Development of Melt Organic Baking Fat for Reducing Child Obesity
Development and Expansion of Melt Organic Baking Fat for Oxidative Stability and Reducing Child Obesity
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The overall objectives of this study are to determine whether a Melt Organic baking blend can alter energy balance towards a negative energy balance by enhancing thermic effect of food and improving feelings of satiety relative to a control, corn oil, in overweight and obese adolescents.
This study will employ a 2-arm, double-blind, randomized, crossover design. Each arm will consist of one test day and will differ in the type of oil incorporated in the test breakfast: test blend 3.2 or corn oil. Oil sequence will be randomized. Each test day will follow the same protocol and will be separated by at least two weeks for boys or 4 weeks for girls to ensure that testing occurs during the same phase of their menstrual cycle for each test day.
Participants will arrive at the testing center after an overnight 12-h fast. Upon arrival, body weight will be taken and a catheter will be inserted in an antecubital vein. The participant will then rest for 30 minutes, after which resting metabolic rate (RMR) will be measured using an indirect calorimetry cart. RMR will be measured over a 45-min period. At the end of the RMR measurement, a fasting blood sample will be obtained, and the participant will be given a standard breakfast (containing 20 g of fat from either test blend 3.2 or corn oil) to consume over a 10-min period. The fat in the breakfast will be provided in test muffins. The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation. The muffin will provide 450 kcal and the rest of the energy will be provided in the form of fat free yogurt, up to 140 kcal, and applesauce.
Following breakfast, postprandial energy expenditure will be assessed every hour using the indirect calorimetry cart. At each hour of this 5-h period, participants will fill out a visual analog scale to assess their feelings of appetite and satiety and will perform a computer task assessing prospective food intake. Immediately after breakfast, and at 30, 45, 60, 120, and 180 minutes after breakfast, a blood sample will be drawn from the catheter for metabolite and hormone measurements.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10032
- New York Nutrition Obesity Research Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Body Mass Index (BMI) equal to or greater than 85th percentile for age and sex
- Weight stable (+/- 2.5 kg) for at least 3 months prior to screening
Exclusion Criteria:
- Any endocrine disorder, including type 1 diabetes
- Weight loss attempted in past 3 months
- Currently using medication (prescription or over-the-counter) that could impact study outcomes
- Asthma
- Anemia
- Diagnosis of psychoses, bipolar disorder, major depression, severe personality disorder; history of suicidal tendencies
- Use of (current or in the past 4 weeks) any investigational medications or devices
- Allergy/sensitivity to wheat, milk, eggs, nuts
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Melt test blend 3.2
|
Participant will be given a standard breakfast (containing 20 g of fat from test blend 3.2) to consume over a 10-min period.
Test blend 3.2 will be provided in test muffins.
The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation.
The muffin will provide 450 kcal, and the rest of the energy will be in the form of fat free yogurt, up to 140 kcal, and applesauce.
|
|
Comparateur actif: Corn Oil
|
Participant will be given a standard breakfast (containing 20 g of fat from corn oil) to consume over a 10-min period.
Corn oil will be provided in test muffins.
The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation.
The muffin will provide 450 kcal, and the rest of the energy will be in the form of fat free yogurt, up to 140 kcal, and applesauce.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Thermic effect of food
Délai: 5.5 hours
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An indirect calorimetry cart will measure energy expenditure for approximately 40 minutes out of each hour for 5 hours after breakfast.
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5.5 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Appetite/satiety measures area under the curve
Délai: 5.5 hours
|
A visual analog scale and a computer program will assess different aspects of appetite and satiety in study participants.
|
5.5 hours
|
|
Insulin, glucose, triglycerides area under the curve
Délai: Fasting, and at minutes 0, 30, 45, 60, 120, and 180 after the end of breakfast
|
Blood draw and analyses will be used to measure triglycerides, glucose, and insulin.
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Fasting, and at minutes 0, 30, 45, 60, 120, and 180 after the end of breakfast
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Marie-Pierre St-Onge, Ph.D., Columbia University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AAAN3253
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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