Acute Effects of DC7-2, a Meat Derived Octapeptide, on Appetite (SLIM8)

October 18, 2018 updated by: Arne Astrup

SLIM8 - Acute Effects of DC7-2 on Appetite

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 1958
        • Department of Human Nutrition, Faculty of Science, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: DC7-2 alone
Administration of DC7-2, a meat-derived octapeptide.
Dietary supplement: DC7-2
Effects on appetite
ACTIVE_COMPARATOR: DC7-2 + potato protein isolate
Administration of DC7-2, a meat-derived octapeptide, combined with potato protein isolate that protects DC7-2 from degradation in the GI tract.
Dietary supplement: DC7-2 + potato protein isolate
Effects on appetite
ACTIVE_COMPARATOR: Potato protein isolate + placebo
Administration of potato protein isolate combined with inactive whey protein as placebo.
Dietary supplement: Potato protein isolate
Effects on appetite
PLACEBO_COMPARATOR: Placebo
administration of inactive whey protein
Dietary supplement: Placebo
Inactive whey protein, not expected to affect appetite.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Energy intake
Time Frame: 360 min
Assessment of ad libitum energy intake when exposed to one of the test products
360 min

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective appetite sensations
Time Frame: Six hours during each test day between test day 1, 2, 3, and 4 (acute effect)
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)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Palatability of meals
Time Frame: Directly after consumption of the three meals at all four test days
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
Time Frame: Six hours during each test day between test day 1, 2, 3, and 4 (acute effect)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arne Astrup

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arne Astrup, Professor, MD DMSc, Department of Nutrition, Exercise and Sports, Research Centre Opus, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

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