Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability
Condition: Healthy
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Acid stable emulsion with solid droplets; Acid stable emulsion with liquid droplets; Acid unstable emulsion with solid droplets; Acid unstable emulsion with liquid droplets
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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); 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); 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); 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)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science