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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein stomach | Experimental | Encapsulated protein released in the stomach |
|
| Protein distal small intestine | Experimental | Encapsulated protein released in the distal small intestine |
|
| CHO stomach | Experimental | Encapsulated CHO released in the stomach |
|
| CHO distal small intestine | Experimental | Encapsulated CHO released in the distal small intestine |
|
| Fat stomach | Experimental | Encapsulated Fat released in the stomach |
|
| Fat distal small intestine | Experimental | Encapsulated Fat released in the distal small intestine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein stomach | Dietary Supplement | encapsulated protein stomach |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake | Food intake as assessed with ad libitum lunch 3 hours after intervention | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carel le Roux | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Centre | Dublin | Dublin 4 | Ireland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interventions | 6 interventions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Protein Stomach (1day) |
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| Protein Small Intestine (1 Day) |
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| CHO Stomach (1 Day) |
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| CHO Small Intestine (1 Day) |
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| Fat Stomach (1 Day) |
| |||||||||||||
| Fat Small Intestine (1 Day) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interventions | Encapsulated macronutrients in a drink, 6 experiments, Protein released in the stomach (1 day), Protein released in the small intestine (1 day), CHO released in the stomach (1 day), CHO released in the small intestine (1 day), Fat released in the stomach (1 day), fat released in the small intestine (1 day). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | pg*min/mL | 3 hours |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Protein Stomach | encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carel le Roux | Imperial College London | 7970719453 | c.leroux@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2017 | Aug 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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|
| Protein distal small intestine |
| Dietary Supplement |
encapsulated protein distal small intestine |
|
| CHO stomach | Dietary Supplement | encapsulated CHO stomach |
|
| CHO distal small intestine | Dietary Supplement | encapsulated CHO distal small intestine |
|
| Fat stomach | Dietary Supplement | encapsulated Fat stomach |
|
| Fat distal small intestine | Dietary Supplement | encapsulated Fat distal small intestine |
|
| 180min |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG002 | CHO Stomach | encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink |
| OG003 | Protein Distal Small Intestine | encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink |
| OG004 | Fat Distal Small Intestine | encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink |
| OG005 | CHO Distal Small Intestine | encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink |
|
|
| Secondary | Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake | Food intake as assessed with ad libitum lunch 3 hours after intervention | Posted | Mean | Standard Deviation | kj | 3 hours |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | cm | 180min |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Fat Stomach | encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | CHO Stomach | encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Protein Distal Small Intestine | encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink | 0 | 8 | 0 | 8 | 0 | 8 |
| EG004 | Fat Distal Small Intestine | encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink | 0 | 8 | 0 | 8 | 0 | 8 |
| EG005 | CHO Distal Small Intestine | encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink | 0 | 8 | 0 | 8 | 4 | 8 |
| Loose Stool | Gastrointestinal disorders | Systematic Assessment |
|
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