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| Name | Class |
|---|---|
| Biocare Copenhagen A/S | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Encapsulated nutients | Active Comparator | 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). The encapsulated nutrients will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively. |
|
| Non-encapsulated nutrients | Sham Comparator | Nutrients known to be able to stimulate GLP-1 and PYY release if they are encapsulated to provide release at pH ≈7.0 (in the distal part of the ileum). The same capsules in a non-coated form will be provided in order to study the effect of the coating. The non-encapsulated nutrients will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively. |
|
| Placebo | Placebo Comparator | 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). The placebo capsules will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encapsulated nutrients | Dietary Supplement | Amino acid + Lipid; Probiotic bacteria |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced energy intake | Assessments of total ad libitum test meal energy intake when exposed to one or more of the encapsulated nutrients compared to the non-encapsulated nutrients and placebo | up to day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective appetite sensations | Evaluations of each of the subjective appetite sensations assessed by visual analogue scale (VAS) (satiety, fullness, hunger, prospective food consumption, desire to eat) | Three hours during each test day between test day 1, 2, 3 and 4 (acute effect) |
| Subjective appetite sensations in relation to energy consumed |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective nausea assessments | VAS assessments for nausea throughout the study test day | Three hours during each test day between test day 1, 2, 3 and 4 (acute effect) |
| Subjective nausea assessments | End of day questionnaire assessing feeling of nausea after leaving the study facility |
Inclusion Criteria:
Exclusion Criteria:
Selfreporting
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| Name | Affiliation | Role |
|---|---|---|
| Anders Sjödin, MD, PhD | University of Copenhagen, Department of Nutrition, Exercise and Sports | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, Exercise and Sports | Copenhagen | Frederiksberg | 1958 | Denmark |
No IPD will be shared
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A double-blind, randomized crossover design with four arms including three experimental conditions and placebo
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Double-blind
| Non-encapsulated nutrients |
| Dietary Supplement |
Amino acid + Lipid; Probiotic bacteria |
|
| Placebo | Dietary Supplement | Nutrient not expected to stimulate release of GLP-1 and PYY |
|
Assessing the satiety quotient (SQ) |
| up to day 4 |
| up to day 4 |