Digestion of Biopolymer Based Lipid Emulsions
Condition: Healthy
Study type: Interventional

Summary: 
      In this randomized, double blind, unbalanced three way crossover trial, four lipid emulsions
      will be assessed on three study days. The lipid emulsions (LEs) have been engineered so that
      they differ in terms of acid stability, lipid droplet size and fat redispersibility. The
      investigators hypothesize that the gastric emptying of fat will differ between the lipid
      emulsions.

      An optional study day (visit 5) will be used to assess the degree of lipolysis in Lipid
      emulsion 5 (LE5) and Lipid emulsion 6 (LE6). This study day is a randomized, single blinded
      study.
    

Detailed description: 
      The physical state of fat has been demonstrated to affect the rate of fat digestion. By
      engineering the physical properties of lipid emulsions the investigators are able to alter
      characteristics such as acid stability, lipid droplet size and fat redispersibility. These
      factors have been shown to modulate the physical state of fat in the stomach, the subsequent
      fat gastric emptying and digestion as well as satiation in healthy subjects. The
      investigators have recently developed a new series of lipid emulsions based on biopolymers.
      Preliminary animal studies have shown that these emulsions are able to effect GI physiology
      including GI peptide hormones and eating behavior. The primary aim of this work is to apply
      these biopolymer based lipid emulsions in healthy subjects and investigate their impact on
      fat digestion and satiation. A secondary aim is to develop an image analysis method that can
      quantify the heterogeneity of fat distribution within gastric content from the MRI data.

      The participants (n=17) will be randomized at screening to receive 3 of the 4 lipid emulsions
      (LE).

      On each of the three study days subjects will receive 200 mL of a lipid emulsion. MRI scans
      will be performed at regular intervals over a period of 3.5 h. Blood samples (for GI peptide
      hormone analysis) will also be taken at regular intervals until 5 h post LE ingestion.
      Further, 13C breath test samples will be obtained from participants every 10 min until 5 h
      post ingestion of LE. Throughout the entire 5 h study period participants will be asked to
      score their visceral sensation in relation to satiation. Once the technical section of the
      study is complete the participant will be provided with an ad libitum buffet from which they
      can consume as much or a little of the food options provided in the buffet.

      Optional study day: After the main study is complete and the MRI data has been analyzed the
      study will be unblinded. This will enable the investigators to optimize an MR imaging and
      gastric content sampling schedule for LE5 and LE6. The participants (n=17) will be randomized
      and 10 subjects will then be given the opportunity to participate in the optional study day.
      The optional study day is single blinded and consists of 1 extra visit and is of a maximum 3
      h duration. No bloods, breath test samples or visceral sensation scores will be taken.
      Subjects will arrive fasted and a nasogastric tube will be positioned. 200 mL of either LE5
      or LE6 containing the 13C breath test marker will then be infused. MR imaging will continue
      at defined intervals until maximum of 3 h. In total five gastric content samples of 5 mL will
      be taken with the nasogastric tube.
    

Intervention name(s): Lipid emulsion; Lipid emulsion; Lipid emulsion
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 2.; 1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 3.; 1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 4.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Gastric emptying; MRI; lipid emulsions; breath test; GI peptide hormones