High Quality Protein for Assisting With Weight Loss (Egg_breakfast)
28 mai 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Texas
-
Lubbock, Texas, États-Unis, 79409
- Texas Tech University - Department of Nutritional Sciences
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 44 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
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.
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.
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
|
|
Comparateur actif: 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. |
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.
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change of subjective satiety
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in body weight (kg)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: Day 0
|
Difference of measurements between self report survey and objective results
|
Day 0
|
|
Self report of desire to lose weight and ideal weight
Délai: Day 0
|
Day 0
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Nikhil Dhurandhar, Chair of the Nutritional Sciences Department
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Vander Wal JS, Marth JM, Khosla P, Jen KL, Dhurandhar NV. Short-term effect of eggs on satiety in overweight and obese subjects. J Am Coll Nutr. 2005 Dec;24(6):510-5. doi: 10.1080/07315724.2005.10719497.
- Vander Wal JS, Gupta A, Khosla P, Dhurandhar NV. Egg breakfast enhances weight loss. Int J Obes (Lond). 2008 Oct;32(10):1545-51. doi: 10.1038/ijo.2008.130. Epub 2008 Aug 5.
- Bayham BE, Greenway FL, Johnson WD, Dhurandhar NV. A randomized trial to manipulate the quality instead of quantity of dietary proteins to influence the markers of satiety. J Diabetes Complications. 2014 Jul-Aug;28(4):547-52. doi: 10.1016/j.jdiacomp.2014.02.002. Epub 2014 Feb 13.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 août 2017
Achèvement primaire (Réel)
17 mai 2019
Achèvement de l'étude (Réel)
17 mai 2019
Dates d'inscription aux études
Première soumission
15 mars 2017
Première soumission répondant aux critères de contrôle qualité
15 mars 2017
Première publication (Réel)
21 mars 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 mai 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 mai 2019
Dernière vérification
1 mai 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TTU IRB2016-1137
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .