Eating BehaviorMicrocapsuleNCT03466047
The Effect of Macronutrients on Satiety and Gut Hormone Responses
A study testing Protein stomach, Protein distal small intestine and CHO stomach in people with Eating Behavior, run by Imperial College London at 1 site in Ireland.
Trial summary
This study is part of a research theme aiming at elucidating the physiological mechanisms of action of weight loss after gastric bypass surgery. The Roux-en-Y Gastric Bypass procedure induces pronounced and sustained weight loss, but the physiological mechanisms of action are not completely clear. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Protein stomach, Protein distal small intestine and CHO stomach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIreland
- Study dates
- 15 Mar 2018to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18-65 years
- Normal fasting glucose
- Stable body weight for at least last three months
- BMI < 30 Kg/m2
- Capacity to consent to participate
- Independently mobile
Who cannot join
- Patients who meet any of the following criteria will be excluded:
- Pre-diabetes Diabetes
- Obesity
- Smoking
- Substance abuse
- Pregnancy
Show all 9Show fewer
- Use of medications (except for oral contraceptives)
- Chronic medical or psychiatric illness
- Any significant abnormalities detected on physical examination, electrocardiography, or screening blood tests (measurement of complete blood count, electrolytes, fasting glucose, and liver function)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Physiological Study on the Effect of Macronutrients Delivery to the Proximal and Distal Small Bowel on Satiety and Gut Hormone Responses
This study is part of a research theme aiming at elucidating the physiological mechanisms of action of weight loss after gastric bypass surgery. The Roux-en-Y Gastric Bypass procedure induces pronounced and sustained weight loss, but the physiological mechanisms of action are not completely clear. Neither mechanical restriction of food intake nor malabsorption, are the main contributing factors. The enhanced postprandial responses of gut hormones (e.g. GLP-1 and PYY) which increase satiety as well as energy expenditure after surgery suggest a changed physiological set point for appetite and metabolism.
Our hypothesis is that the intake of high quantity of protein in a microcapsule form would be able to reach the distal parts of the intestinal mucosa and stimulate maximum stimulation of the anorectic gut hormones. The higher functions of the brain will respond to these strong neuroendocrine signals by ensuing satiety and fullness.
Read the detailed description
Ten healthy volunteers, aged 18 to 65 years will be recruited. Each subject will be studied on six occasions one week apart. On each visit, a baseline serum sample will be drawn from each subject. In a randomized way all subjects will receive the following meals in their successive weekly visits: Option 1 High protein mixed meal in capsules that break down in the stomach, Option 2 High protein mixed meal in capsules that break down in the distal small bowel, Option 3 High fat mixed meal in capsules that break down in the stomach, Option 4 High fat mixed meal in capsules that break down in the distal small bowel, Option 5 High CHD mixed meal in capsules that break down in the stomach, Option 6 High CHD mixed meal in capsules that break down in the distal small bowel. On the same day, all subjects will be offered standard ad libitum meal to measure their food consumption. After 3 hours (i.e. at 12:00) another blood sample will be drawn. All subjects will be asked to rate their appetite on a Visual Analogue Scale (VAS). Upon VAS completion the subjects will be allowed to go home.
- Conditions
- Eating Behavior
- Being tested
- Protein stomach, Protein distal small intestine, CHO stomach, CHO distal small intestine, Fat stomach
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein stomachDietary supplement
encapsulated protein stomach
Protein distal small intestineDietary supplement
encapsulated protein distal small intestine
CHO stomachDietary supplement
encapsulated CHO stomach
CHO distal small intestineDietary supplement
encapsulated CHO distal small intestine
Fat stomachDietary supplement
encapsulated Fat stomach
Fat distal small intestineDietary supplement
encapsulated Fat distal small intestine
| Study group | Role | What they receive |
|---|---|---|
| Protein stomach | Experimental | Encapsulated protein released in the stomach Receives: Dietary Supplement: Protein stomach |
| Protein distal small intestine | Experimental | Encapsulated protein released in the distal small intestine Receives: Dietary Supplement: Protein distal small intestine |
| CHO stomach | Experimental | Encapsulated CHO released in the stomach Receives: Dietary Supplement: CHO stomach |
| CHO distal small intestine | Experimental | Encapsulated CHO released in the distal small intestine Receives: Dietary Supplement: CHO distal small intestine |
| Fat stomach | Experimental | Encapsulated Fat released in the stomach Receives: Dietary Supplement: Fat stomach |
| Fat distal small intestine | Experimental | Encapsulated Fat released in the distal small intestine Receives: Dietary Supplement: Fat distal small intestine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract
3 hours AUC for different gut hormones (PYY) to determine the response to macronutrients in different release (stomach vs small intestine) locations. AUC for timepoints 0, 30min, 60min, 120min, 180min.
Measured: 3 hours
Secondary outcomes (2)
Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake
Food intake as assessed with ad libitum lunch 3 hours after intervention
Measured: 3 hours
Visual Analogue Scale Ratings of Hunger
Visual Analogue Scale ratings of hunger at 180 min (before the meal). The scale is 10cm line with two anchors at each end. Scores are recorded by making a handwritten mark that represents a continuum between "not hungry at all" and "Extremly hungry."
