Appetite RegulationNCT03025997
Lipid Encapsulation for Ileal Brake Activation
A study testing Active yoghurt in people with Appetite Regulation, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two treatments (active, and placebo) on two different days, following a randomized cross-over design. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation
- What is being tested?
- Active yoghurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jan 2017to 31 Mar 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 25-30 kg/m2
- Voluntary participation
Who cannot join
- Milk (-protein or lactose)- allergy/intolerance
- History of serious GI complaints/surgeries
- Pregnancy, lactation
- Excessive alcohol consumption (>20 per week)
- Abnormal eating behaviour
- Intention to stop smoking
- Reported unexplained weight loss or gain in the month prior to screening
- Self-admitted HIV-positive state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Orally Applied Encapsulated Lipids in Yoghurt on Satiety and Food Intake: a Randomized Single-blind Placebo-controlled Study With Cross-over Design
This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two treatments (active, and placebo) on two different days, following a randomized cross-over design.
- Conditions
- Appetite Regulation
- Being tested
- Active yoghurt, Placebo yoghurt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active yoghurtDietary supplement
Active yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.
Placebo yoghurtDietary supplement
Placebo yoghurt (containing non-encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Active yoghurt | Active comparator | Yoghurt snack containing encapsulated lipid Receives: Dietary Supplement: Active yoghurt |
| Placebo yoghurt | Placebo comparator | Yoghurt snack containing non-encapsulated lipid
+ empty encapsulation matrix Receives: Dietary Supplement: Placebo yoghurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
ad libitum food intake
t=0: standardized breakfast, t=90 minutes: yoghurt, t=210 minutes: ad libitum food intake
Measured: 2 hours after yoghurt snack
Secondary outcomes (2)
Satiety feelings
Every 15-30 min, 5 attributes will be measured on a Visual Analogue Scale
Measured: Up to 3.5 hours on each of the 2 test days.
occurrence and severity of GI symptoms
Every 15-30 min, 4 attributes will be measured on a Visual Analogue Scale
Measured: Up to 3.5 hours on each of the 2 test days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start24 Jan 2017
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite RegulationStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University and Research
- Responsible party
- Sponsor
- Investigators
- Adrian AM Masclee, Prof., Principal investigator, azM/UM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025997
- Sponsor's protocol ID
- NL59245.068.16
- Other IDs
- 163042
- Status last verified
- Mar 2017
- First submitted
- 6 Jan 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Orally Applied Encapsulated Lipids in Yoghurt on Satiety and Food Intake: a Randomized Single-blind Placebo-controlled Study With Cross-over Design
- ClinicalTrials.gov ID
- NCT03025997
- Acronym / sponsor ID
- NL59245.068.16
- Conditions
- Appetite Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Wageningen University and Research
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 20 Jan 2017 (estimated)
- 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.
This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two treatments (active, and placebo) on two different days, following a randomized cross-over design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active yoghurt | Active comparator | Dietary Supplement: Active yoghurtYoghurt snack containing encapsulated lipid |
| Placebo yoghurt | Placebo comparator | Dietary Supplement: Placebo yoghurtYoghurt snack containing non-encapsulated lipid + empty encapsulation matrix |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI between 25-30 kg/m2
- Voluntary participation
Key exclusion criteria (8 listed)
- Milk (-protein or lactose)- allergy/intolerance
- History of serious GI complaints/surgeries
- Pregnancy, lactation
- Excessive alcohol consumption (>20 per week)
- Abnormal eating behaviour
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 |
|---|---|---|
| Active yoghurtActive yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured. | Dietary supplement | Active yoghurt |
| Placebo yoghurtPlacebo yoghurt (containing non-encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured. | Dietary supplement | Placebo yoghurt |
Primary outcome
ad libitum food intake
Time frame: 2 hours after yoghurt snack
t=0: standardized breakfast, t=90 minutes: yoghurt, t=210 minutes: ad libitum food intake
2 secondary outcomes
Satiety feelings
Time frame: Up to 3.5 hours on each of the 2 test days.
occurrence and severity of GI symptoms
Time frame: Up to 3.5 hours on each of the 2 test days.
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 20 Nov 2017.
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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.
Adrian AM Masclee, Prof. principal investigator
azM/UM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active yoghurt in people with Appetite Regulation, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 8 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 20 Nov 2017. 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 Netherlands. 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?
ad libitum food intake (time frame: 2 hours after yoghurt snack). 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 20 Nov 2017.