Acute Effects of DC7-2, a Meat Derived Octapeptide, on Appetite (SLIM8)
Primary Purpose
Appetite; Lack or Loss, Nonorganic Origin
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
DC7-2
DC7-2 + potato protein isolate
Potato protein isolate
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Appetite; Lack or Loss, Nonorganic Origin focused on measuring Appetite, Satiety, Energy intake, Hunger, Peptide, Encapsulation
Eligibility Criteria
Inclusion Criteria:
- Healthy men
- Age between 18 and 65 years
- BMI between 27-35 kg/m2
Exclusion Criteria:
- Vegetarians
- Participants unable to consume or known to get nausea from consuming 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
- Weight change of ±3 kg two months prior to the study
- Vigorous physical activity more than 5 hours/week
- Alcohol intake above the recommendations from the Danish Health and Medicines Authority (>14 units/week)
- Substance abuse
- Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes, gum etc.). Irregular smokers accepted
- Use currently or within the previous 3 months of any medication or supplements known to affect appetite or body weight as judged by the investigators
- Chronic diseases (e.g. cancer, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders) or other relevant health problems as judged by the investigators
- Simultaneous or within the past month participation in other clinical studies
- Participant's general condition contraindicates participating in the study, as judged by the investigators or the medical expert
Sites / Locations
- Department Of Human Nutrition, Faculty of Science, University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
DC7-2 alone
DC7-2 + potato protein isolate
Potato protein isolate + placebo
Placebo
Arm Description
Administration of DC7-2, a meat-derived octapeptide.
Administration of DC7-2, a meat-derived octapeptide, combined with potato protein isolate that protects DC7-2 from degradation in the GI tract.
Administration of potato protein isolate combined with inactive whey protein as placebo.
administration of inactive whey protein
Outcomes
Primary Outcome Measures
Energy intake
Assessment of ad libitum energy intake when exposed to one of the test products
Secondary Outcome Measures
Subjective appetite sensations
Evaluations of each of the subjective appetite sensations assessed by visual analogue scale (VAS) (satiety, fullness, hunger, prospective food consumption, thirst)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03089190
Brief Title
Acute Effects of DC7-2, a Meat Derived Octapeptide, on Appetite
Acronym
SLIM8
Official Title
SLIM8 - Acute Effects of DC7-2 on Appetite
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
December 7, 2017 (Actual)
Study Completion Date
December 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arne Astrup
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite; Lack or Loss, Nonorganic Origin
Keywords
Appetite, Satiety, Energy intake, Hunger, Peptide, Encapsulation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A double-blind, randomized crossover design with four arms including three experimental conditions and placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DC7-2 alone
Arm Type
Active Comparator
Arm Description
Administration of DC7-2, a meat-derived octapeptide.
Arm Title
DC7-2 + potato protein isolate
Arm Type
Active Comparator
Arm Description
Administration of DC7-2, a meat-derived octapeptide, combined with potato protein isolate that protects DC7-2 from degradation in the GI tract.
Arm Title
Potato protein isolate + placebo
Arm Type
Active Comparator
Arm Description
Administration of potato protein isolate combined with inactive whey protein as placebo.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
administration of inactive whey protein
Intervention Type
Dietary Supplement
Intervention Name(s)
DC7-2
Intervention Description
Effects on appetite
Intervention Type
Dietary Supplement
Intervention Name(s)
DC7-2 + potato protein isolate
Intervention Description
Effects on appetite
Intervention Type
Dietary Supplement
Intervention Name(s)
Potato protein isolate
Intervention Description
Effects on appetite
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Inactive whey protein, not expected to affect appetite.
Primary Outcome Measure Information:
Title
Energy intake
Description
Assessment of ad libitum energy intake when exposed to one of the test products
Time Frame
360 min
Secondary Outcome Measure Information:
Title
Subjective appetite sensations
Description
Evaluations of each of the subjective appetite sensations assessed by visual analogue scale (VAS) (satiety, fullness, hunger, prospective food consumption, thirst)
Time Frame
Six hours during each test day between test day 1, 2, 3, and 4 (acute effect)
Other Pre-specified Outcome Measures:
Title
Palatability of meals
Description
All three meals are rated for their palatability e.g. smell, taste and appearance
Time Frame
Directly after consumption of the three meals at all four test days
Title
Subjective assessments of nausea and general wellbeing
Description
VAS assessments for nausea and general wellbeing throughout the study test day
Time Frame
Six hours during each test day between test day 1, 2, 3, and 4 (acute effect)
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Selfreporting
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy men
Age between 18 and 65 years
BMI between 27-35 kg/m2
Exclusion Criteria:
Vegetarians
Participants unable to consume or known to get nausea from consuming 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
Weight change of ±3 kg two months prior to the study
Vigorous physical activity more than 5 hours/week
Alcohol intake above the recommendations from the Danish Health and Medicines Authority (>14 units/week)
Substance abuse
Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes, gum etc.). Irregular smokers accepted
Use currently or within the previous 3 months of any medication or supplements known to affect appetite or body weight as judged by the investigators
Chronic diseases (e.g. cancer, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders) or other relevant health problems as judged by the investigators
Simultaneous or within the past month participation in other clinical studies
Participant's general condition contraindicates participating in the study, as judged by the investigators or the medical expert
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Astrup, Professor, MD DMSc
Organizational Affiliation
Department of Nutrition, Exercise and Sports, Research Centre Opus, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department Of Human Nutrition, Faculty of Science, University of Copenhagen
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared
Learn more about this trial
Acute Effects of DC7-2, a Meat Derived Octapeptide, on Appetite
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