Encapsulated Nutrients' Acute Effects on Appetite; ENcapSulated, nUtRiEnts (ENSURE)
Condition: Appetite; Lack or Loss, Nonorganic Origin
MeSH terms: Anorexia
Study type: Interventional

Summary: 
      A double-blind, randomized crossover design with four arms including three experimental
      conditions and placebo will be applied. After having successfully completed screening
      procedures, eligible participants will be invited to four separate test days. The test days
      cannot be within the same week, however there is no upper limit for days in between, as long
      as the participants remain weight stable and do not change diet or physical activity level.
      Significant changes in diet, physical activity level (evaluated by the sub-investigator) or
      weight change ±3 kg over the course of the study (from screening to completion of the last
      test day) results in exclusion of that subject.
    

Detailed description: 
      For standardization, 48 hours before the test days, the participants will be asked to consume
      a regular diet compliant to what they usually eat and no excessive alcohol consumption (not
      above 5 units and no alcohol at all from 8 pm the night before the test days) or intense
      physical activity compared to what they normally do is allowed. Additionally, the
      participants must arrive at the study facilities in the morning after an overnight fast (from
      10 pm) using non strenuous means of transportation. Furthermore, over the course of the study
      (from screening (visit 1) to completion of the last test day (visit 5)), the participants are
      not allowed to change body weight (±3 kg), diet or physical activity level (as judged by the
      sub-investigator). The participants will be weighed and asked about compliance with
      additional standardization in a room away from the other participants before initiating each
      test day. Possible in-compliance with the standardization will be judged by the
      sub-investigator whether to result in re-scheduling of the visit or to be recorded as a
      protocol deviation.

      Participants arrive at the study facility at 07:30 in the morning. Compliance with
      standardization is controlled along with registration of possible adverse events and use of
      concomitant medications. During the test days, participants are settled together in an open
      office, where they are separated at individual tables. During the meals, participants are
      settled into individual feeding cubicles, where they cannot see each other and are instructed
      not to talk to each other.

      Visual analogue scales (VAS') will be completed for measurement of fasting subjective
      appetite levels.

      The test products (capsules) will be provided 30 minutes prior to an ad libitum test
      breakfast and 3 hour prior to an ad libitum test lunch.

      Immediately before and after each episode of capsules and food consumption and at 30 minutes
      intervals, VAS' will be completed.
    

Intervention name(s): Encapsulated nutrients; Non-encapsulated nutrients; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Amino acid + Lipid; Probiotic bacteria; Amino acid + Lipid; Probiotic bacteria; Nutrient not expected to stimulate release of GLP-1 and PYY
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A double-blind, randomized crossover design with four arms including three experimental conditions and placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Satiety; Nutrients; Appetite; Encapsulation; Lipid; Amino acid; Probiotic bacteria