Encapsulated Nutrients' Acute Effects on Appetite; ENcapsulated, lipiD, aminO, pRobiotic, SatiEty (ENDORSE)
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|ClinicalTrials.gov Identifier: NCT03080909|
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Appetite; Lack or Loss, Nonorganic Origin||Dietary Supplement: Encapsulated nutrients Dietary Supplement: Placebo||Not Applicable|
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 6)), 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, use of concomitant medications and consumption of fermented milk products. 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 a standardized fixed breakfast (providing 2000 kJ) and 60 minutes prior to a standardized fixed mid-morning snack (providing 1500 kJ). An ad libitum test meal will be provided 6 hour after first provision of capsules (time 0). There will be 2 hour interval between the two servings of capsules and 4 hour interval between the second serving of capsules and the ad libitum test meal.
Immediately before and after each episode of capsules and food consumption and at 30 minutes intervals, VAS' will be completed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||A double-blind, randomized crossover design with five arms including four experimental conditions and placebo|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Encapsulated Nutrients' Acute Effects on Appetite|
|Actual Study Start Date :||March 28, 2017|
|Actual Primary Completion Date :||June 8, 2017|
|Actual Study Completion Date :||June 8, 2017|
Active Comparator: Encapsulated nutients
Encapsulated nutrients known to be able to stimulate GLP-1 and PYY release. Encapsulated with coating providing release at pH≈7.0 (in the distal part of the ileum) expected to start approximately 3 hour following ingestion.
The encapsulated nutrients will be provided 30 minutes prior to the standardized fixed breakfast (providing 2000 kJ) and 60 minutes prior to the standardized fixed mid-morning snack (providing 1500 kJ), i.e. test products will be provided 6 hour and 4 hour before the ad libitum test meal, respectively.
Dietary Supplement: Encapsulated nutrients
Amino acid + Lipid; Probiotic bacteria; Lipid; Amino acid selected on their ability to stimulate release of GLP-1 and PYY
Placebo Comparator: Placebo
Nutrients known to have limited stimulation on GLP-1 and PYY release. Encapsulated with coating providing release at pH≈7.0 (in the distal part of the ileum) expected to start approximately 3 hour following ingestion.
The placebo products will be provided 30 minutes prior to the standardized fixed breakfast (providing 2000 kJ) and 60 minutes prior to the standardized fixed mid-morning snack (providing 1500 kJ), i.e. placebo products will be provided 6 hour and 4 hour before the ad libitum test meal, respectively.
Dietary Supplement: Placebo
Maltodextrin, which is not expected to stimulate release of GLP-1 and PYY
- Reduced energy intake [ Time Frame: up to day 5 ]Assessments of ad libitum test meal when exposed to one or more of the encapsulated nutrients compared to the placebo
- Subjective appetite sensations [ Time Frame: Six hours during each test day between test day 1, 2, 3, 4 and 5 (acute effect) ]Evaluations of each of the subjective appetite sensations assessed by visual analogue scale (VAS) (satiety, fullness, hunger, prospective food consumption, desire to eat)
- Subjective appetite sensations in relation to energy consumed [ Time Frame: up to day 5 ]Assessing the appetite quotient (AQ)
- Subjective nausea assessments [ Time Frame: Six hours during each test day between test day 1, 2, 3, 4 and 5 (acute effect) ]VAS assessments for nausea throughout the study test day
- Subjective nausea assessments [ Time Frame: up to day 5 ]End of day questionnaire assessing feeling of nausea after leaving the study facility
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080909
|Department of Nutrition, Exercise and Sports|
|Copenhagen, Frederiksberg, Denmark, 1958|
|Principal Investigator:||Anders Sjödin, MD, PhD||Department of Nutrition, Exercise and Sports|