Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability
26. Oktober 2020 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
15
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Ontario
-
Guelph, Ontario, Kanada, N1G 2W1
- University of Guelph
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Männlich
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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)
|
|
Experimental: 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)
|
|
Experimental: 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)
|
|
Experimental: 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)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Changes in triacylglycerol blood concentrations
Zeitfenster: 6 hours
|
Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L)
|
6 hours
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Participant visual analogue scale ratings of feelings of satiety
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 hour
|
Analysis based on fasting and postprandial blood sample analysis (mmol/L)
|
6 hour
|
|
Changes in satiety hormone blood concentrations
Zeitfenster: 6 hours
|
Analysis of blood for Ghrelin, Leptin, GLP-1,PYY, GIP, and Insulin, at fasting and postprandially (pg/mL)
|
6 hours
|
|
Changes in concentrations of inflammatory blood markers (ug/mL)
Zeitfenster: 6 hours
|
Analysis of blood for CD14 and LBP at fasting and postprandially
|
6 hours
|
|
Rate of gastric emptying by measuring the change in the gastric antrum area
Zeitfenster: 6 hours
|
Determined by measuring the cross-sectional area of the gastric antrum using ultrasound (cm*cm)
|
6 hours
|
|
Changes in glucose blood concentrations
Zeitfenster: 6 hour
|
Based on determination of fasting and postprandial blood glucose (mg/dL)
|
6 hour
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
12. Juni 2019
Primärer Abschluss (Tatsächlich)
1. März 2020
Studienabschluss (Tatsächlich)
31. August 2020
Studienanmeldedaten
Zuerst eingereicht
12. Juni 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. Juni 2019
Zuerst gepostet (Tatsächlich)
18. Juni 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. Oktober 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Oktober 2020
Zuletzt verifiziert
1. Oktober 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 19-04-003
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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