Appetite; Lack or Loss, Nonorganic OriginSLIM8NCT03089190
Acute Effects of DC7-2, a Meat Derived Octapeptide, on Appetite
A study testing DC7-2, DC7-2 + potato protein isolate and Potato protein isolate in people with Appetite; Lack or Loss, Nonorganic Origin, run by Arne Astrup at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite; Lack or Loss, Nonorganic Origin
- What is being tested?
- DC7-2, DC7-2 + potato protein isolate and Potato protein isolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Aug 2017to 7 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men
- Age between 18 and 65 years
- BMI between 27-35 kg/m2
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department Of Human Nutrition, Faculty of Science, University of Copenhagen
Frederiksberg, 1958
About this study
Official title: 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.
Read the 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.
- Being tested
- DC7-2, DC7-2 + potato protein isolate, Potato protein isolate, Placebo
- Keywords
- Appetite, Satiety, Energy intake, Hunger, Peptide, Encapsulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC7-2Dietary supplement
Effects on appetite
DC7-2 + potato protein isolateDietary supplement
Effects on appetite
Potato protein isolateDietary supplement
Effects on appetite
PlaceboDietary supplement
Inactive whey protein, not expected to affect appetite.
| Study group | Role | What they receive |
|---|---|---|
| DC7-2 alone | Active comparator | Administration of DC7-2, a meat-derived octapeptide. Receives: Dietary Supplement: DC7-2 |
| 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. Receives: Dietary Supplement: DC7-2 + potato protein isolate |
| Potato protein isolate + placebo | Active comparator | Administration of potato protein isolate combined with inactive whey protein as placebo. Receives: Dietary Supplement: Potato protein isolate |
| Placebo | Placebo comparator | administration of inactive whey protein Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Assessment of ad libitum energy intake when exposed to one of the test products
Measured: 360 min
Secondary outcomes (1)
Subjective appetite sensations
Evaluations of each of the subjective appetite sensations assessed by visual analogue scale (VAS) (satiety, fullness, hunger, prospective food consumption, thirst)
Measured: Six hours during each test day between test day 1, 2, 3, and 4 (acute effect)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start21 Aug 2017
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite; Lack or Loss, Nonorganic OriginStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A double-blind, randomized crossover design with four arms including three experimental conditions and placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arne Astrup
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, Professor, MD DMSc, Principal investigator, Department of Nutrition, Exercise and Sports, Research Centre Opus, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089190
- Sponsor's protocol ID
- B330
- Acronym
- SLIM8
- Status last verified
- Oct 2018
- First submitted
- 17 Mar 2017
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLIM8 - Acute Effects of DC7-2 on Appetite
- ClinicalTrials.gov ID
- NCT03089190
- Acronym / sponsor ID
- SLIM8 / B330
- Keywords
- Appetite, Satiety, Energy intake, Hunger, Peptide, Encapsulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Arne AstrupUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A double-blind, randomized crossover design with four arms including three experimental conditions and placebo
| Arm | Type | Receives |
|---|---|---|
| DC7-2 alone | Active comparator | Dietary Supplement: DC7-2Administration of DC7-2, a meat-derived octapeptide. |
| DC7-2 + potato protein isolate | Active comparator | Dietary Supplement: DC7-2 + potato protein isolateAdministration 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 | Dietary Supplement: Potato protein isolateAdministration of potato protein isolate combined with inactive whey protein as placebo. |
| Placebo | Placebo comparator | Dietary Supplement: Placeboadministration of inactive whey protein |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men
- Age between 18 and 65 years
- BMI between 27-35 kg/m2
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC7-2Effects on appetite | Dietary supplement | DC7-2 alone |
| DC7-2 + potato protein isolateEffects on appetite | Dietary supplement | DC7-2 + potato protein isolate |
| Potato protein isolateEffects on appetite | Dietary supplement | Potato protein isolate + placebo |
| PlaceboInactive whey protein, not expected to affect appetite. | Dietary supplement | Placebo |
Primary outcome
Energy intake
Time frame: 360 min
Assessment of ad libitum energy intake when exposed to one of the test products
1 secondary outcome
Subjective appetite sensations
Time frame: Six hours during each test day between test day 1, 2, 3, and 4 (acute effect)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Individual participant dataSharing planned: No. No IPD will be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Professor, MD DMSc principal investigator
Department of Nutrition, Exercise and Sports, Research Centre Opus, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DC7-2, DC7-2 + potato protein isolate and Potato protein isolate in people with Appetite; Lack or Loss, Nonorganic Origin, run by Arne Astrup at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake (time frame: 360 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.