Appetite; Lack or Loss, Nonorganic OriginENSURENCT03284554
Encapsulated Nutrients' Acute Effects on Appetite; ENcapSulated, nUtRiEnts (ENSURE)
A study testing Encapsulated nutrients and Non-encapsulated nutrients 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 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite; Lack or Loss, Nonorganic Origin
- What is being tested?
- Encapsulated nutrients and Non-encapsulated nutrients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Nov 2017to 15 Feb 2018
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who have provided written informed consent
- Healthy men
- Age between 18 and 60 years
- BMI between 18.5-32 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
Who cannot join
- Participants unable to consume or known to get nausea from consuming 20 medium sized capsules (placebo capsules will be provided at screening for test of ability to consume the relevant amount of 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
- Significant health problems as judged by the principal investigator
- Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the study professional
- Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) < 4 weeks before study start
Show all 15Show fewer
- Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) during the study
- Use of systemic medical treatment likely to interfere with evaluation of the study parameters as judged by the principal investigator
- Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes, gum etc.). Irregular smokers accepted
- Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
- Significant weight changes (±3 kg) over the course of the study (from screening to completion of last test day)
- Significant changes in physical activity patterns in the past 4 weeks or significant changes over the course of the study (from screening to completion of last test day) as judged by the sub-investigator
- Significant changes in diet in the past 4 weeks or significant changes over the course of the study (from screening to completion of last test day) as judged by the sub-investigator
- Participants who work in appetite related areas
- Simultaneous or within the past month participating in other clinical trials that can interfere with the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, 1958
About this study
Official title: Encapsulated Nutrients' Acute Effects 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 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.
Read the detailed description
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.
- Being tested
- Encapsulated nutrients, Non-encapsulated nutrients, Placebo
- Keywords
- Satiety, Nutrients, Appetite, Encapsulation, Lipid, Amino acid, Probiotic bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encapsulated nutrientsDietary supplement
Amino acid + Lipid; Probiotic bacteria
Non-encapsulated nutrientsDietary supplement
Amino acid + Lipid; Probiotic bacteria
PlaceboDietary supplement
Nutrient not expected to stimulate release of GLP-1 and PYY
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Encapsulated nutrients |
| 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. Receives: Dietary Supplement: Non-encapsulated nutrients |
| 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to day 4
Secondary outcomes (2)
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)
Measured: Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)
Subjective appetite sensations in relation to energy consumed
Assessing the satiety quotient (SQ)
Measured: up to day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start13 Nov 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arne Astrup
- Sponsor type
- University, hospital or other
- Collaborators
- Biocare Copenhagen A/S
- Responsible party
- Sponsor-investigator, Arne Astrup, University of Copenhagen
- Investigators
- Anders Sjödin, MD, PhD, Principal investigator, University of Copenhagen, Department of Nutrition, Exercise and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284554
- Sponsor's protocol ID
- B342
- Acronym
- ENSURE
- Status last verified
- Feb 2018
- First submitted
- 13 Sep 2017
- Last updated
- 19 Feb 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 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encapsulated Nutrients' Acute Effects on Appetite
- ClinicalTrials.gov ID
- NCT03284554
- Acronym / sponsor ID
- ENSURE / B342
- Keywords
- Satiety, Nutrients, Appetite, Encapsulation, Lipid, Amino acid, Probiotic bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Arne AstrupUniversity, hospital or other
- Collaborators
- Biocare Copenhagen A/S
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 15 Sep 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 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A double-blind, randomized crossover design with four arms including three experimental conditions and placebo
| Arm | Type | Receives |
|---|---|---|
| Encapsulated nutients | Active comparator | Dietary Supplement: Encapsulated nutrientsEncapsulated 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 | Dietary Supplement: Non-encapsulated nutrientsNutrients 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 | Dietary Supplement: PlaceboNutrients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who have provided written informed consent
- Healthy men
- Age between 18 and 60 years
- BMI between 18.5-32 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
Key exclusion criteria (15 listed)
- Participants unable to consume or known to get nausea from consuming 20 medium sized capsules (placebo capsules will be provided at screening for test of ability to consume the relevant amount of 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
- Significant health problems as judged by the principal investigator
- Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the study professional
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 |
|---|---|---|
| Encapsulated nutrientsAmino acid + Lipid; Probiotic bacteria | Dietary supplement | Encapsulated nutients |
| Non-encapsulated nutrientsAmino acid + Lipid; Probiotic bacteria | Dietary supplement | Non-encapsulated nutrients |
| PlaceboNutrient not expected to stimulate release of GLP-1 and PYY | Dietary supplement | Placebo |
Primary outcome
Reduced energy intake
Time frame: up to day 4
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
2 secondary outcomes
Subjective appetite sensations
Time frame: Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)
Subjective appetite sensations in relation to energy consumed
Time frame: up to day 4
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 19 Feb 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.
Anders Sjödin, MD, PhD principal investigator
University of Copenhagen, Department of Nutrition, Exercise and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Encapsulated nutrients and Non-encapsulated nutrients 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 5 inclusion and 15 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 19 Feb 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?
Reduced energy intake (time frame: up to day 4). 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 19 Feb 2018.