2) with sub-categories of perceived vigor.
POM2 is a self-report measure that allows for the quick assessment of transient, fluctuating feelings, and enduring affect states.
There are 35 items.
Items are rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).
The Alertness (Vigor-Activity) scale score indicates the extent to which individual felt alert (vigorous and/or energetic); the higher are her positive feelings and/or energy, the greater is her score (i.e., a low score indicates relatively fewer positive feelings and/or low energy).
Ratings on this scale yielded a T-score of 25 (95% CI =18-32), which is ranked at the 1st percentile, and falls within the Very Low score range.
The T scores were then used to calculate area under the curve.
|
5 months
|
|
Perceived Hunger
기간: 5 months
|
Questionnaires assessing hunger will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks).
The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response.
The scale is 0 to 100mm.
The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm).
All measures are reported at area under the curve for 0 to 630 min.
|
5 months
|
|
Perceived Prospective Food Consumption
기간: 5 months
|
Questionnaires assessing prospective food consumption will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks).
The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response.
The scale is 0 to 100mm.
The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm).
All measures are reported at area under the curve for 0 to 630 min.
|
5 months
|
|
Perceived Desire to Eat
기간: 5 months
|
Questionnaires assessing desire to eat will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks).
The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response.
The scale is 0 to 100mm.
The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm).
All measures are reported at area under the curve for 0 to 630 min.
|
5 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
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- Leidy HJ, Clifton PM, Astrup A, Wycherley TP, Westerterp-Plantenga MS, Luscombe-Marsh ND, Woods SC, Mattes RD. The role of protein in weight loss and maintenance. Am J Clin Nutr. 2015 Jun;101(6):1320S-1329S. doi: 10.3945/ajcn.114.084038. Epub 2015 Apr 29.
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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
2014년 1월 1일
기본 완료 (실제)
2015년 5월 1일
연구 완료 (실제)
2015년 5월 1일
연구 등록 날짜
최초 제출
2015년 11월 23일
QC 기준을 충족하는 최초 제출
2015년 11월 23일
처음 게시됨 (추정)
2015년 11월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 7월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 4월 30일
마지막으로 확인됨
2019년 4월 1일
추가 정보
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