The score of 0 represents least hunger. The score of 10 represent extreme hunger.
Measured: 180min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start15 Mar 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by Imperial College 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carel Le Roux, Imperial College London
- Investigators
- Carel le Roux, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466047
- Sponsor's protocol ID
- Microcapsule
- Acronym
- Microcapsule
- Status last verified
- Sep 2020
- First submitted
- 3 Mar 2018
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physiological Study on the Effect of Macronutrients Delivery to the Proximal and Distal Small Bowel on Satiety and Gut Hormone Responses
- ClinicalTrials.gov ID
- NCT03466047
- Acronym / sponsor ID
- Microcapsule / Microcapsule
- Conditions
- Eating Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is part of a research theme aiming at elucidating the physiological mechanisms of action of weight loss after gastric bypass surgery. The Roux-en-Y Gastric Bypass procedure induces pronounced and sustained weight loss, but the physiological mechanisms of action are not completely clear. Neither mechanical restriction of food intake nor malabsorption, are the main contributing factors. The enhanced postprandial responses of gut hormones (e.g. GLP-1 and PYY) which increase satiety as well as energy expenditure after surgery suggest a changed physiological set point for appetite and metabolism.
Our hypothesis is that the intake of high quantity of protein in a microcapsule form would be able to reach the distal parts of the intestinal mucosa and stimulate maximum stimulation of the anorectic gut hormones. The higher functions of the brain will respond to these strong neuroendocrine signals by ensuing satiety and fullness.
Detailed description
Ten healthy volunteers, aged 18 to 65 years will be recruited. Each subject will be studied on six occasions one week apart. On each visit, a baseline serum sample will be drawn from each subject. In a randomized way all subjects will receive the following meals in their successive weekly visits: Option 1 High protein mixed meal in capsules that break down in the stomach, Option 2 High protein mixed meal in capsules that break down in the distal small bowel, Option 3 High fat mixed meal in capsules that break down in the stomach, Option 4 High fat mixed meal in capsules that break down in the distal small bowel, Option 5 High CHD mixed meal in capsules that break down in the stomach, Option 6 High CHD mixed meal in capsules that break down in the distal small bowel. On the same day, all subjects will be offered standard ad libitum meal to measure their food consumption. After 3 hours (i.e. at 12:00) another blood sample will be drawn. All subjects will be asked to rate their appetite on a Visual Analogue Scale (VAS). Upon VAS completion the subjects will be allowed to go home.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Protein stomach | Experimental | Dietary Supplement: Protein stomachEncapsulated protein released in the stomach |
| Protein distal small intestine | Experimental | Dietary Supplement: Protein distal small intestineEncapsulated protein released in the distal small intestine |
| CHO stomach | Experimental | Dietary Supplement: CHO stomachEncapsulated CHO released in the stomach |
| CHO distal small intestine | Experimental | Dietary Supplement: CHO distal small intestineEncapsulated CHO released in the distal small intestine |
| Fat stomach | Experimental | Dietary Supplement: Fat stomachEncapsulated Fat released in the stomach |
| Fat distal small intestine | Experimental | Dietary Supplement: Fat distal small intestineEncapsulated Fat released in the distal small intestine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 years
- Normal fasting glucose
- Stable body weight for at least last three months
- BMI < 30 Kg/m2
- Capacity to consent to participate
Key exclusion criteria (9 listed)
- Patients who meet any of the following criteria will be excluded:
- Pre-diabetes Diabetes
- Obesity
- Smoking
- Substance abuse
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 |
|---|---|---|
| Protein stomachencapsulated protein stomach | Dietary supplement | Protein stomach |
| Protein distal small intestineencapsulated protein distal small intestine | Dietary supplement | Protein distal small intestine |
| CHO stomachencapsulated CHO stomach | Dietary supplement | CHO stomach |
| CHO distal small intestineencapsulated CHO distal small intestine | Dietary supplement | CHO distal small intestine |
| Fat stomachencapsulated Fat stomach | Dietary supplement | Fat stomach |
| Fat distal small intestineencapsulated Fat distal small intestine | Dietary supplement | Fat distal small intestine |
Primary outcome
The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract
Time frame: 3 hours
3 hours AUC for different gut hormones (PYY) to determine the response to macronutrients in different release (stomach vs small intestine) locations. AUC for timepoints 0, 30min, 60min, 120min, 180min.
2 secondary outcomes
Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake
Time frame: 3 hours
Visual Analogue Scale Ratings of Hunger
Time frame: 180min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Carel le Roux principal investigator
Imperial College 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 Protein stomach, Protein distal small intestine and CHO stomach in people with Eating Behavior, run by Imperial College London at 1 site in Ireland.
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 6 inclusion and 9 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 Oct 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 Ireland. 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. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract (time frame: 3 hours). 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 Oct 2020.