Acute Effects of DC7-2, a Meat Derived Octapeptide, on Appetite
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
      are separated with at least 7 days, however 4 days can be accepted for logistical reasons.
      During the entire course of the study, participants must remain weight stable and not change
      their 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, participants will be asked avoid excessive alcohol consumption (not
      above 1 unit and no alcohol at all from 8 pm the night before the test days) and intense
      physical activity 48 hours prior to the test day. Also, they will be asked to consume a
      standardized meal at home no later than 8 pm the night before the test days. This meal is
      prepared and delivered by the department.

      Furthermore, the participants must arrive at the study facilities in the morning after an
      overnight fast (from 10 pm) using non strenuous means of transportation.

      Over the course of the study (from screening (visit 1) to completion of the last test day
      (visit 5)), 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 before initiating each test day.
      Possible in-compliance with the standardization will be judged by the sub-investigator
      whether to result in rescheduling of the visit or to be recorded as a protocol deviation.

      Participants arrive at the study facility 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 with other participants,
      but 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 prior to a standardized fixed breakfast, prior
      to a standardized fixed mid-morning snack and prior to an ad libitum meal. Immediately before
      and after each episode of capsules and food consumption and at 30 minutes intervals, VAS'
      will be completed. Energy intake will be calculated from the ad libitum meal.
    

Intervention name(s): DC7-2; DC7-2 + potato protein isolate; Potato protein isolate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Effects on appetite; Effects on appetite; Effects on appetite; Inactive whey protein, not expected to affect appetite.
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: Appetite; Satiety; Energy intake; Hunger; Peptide; Encapsulation