The Consumption of Beef on Appetite and Cognitive Function
tiistai 30. huhtikuuta 2019 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
35
Vaihe
- Ei sovellettavissa
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 52 vuotta (Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Nainen
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Daily Energy Intake: Total Daily Intake
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Perceived Fullness
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
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- Weigle DS, Breen PA, Matthys CC, Callahan HS, Meeuws KE, Burden VR, Purnell JQ. A high-protein diet induces sustained reductions in appetite, ad libitum caloric intake, and body weight despite compensatory changes in diurnal plasma leptin and ghrelin concentrations. Am J Clin Nutr. 2005 Jul;82(1):41-8. doi: 10.1093/ajcn.82.1.41.
- 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.
- Paddon-Jones D, Leidy H. Dietary protein and muscle in older persons. Curr Opin Clin Nutr Metab Care. 2014 Jan;17(1):5-11. doi: 10.1097/MCO.0000000000000011.
- Leidy HJ, Carnell NS, Mattes RD, Campbell WW. Higher protein intake preserves lean mass and satiety with weight loss in pre-obese and obese women. Obesity (Silver Spring). 2007 Feb;15(2):421-9. doi: 10.1038/oby.2007.531.
- Gualtieri CT, Johnson LG. Reliability and validity of a computerized neurocognitive test battery, CNS Vital Signs. Arch Clin Neuropsychol. 2006 Oct;21(7):623-43. doi: 10.1016/j.acn.2006.05.007. Epub 2006 Oct 2.
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- Johnston CS, Tjonn SL, Swan PD. High-protein, low-fat diets are effective for weight loss and favorably alter biomarkers in healthy adults. J Nutr. 2004 Mar;134(3):586-91. doi: 10.1093/jn/134.3.586.
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- Leidy HJ, Bossingham MJ, Mattes RD, Campbell WW. Increased dietary protein consumed at breakfast leads to an initial and sustained feeling of fullness during energy restriction compared to other meal times. Br J Nutr. 2009 Mar;101(6):798-803. doi: 10.1017/s0007114508051532.
- Hoyland A, Dye L, Lawton CL. A systematic review of the effect of breakfast on the cognitive performance of children and adolescents. Nutr Res Rev. 2009 Dec;22(2):220-43. doi: 10.1017/S0954422409990175.
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- Leidy HJ, Todd CB, Zino AZ, Immel JE, Mukherjea R, Shafer RS, Ortinau LC, Braun M. Consuming High-Protein Soy Snacks Affects Appetite Control, Satiety, and Diet Quality in Young People and Influences Select Aspects of Mood and Cognition. J Nutr. 2015 Jul;145(7):1614-22. doi: 10.3945/jn.115.212092. Epub 2015 May 20.
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- Gwin JA, Maki KC, Alwattar AY, Leidy HJ. Examination of Protein Quantity and Protein Distribution across the Day on Ad Libitum Carbohydrate and Fat Intake in Overweight Women. Curr Dev Nutr. 2017 Oct 25;1(12):e001933. doi: 10.3945/cdn.117.001933. eCollection 2017 Dec.
- Gwin JA, Maki KC, Leidy HJ. Increased Protein Consumption during the Day from an Energy-Restricted Diet Augments Satiety but Does Not Reduce Daily Fat or Carbohydrate Intake on a Free-Living Test Day in Overweight Women. J Nutr. 2017 Dec;147(12):2338-2346. doi: 10.3945/jn.117.255554. Epub 2017 Oct 25.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Keskiviikko 1. tammikuuta 2014
Ensisijainen valmistuminen (Todellinen)
Perjantai 1. toukokuuta 2015
Opintojen valmistuminen (Todellinen)
Perjantai 1. toukokuuta 2015
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 23. marraskuuta 2015
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 23. marraskuuta 2015
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 25. marraskuuta 2015
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 8. heinäkuuta 2019
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 30. huhtikuuta 2019
Viimeksi vahvistettu
Maanantai 1. huhtikuuta 2019
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 0039674
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
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