ObesityNCT04292236
The Effect of Food Supplements on Food Intake and Gut Hormone Levels
A study testing Lauric Acid, Perilla Oil and Diindolylmethane in people with Obesity and Endocrine; Obesity, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
When a meal is eaten, nutrients activate the release of hormones from the bowel into the blood stream. Normally there is a large amount of hormone released, which tells the brain that an individual is full and to stop eating. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Endocrine; Obesity, Appetite; Perverted
- What is being tested?
- Lauric Acid, Perilla Oil and Diindolylmethane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Feb 2019to 22 Jul 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obese but otherwise healthy volunteers,
- body mass index (BMI) of 30-40 kg/m2
- agreement to consume scheduled meals
- ability to understand the study information sheet and instructions in English and able to provide informed consent.
Who cannot join
- Not meeting any of the exclusion criteria above.
- Major gut surgery
- Major health problems
- Taking medication for diabetes
Trial locations and contacts
1 site in 1 country.
About this study
When a meal is eaten, nutrients activate the release of hormones from the bowel into the blood stream. Normally there is a large amount of hormone released, which tells the brain that an individual is full and to stop eating. When people gain weight and become overweight or obese, these hormone signals are reduced, resulting in these people eating more and gaining more weight. This study is investigating mechanisms which may break this cycle by using particular nutrients to restore reduced hormone levels.
- Conditions
- Obesity, Endocrine; Obesity, Appetite; Perverted
- Being tested
- Lauric Acid, Perilla Oil and Diindolylmethane
- Keywords
- Nutrient, Anorexigenic hormone, Calorific Intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lauric Acid, Perilla Oil and DiindolylmethaneDietary supplement
Colonic release capsules containing lauric acid (2400mg), perilla oil (2100mg) and diinodlylmethane (500mg) given to volunteers 1 hour prior to standardised breakfast and lunch meal. Placebo group given cellulose capsules of same volume prior to standardised breakfast and lunch meal.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Administered at time 0 min and 300 min. Cellulose was used as the placebo. Receives: Dietary Supplement: Lauric Acid, Perilla Oil and Diindolylmethane |
| Dietary Supplement | Active comparator | Administered at 0 min and 300 min. Combination of lauric acid, perilla oil and diindolylmethane was used as the dietary supplement. Receives: Dietary Supplement: Lauric Acid, Perilla Oil and Diindolylmethane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on appetite and satiety ratings
Effect on appetite measured as change in calorific intake
Measured: Study day 1 and study day 2 (following meal intake at breakfast and lunch)
Secondary outcomes (2)
Effect on gut hormone levels
Assess changes to circulating levels of anorectic hormones GLP-1, PYY and orexigenic hormone Ghrelin.
Measured: Study day 1 and study day 2 with samples taken every 30 min
Effect on satiety scores
Using a visual analogue scale measuring changes to hunger, satiety and fullness scores
Measured: Study day 1 and study day 2 (following meal intake at breakfast and lunch)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start22 Feb 2019
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blinded, randomised, crossover, placebo controlled.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madusha Peiris, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292236
- Sponsor's protocol ID
- QMREC2018/20
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peiris M, Aktar R, Reed D, Cibert-Goton V, Zdanaviciene A, Halder W, Robinow A, Corke S, Dogra H, Knowles CH, Blackshaw A. Decoy bypass for appetite suppression in obese adults: role of synergistic nutrient sensing receptors GPR84 and FFAR4 on colonic endocrine cells. Gut. 2022 May;71(5):928-937. doi: 10.1136/gutjnl-2020-323219. Epub 2021 Jun 3.
PubMed 34083384
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Food Supplements on Food Intake and Gut Hormone Levels
- ClinicalTrials.gov ID
- NCT04292236
- Acronym / sponsor ID
- QMREC2018/20
- Conditions
- Obesity, Endocrine; Obesity, Appetite; Perverted
- Keywords
- Nutrient, Anorexigenic hormone, Calorific Intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 3 Mar 2020 (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.
When a meal is eaten, nutrients activate the release of hormones from the bowel into the blood stream. Normally there is a large amount of hormone released, which tells the brain that an individual is full and to stop eating. When people gain weight and become overweight or obese, these hormone signals are reduced, resulting in these people eating more and gaining more weight. This study is investigating mechanisms which may break this cycle by using particular nutrients to restore reduced hormone levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded, randomised, crossover, placebo controlled.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Lauric Acid, Perilla Oil and DiindolylmethaneAdministered at time 0 min and 300 min. Cellulose was used as the placebo. |
| Dietary Supplement | Active comparator | Dietary Supplement: Lauric Acid, Perilla Oil and DiindolylmethaneAdministered at 0 min and 300 min. Combination of lauric acid, perilla oil and diindolylmethane was used as the dietary supplement. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Obese but otherwise healthy volunteers,
- body mass index (BMI) of 30-40 kg/m2
- agreement to consume scheduled meals
- ability to understand the study information sheet and instructions in English and able to provide informed consent.
Key exclusion criteria (4 listed)
- Not meeting any of the exclusion criteria above.
- Major gut surgery
- Major health problems
- Taking medication for diabetes
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 |
|---|---|---|
| Lauric Acid, Perilla Oil and DiindolylmethaneColonic release capsules containing lauric acid (2400mg), perilla oil (2100mg) and diinodlylmethane (500mg) given to volunteers 1 hour prior to standardised breakfast and lunch meal. Placebo group given cellulose capsules of same volume prior to standardised breakfast and lunch meal. | Dietary supplement | Dietary Supplement, Placebo |
Primary outcome
Effect on appetite and satiety ratings
Time frame: Study day 1 and study day 2 (following meal intake at breakfast and lunch)
Effect on appetite measured as change in calorific intake
2 secondary outcomes
Effect on gut hormone levels
Time frame: Study day 1 and study day 2 with samples taken every 30 min
Effect on satiety scores
Time frame: Study day 1 and study day 2 (following meal intake at breakfast and lunch)
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 3 Mar 2020.
- Derived from this study: PubMed 34083384Peiris M, Aktar R, Reed D, Cibert-Goton V, Zdanaviciene A, Halder W, Robinow A, Corke S, Dogra H, Knowles CH, Blackshaw A. Decoy bypass for appetite suppression in obese adults: role of synergistic nutrient sensing receptors GPR84 and FFAR4 on colonic endocrine cells. Gut. 2022 May;71(5):928-937. doi: 10.1136/gutjnl-2020-323219. Epub 2021 Jun 3.
- Individual participant dataSharing planned: No
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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.
Madusha Peiris, PhD principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lauric Acid, Perilla Oil and Diindolylmethane in people with Obesity and Endocrine; Obesity, run by Queen Mary University of London at 1 site in United Kingdom.
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 4 inclusion and 4 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 3 Mar 2020. 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 United Kingdom. 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?
Effect on appetite and satiety ratings (time frame: Study day 1 and study day 2 (following meal intake at breakfast and lunch)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292236, which also lists 1 linked publication.
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 3 Mar 2020.