Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability
26 octobre 2020 mis à jour par: Amanda Wright, Ph.D., University of Guelph
Impact of Emulsion Droplet Physical Properties on Postprandial Lipemia and Satiety in Healthy Adult Males
The purpose of this study is to compare the changes in blood lipids and feelings of satiety after consumption of acid stable or acid unstable oil-in-water emulsions in which the droplets are in either the liquid or partially solid (i.e.
crystalline) states.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
A double blinded randomized cross-over acute meal study will be carried out in which 15 healthy male participants will attend four study visits, separated by at least one week.
On each study visit, fasted participants will consume either the emulsion with solid or liquid droplets and that is either acid stable or acid unstable, in a randomized order.
All emulsions will have similar compositions, mainly differing in terms of droplet physical state, achieved by using lipids with different melting temperature.
The emulsions will also contrast in terms of colloidal stability to acids, achieved by using different emulsifiers.
This will isolate the impacts of physical state and acid stability, and their interactions.
Postprandial lipemia, gastric emptying and satiety will be measured for 6 hours after consumption of each test beverage.
The study meals will include crushed acetaminophen, the appearance of which will be measured in plasma as a measure of liquid content gastric emptying.
It will also include periodic measurements of the gastric antrum area by ultrasound to assess the rate of gastric emptying.
Participants will be asked to maintain their usual lifestyle habits throughout the study, with some changes in the 48 hour period leading up to each of the four visits.
Type d'étude
Interventionnel
Inscription (Réel)
15
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
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 2W1
- University of Guelph
-
-
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 55 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- BMI of 18 - 26 kg/m2
- generally healthy
- non-smoking
- non to moderate alcohol drinkers
- fasting plasma cholesterol level <5.2 mmol/L
- plasma triacylglycerol level <1.7 mmol/L
- plasma glucose level <5.6 mmol/L
- no history of gastric surgeries
Exclusion Criteria:
- History of major medical conditions
- taking prescription medications/ over the counter medications
- taking natural health products/ dietary supplements (other than a multivitamin)
- oral antibiotic use in the previous 3 months
- planning to take oral antibiotics in the next 3 months
- food allergy/anaphylactic/life-threatening allergy
- smokers/ regular users of recreational drugs
- elite/ training athletes
- significant weight loss/ gain during the past 3 months
- previous reaction/ sensitivity to acetaminophen
- inability to avoid taking acetaminophen for 48 hours
- sensitivity to the artificial sweetener Sugar Twin® Sucralose and artificial vanilla extract
- not willing to consume Sugar Twin® Sucralose or Artificial vanilla.
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: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Acid stable emulsion with solid droplets
Acid stable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
|
This will be a 250 mL acid stable beverage emulsion in which the droplets are crystalline.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20% of the lipid palm stearin with 2.2% of the emulsifier sorbitan monooleate (Tween80)
|
|
Expérimental: Acid stable emulsion with liquid droplets
Acid stable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
|
This will be a 250 mL acid stable beverage emulsion in which the droplets are liquid.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20 % of the lipid palm olein with 2.2% of the emulsifier sorbitan monooleate (Tween80)
|
|
Expérimental: Acid unstable emulsion with solid droplets
Acid unstable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
|
This will be a 250 mL acid unstable beverage emulsion in which the droplets are solid.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20% of the lipid palm stearin with 2.5% of the emulsifier sorbitan monostearate (Span60)
|
|
Expérimental: Acid unstable emulsion with liquid droplets
Acid unstable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
|
This will be a 250 mL acid unstable beverage emulsion in which the droplets are liquid.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20 % of the lipid palm olein with 2.5% of the emulsifier sorbitan monostearate (Span60)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in triacylglycerol blood concentrations
Délai: 6 hours
|
Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L)
|
6 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Participant visual analogue scale ratings of feelings of satiety
Délai: 6 hours
|
Visual analogue scale ratings of feelings of hunger, fullness, appetite, prospective food consumption, desire to eat, and nausea after consuming the emulsion beverage.
0: not hungry, empty, no appetite, very little food, no desire to eat and no nausea, and 10: very hungry, very full, high appetite, a lot of food, very strong desire to eat and very nauseated.
The distance from the left end of the scale will be measured (cm)
|
6 hours
|
|
Rate of gastric emptying by measuring the changes in acetaminophen blood concentrations
Délai: 6 hours
|
The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined (mg/L)
|
6 hours
|
|
Changes in fatty acid concentration of blood triacylglycerols
Délai: 6 hour
|
Analysis based on fasting and postprandial blood sample analysis (mmol/L)
|
6 hour
|
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Changes in satiety hormone blood concentrations
Délai: 6 hours
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Analysis of blood for Ghrelin, Leptin, GLP-1,PYY, GIP, and Insulin, at fasting and postprandially (pg/mL)
|
6 hours
|
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Changes in concentrations of inflammatory blood markers (ug/mL)
Délai: 6 hours
|
Analysis of blood for CD14 and LBP at fasting and postprandially
|
6 hours
|
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Rate of gastric emptying by measuring the change in the gastric antrum area
Délai: 6 hours
|
Determined by measuring the cross-sectional area of the gastric antrum using ultrasound (cm*cm)
|
6 hours
|
|
Changes in glucose blood concentrations
Délai: 6 hour
|
Based on determination of fasting and postprandial blood glucose (mg/dL)
|
6 hour
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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
- Hamad S, Tari NR, Mathiyalagan G, Wright AJ. Emulsion acid colloidal stability and droplet crystallinity modulate postprandial gastric emptying and short-term satiety: a randomized, double-blinded, crossover, controlled trial in healthy adult males. Am J Clin Nutr. 2021 Sep 1;114(3):997-1011. doi: 10.1093/ajcn/nqab116.
- Hamad S, Thilakarathna SH, Cuncins A, Brown M, Wright AJ. Emulsion Droplet Crystallinity Attenuates Short-Term Satiety in Healthy Adult Males: A Randomized, Double-Blinded, Crossover, Acute Meal Study. J Nutr. 2020 Sep 1;150(9):2295-2304. doi: 10.1093/jn/nxaa164.
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)
12 juin 2019
Achèvement primaire (Réel)
1 mars 2020
Achèvement de l'étude (Réel)
31 août 2020
Dates d'inscription aux études
Première soumission
12 juin 2019
Première soumission répondant aux critères de contrôle qualité
17 juin 2019
Première publication (Réel)
18 juin 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 octobre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 octobre 2020
Dernière vérification
1 octobre 2020
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 19-04-003
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 .
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