Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability
26 ottobre 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
15
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 2W1
- University of Guelph
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 55 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Maschio
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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)
|
|
Sperimentale: 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)
|
|
Sperimentale: 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)
|
|
Sperimentale: 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)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes in triacylglycerol blood concentrations
Lasso di tempo: 6 hours
|
Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L)
|
6 hours
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Participant visual analogue scale ratings of feelings of satiety
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 hour
|
Analysis based on fasting and postprandial blood sample analysis (mmol/L)
|
6 hour
|
|
Changes in satiety hormone blood concentrations
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 6 hours
|
Determined by measuring the cross-sectional area of the gastric antrum using ultrasound (cm*cm)
|
6 hours
|
|
Changes in glucose blood concentrations
Lasso di tempo: 6 hour
|
Based on determination of fasting and postprandial blood glucose (mg/dL)
|
6 hour
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
12 giugno 2019
Completamento primario (Effettivo)
1 marzo 2020
Completamento dello studio (Effettivo)
31 agosto 2020
Date di iscrizione allo studio
Primo inviato
12 giugno 2019
Primo inviato che soddisfa i criteri di controllo qualità
17 giugno 2019
Primo Inserito (Effettivo)
18 giugno 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 ottobre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 ottobre 2020
Ultimo verificato
1 ottobre 2020
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 19-04-003
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .