Eating Behavior
Conditions
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTProtein stomach
encapsulated protein stomach
DIETARY_SUPPLEMENTProtein distal small intestine
encapsulated protein distal small intestine
DIETARY_SUPPLEMENTCHO stomach
encapsulated CHO stomach
DIETARY_SUPPLEMENTCHO distal small intestine
encapsulated CHO distal small intestine
DIETARY_SUPPLEMENTFat stomach
encapsulated Fat stomach
DIETARY_SUPPLEMENTFat distal small intestine
encapsulated Fat distal small intestine
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Patients who meet any of the following criteria will be excluded: * Pre-diabetes Diabetes * Obesity * Smoking * Substance abuse * Pregnancy * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake | 3 hours | Food intake as assessed with ad libitum lunch 3 hours after intervention |
| Visual Analogue Scale Ratings of Hunger | 180min | 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. |
Countries
Ireland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Interventions |
|---|---|
| Age, Continuous | 28.8 years STANDARD_DEVIATION 3.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment Ireland | 8 participants |
| Sex/Gender, Customized Women | 3 Participants |
| Weight | 81.8 kg STANDARD_DEVIATION 7.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 4 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
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.
Time frame: 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protein Stomach | The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract | 1310 pg*min/mL | Standard Error 102 |
| Fat Stomach | The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract | 1073 pg*min/mL | Standard Error 154 |
| CHO Stomach | The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract | 1118 pg*min/mL | Standard Error 150 |
| Protein Distal Small Intestine | The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract | 1188 pg*min/mL | Standard Error 121 |
| Fat Distal Small Intestine | The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract | 1725 pg*min/mL | Standard Error 351 |
| CHO Distal Small Intestine | The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract | 1194 pg*min/mL | Standard Error 221 |
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
Time frame: 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protein Stomach | Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake | 3138 kj | Standard Deviation 175 |
| Fat Stomach | Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake | 3389 kj | Standard Deviation 161 |
| CHO Stomach | Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake | 3146 kj | Standard Deviation 168 |
| Protein Distal Small Intestine | Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake | 3008 kj | Standard Deviation 192 |
| Fat Distal Small Intestine | Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake | 3690 kj | Standard Deviation 170 |
| CHO Distal Small Intestine | Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake | 2305 kj | Standard Deviation 183 |
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.
Time frame: 180min
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protein Stomach | Visual Analogue Scale Ratings of Hunger | 5.4 cm | Standard Deviation 0.5 |
| Fat Stomach | Visual Analogue Scale Ratings of Hunger | 5.5 cm | Standard Deviation 0.5 |
| CHO Stomach | Visual Analogue Scale Ratings of Hunger | 3.8 cm | Standard Deviation 0.7 |
| Protein Distal Small Intestine | Visual Analogue Scale Ratings of Hunger | 4.1 cm | Standard Deviation 0.6 |
| Fat Distal Small Intestine | Visual Analogue Scale Ratings of Hunger | 4.1 cm | Standard Deviation 0.4 |
| CHO Distal Small Intestine | Visual Analogue Scale Ratings of Hunger | 4.1 cm | Standard Deviation 0.5 |