Last updated on February 2018

Encapsulated Nutrients' Acute Effects on Appetite; ENcapSulated nUtRiEnts (ENSURE)

Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03284554

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