Obesity
Conditions
Keywords
Food preferences, Fat, Weight loss
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFood Preference
Buffet meal to assess food preference
Sponsors
Imperial College London
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Surgical and non-surgical groups: A) Bariatric surgery B) Controls with no history of bariatric surgery 2. Independently mobile 3. Capacity to consent to participate 4. \>18 years of age
Exclusion criteria
1. Pre-operatively: significant dysphagia, gastric outlet obstruction or anything that prevents subjects from eating a meal. 2. Post-operatively: significant and persistent surgical complications or anything that prevents subjects from eating a meal. 3. Systemic or gastrointestinal condition which may affect food intake or preference, including: i) pregnancy or ii) breast feeding. 4. Active and significant psychiatric illness including substance misuse 5. Significant cognitive or communication issues 6. Medications with documented effect on food intake or food preference 7. History of significant food allergy and certain dietary restrictions 8. History of liver disease or pancreatitis 9. History of bradyarrythmia or congestive cardiac failure group) 10. Use of medications with potential serious interactions with Octreotide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Food Intake (Lunch Buffet) at 24 Months | 24 months | Determine the effect of RYGB on total food intake from an ad libitum lunch buffet |
| Change in Absolute Intake of Fat | 24 months | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of fat from an ad libitum lunch buffet |
| Change in Absolute Intake of Carbohydrates | 24 months | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of carbohydrates from an ad libitum lunch buffet |
| Change in Absolute Intake of Sugar | 24 months | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of sugar from an ad libitum lunch buffet |
| Change in Absolute Intake of Protein | 24 months | Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of protein from an ad libitum lunch buffet |
Countries
Ireland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gastric Bypass Obese patients due to undergo gastric bypass surgery
Food Preference: Buffet meal to assess food preference | 14 |
| Healthy Free-living Individuals Healthy free-living individuals
Food Preference: Buffet meal to assess food preference | 20 |
| Total | 34 |
Baseline characteristics
| Characteristic | Gastric Bypass | Healthy Free-living Individuals | Total |
|---|---|---|---|
| Absolute intake of carbohydrates | 3102.4 kJ STANDARD_DEVIATION 1080 | 300 kJ STANDARD_DEVIATION 70 | 1701.2 kJ STANDARD_DEVIATION 575 |
| Absolute intake of fat | 2617.1 kJ STANDARD_DEVIATION 250 | 310 kJ STANDARD_DEVIATION 30 | 1448.5 kJ STANDARD_DEVIATION 265 |
| Absolute intake of protein | 833.9 kJ STANDARD_DEVIATION 87 | 190 kJ STANDARD_DEVIATION 15 | 511.95 kJ STANDARD_DEVIATION 94.5 |
| Absolute intake of sugar | 1312.5 kJ STANDARD_DEVIATION 300 | 180 kJ STANDARD_DEVIATION 30 | 746.25 kJ STANDARD_DEVIATION 315 |
| Age, Continuous | 51.0 years STANDARD_DEVIATION 7.8 | 28 years STANDARD_DEVIATION 4.1 | 39.5 years STANDARD_DEVIATION 5.95 |
| Body weight (kg) | 136 kg STANDARD_DEVIATION 23.8 | 65 kg STANDARD_DEVIATION 5.2 | 100.5 kg STANDARD_DEVIATION 14.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 20 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Ireland | 14 participants | 20 participants | 34 participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 12 Participants |
| Total Food Intake (Lunch Buffet) | 6510.3 kJ STANDARD_DEVIATION 1023 | 800 kJ STANDARD_DEVIATION 50 | 3655 kJ STANDARD_DEVIATION 536.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 20 |
| other Total, other adverse events | 0 / 14 | 0 / 20 |
| serious Total, serious adverse events | 0 / 14 | 0 / 20 |
Outcome results
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
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gastric Bypass | Change in Absolute Intake of Carbohydrates | -2088.6 kJ | Standard Error 370.1 |
| Healthy Free-living Individuals | Change in Absolute Intake of Carbohydrates | 280 kJ | Standard Error 40.3 |
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
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gastric Bypass | Change in Absolute Intake of Fat | -1549.7 kJ | Standard Error 298.9 |
| Healthy Free-living Individuals | Change in Absolute Intake of Fat | 301 kJ | Standard Error 70.1 |
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
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gastric Bypass | Change in Absolute Intake of Protein | -360.7 kJ | Standard Error 91.4 |
| Healthy Free-living Individuals | Change in Absolute Intake of Protein | 140.2 kJ | Standard Error 35.2 |
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
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gastric Bypass | Change in Absolute Intake of Sugar | -890.7 kJ | Standard Error 258.1 |
| Healthy Free-living Individuals | Change in Absolute Intake of Sugar | 160.0 kJ | Standard Error 39.8 |
Primary
Total Food Intake (Lunch Buffet) at 24 Months
Determine the effect of RYGB on total food intake from an ad libitum lunch buffet
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gastric Bypass | Total Food Intake (Lunch Buffet) at 24 Months | 2540.1 kJ | Standard Deviation 431 |
| Healthy Free-living Individuals | Total Food Intake (Lunch Buffet) at 24 Months | 721 kJ | Standard Deviation 201 |