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Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.
Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. If true, this could conceivably contribute to improved glycemia and body weight. Disparities among studies on food selection and intake are likely due to the almost complete reliance on self-reported food intake which is vulnerable to inaccuracy.This controversy can best be resolved by complementing existing findings with direct measures of target behaviour in humans. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric bypass | Obese patients due to undergo gastric bypass surgery |
| |
| Control | Healthy free-living individuals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Preference | Behavioral | Buffet meal to assess food preference |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Food Intake (Lunch Buffet) at 24 Months | Determine the effect of RYGB on total food intake from an ad libitum lunch buffet | 24 months |
| Change in Absolute Intake of Fat | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of fat from an ad libitum lunch buffet | 24 months |
| Change in Absolute Intake of Carbohydrates | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of carbohydrates from an ad libitum lunch buffet | 24 months |
| Change in Absolute Intake of Sugar | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of sugar from an ad libitum lunch buffet | 24 months |
| Change in Absolute Intake of Protein | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of protein from an ad libitum lunch buffet | 24 months |
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Inclusion Criteria:
Surgical and non-surgical groups:
A) Bariatric surgery B) Controls with no history of bariatric surgery
Independently mobile
Capacity to consent to participate
>18 years of age
Exclusion Criteria:
Pre-operatively: significant dysphagia, gastric outlet obstruction or anything that prevents subjects from eating a meal.
Post-operatively: significant and persistent surgical complications or anything that prevents subjects from eating a meal.
Systemic or gastrointestinal condition which may affect food intake or preference, including:
i) pregnancy or ii) breast feeding.
Active and significant psychiatric illness including substance misuse
Significant cognitive or communication issues
Medications with documented effect on food intake or food preference
History of significant food allergy and certain dietary restrictions
History of liver disease or pancreatitis
History of bradyarrythmia or congestive cardiac failure group)
Use of medications with potential serious interactions with Octreotide
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Patients with obesity attending a specialist obesity clinic and free living individuals.
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| Name | Affiliation | Role |
|---|---|---|
| Carel le Roux, MBChB, PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Dublin | Dublin | Ireland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gastric Bypass | Patients with obesity due to undergo gastric bypass surgery Food Preference: Buffet meal to assess food preference |
| FG001 | Healthy Free-living Individuals | Healthy free-living individuals Food Preference: Buffet meal to assess food preference |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gastric Bypass | Obese patients due to undergo gastric bypass surgery Food Preference: Buffet meal to assess food preference |
| BG001 | Healthy Free-living Individuals | Healthy free-living individuals Food Preference: Buffet meal to assess food preference |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Total Food Intake (Lunch Buffet) at 24 Months | Determine the effect of RYGB on total food intake from an ad libitum lunch buffet | Posted | Mean | Standard Deviation | kJ | 24 months |
|
24 months
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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 | Gastric Bypass | Patients with obesity due to undergo gastric bypass surgery Food Preference: Buffet meal to assess food preference |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Carel le Roux | Imperial College London | 07970719453 | carel.leroux@nhs.net |
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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 | Jun 1, 2016 | Nov 12, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2016 | Feb 15, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D005518 | Food Preferences |
| C564245 | Platelet Glycoprotein IV Deficiency |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Blood- Plasma and Serum
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight (kg) | Mean | Standard Deviation | kg |
|
| Total Food Intake (Lunch Buffet) | The total Intake is calculated based on energy from Fat, Protein, and Carbs. The breakdown includes the energy consumed from Simple Sugar (part of total carbohydrates). | Mean | Standard Deviation | kJ |
|
| Absolute intake of fat | Mean | Standard Deviation | kJ |
|
| Absolute intake of carbohydrates | Mean | Standard Deviation | kJ |
|
| Absolute intake of protein | Mean | Standard Deviation | kJ |
|
| Absolute intake of sugar | Mean | Standard Deviation | kJ |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Change in Absolute Intake of Fat | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of fat from an ad libitum lunch buffet | Posted | Mean | Standard Error | kJ | 24 months |
|
|
|
| Primary | Change in Absolute Intake of Carbohydrates | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of carbohydrates from an ad libitum lunch buffet | Posted | Mean | Standard Error | kJ | 24 months |
|
|
|
| Primary | Change in Absolute Intake of Sugar | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of sugar from an ad libitum lunch buffet | Posted | Mean | Standard Error | kJ | 24 months |
|
|
|
| Primary | Change in Absolute Intake of Protein | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of protein from an ad libitum lunch buffet | Posted | Mean | Standard Error | kJ | 24 months |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Healthy Free-living Individuals | Healthy free-living individuals Food Preference: Buffet meal to assess food preference | 0 | 20 | 0 | 20 | 0 | 20 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D001836 | Body Weight Changes |