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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC7-2 alone | Active Comparator | Administration of DC7-2, a meat-derived octapeptide. |
|
| DC7-2 + potato protein isolate | Active Comparator | Administration of DC7-2, a meat-derived octapeptide, combined with potato protein isolate that protects DC7-2 from degradation in the GI tract. |
|
| Potato protein isolate + placebo | Active Comparator | Administration of potato protein isolate combined with inactive whey protein as placebo. |
|
| Placebo | Placebo Comparator | administration of inactive whey protein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC7-2 | Dietary Supplement | Effects on appetite |
| |
| DC7-2 + potato protein isolate |
| Measure | Description | Time Frame |
|---|---|---|
| Energy intake | Assessment of ad libitum energy intake when exposed to one of the test products | 360 min |
| 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, thirst) | Six hours during each test day between test day 1, 2, 3, and 4 (acute effect) |
| Measure | Description | Time Frame |
|---|---|---|
| Palatability of meals | All three meals are rated for their palatability e.g. smell, taste and appearance | Directly after consumption of the three meals at all four test days |
| Subjective assessments of nausea and general wellbeing |
Inclusion Criteria:
Exclusion Criteria:
Selfreporting
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| Name | Affiliation | Role |
|---|---|---|
| Arne Astrup, Professor, MD DMSc | Department of Nutrition, Exercise and Sports, Research Centre Opus, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department Of Human Nutrition, Faculty of Science, University of 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
| Dietary Supplement |
Effects on appetite |
|
| Potato protein isolate | Dietary Supplement | Effects on appetite |
|
| Placebo | Dietary Supplement | Inactive whey protein, not expected to affect appetite. |
|
VAS assessments for nausea and general wellbeing throughout the study test day
| Six hours during each test day between test day 1, 2, 3, and 4 (acute effect) |