Clinical trial NCT03284554: Encapsulated Nutrients' Acute Effects on Appetite; ENcapSulated, nUtRiEnts (ENSURE)
Official title: Encapsulated Nutrients' Acute Effects on Appetite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite; Lack or Loss, Nonorganic Origin
Keywords: Satiety
Nutrients
Appetite
Encapsulation
Lipid
Amino acid
Probiotic bacteria
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Biocare Copenhagen A/S
First posted: 2017-09-15
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A double-blind, randomized crossover design with four arms including three experimental conditions and placebo
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Participants who have provided written informed consent
* Healthy men
* Age between 18 and 60 years
* BMI between 18.5-32 kg/m2
* Regular breakfast eaters (eating breakfast ≥ 4 times a week)

Exclusion Criteria:

* Participants unable to consume or known to get nausea from consuming 20 medium sized capsules (placebo capsules will be provided at screening for test of ability to consume the relevant amount of capsules)
* Participants not able to comply with the study protocol, including consumption of the specific study foods (pictures of study foods shown at screening)
* Any known food allergies or food intolerance likely to affect the present study
* Significant health problems as judged by the principal investigator
* Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the study professional
* Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) \< 4 weeks before study start
* Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) during the study
* Use of systemic medical treatment likely to interfere with evaluation of the study parameters as judged by the principal investigator
* Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes, gum etc.). Irregular smokers accepted
* Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
* Significant weight changes (±3 kg) over the course of the study (from screening to completion of last test day)
* Significant changes in physical activity patterns in the past 4 weeks or significant changes over the course of the study (from screening to completion of last test day) as judged by the sub-investigator
* Significant changes in diet in the past 4 weeks or significant changes over the course of the study (from screening to completion of last test day) as judged by the sub-investigator
* Participants who work in appetite related areas
* Simultaneous or within the past month participating in other clinical trials that can interfere with the study

Primary outcomes:
measure: Reduced energy intake
timeFrame: up to day 4
Secondary outcomes:
measure: Subjective appetite sensations
timeFrame: Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)
measure: Subjective appetite sensations in relation to energy consumed
timeFrame: up to day 4
Other outcomes:
measure: Subjective nausea assessments
timeFrame: Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)
measure: Subjective nausea assessments
timeFrame: up to day 4
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
state: Frederiksberg
Study officials:
affiliation: University of Copenhagen, Department of Nutrition, Exercise and Sports
name: Anders Sjödin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: