An interventional study of Protein stomach and Protein distal small intestine in Eating Behavior, sponsored by Imperial College London. Completed at 1 site in Ireland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-20.
Sponsored by Imperial College London · Not applicable, Interventional, and Basic science
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.
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's enrollment of 8 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Encapsulated protein released in the stomach
Dietary Supplement: Protein stomach
Encapsulated protein released in the distal small intestine
Dietary Supplement: Protein distal small intestine
Encapsulated CHO released in the stomach
Dietary Supplement: CHO stomach
Encapsulated CHO released in the distal small intestine
Dietary Supplement: CHO distal small intestine
Encapsulated Fat released in the stomach
Dietary Supplement: Fat stomach
Encapsulated Fat released in the distal small intestine
Dietary Supplement: Fat distal small intestine
encapsulated protein stomach
encapsulated protein distal small intestine
encapsulated CHO stomach
encapsulated CHO distal small intestine
encapsulated Fat stomach
encapsulated Fat distal small intestine
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
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
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
| Milestone | Interventions |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
| Milestone | Interventions |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
| Milestone | Interventions |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
| Milestone | Interventions |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
| Milestone | Interventions |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
| Milestone | Interventions |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
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.
| pg*min/mL | Protein Stomach | Fat Stomach | CHO Stomach | Protein Distal Small Intestine | Fat Distal Small Intestine | CHO Distal Small Intestine |
|---|---|---|---|---|---|---|
| The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract | 1310 ± 102 | 1073 ± 154 | 1118 ± 150 | 1188 ± 121 | 1725 ± 351 | 1194 ± 221 |
Food intake as assessed with ad libitum lunch 3 hours after intervention
| kj | Protein Stomach | Protein Distal Small Intestine | CHO Stomach | CHO Distal Small Intestine | Fat Stomach | Fat Distal Small Intestine |
|---|---|---|---|---|---|---|
| Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake | 3138 ± 175 | 3389 ± 161 | 3146 ± 168 | 3008 ± 192 | 3690 ± 170 | 2305 ± 183 |
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.
| cm | Protein Stomach | Protein Small Intestine | CHO Stomach | CHO Small Intestine | Fat Stomach | Fat Small Intestine |
|---|---|---|---|---|---|---|
| Visual Analogue Scale Ratings of Hunger | 5.4 ± 0.5 | 5.5 ± 0.5 | 3.8 ± 0.7 | 4.1 ± 0.6 | 4.1 ± 0.4 | 4.1 ± 0.5 |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Protein Stomach | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Fat Stomach | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| CHO Stomach | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Protein Distal Small Intestine | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Fat Distal Small Intestine | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| CHO Distal Small Intestine | 0/8 (0%) | 0/8 (0%) | 4/8 (50%) |
| Event | Protein Stomach | Fat Stomach | CHO Stomach | Protein Distal Small Intestine | Fat Distal Small Intestine | CHO Distal Small Intestine |
|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 4/8 |
| Loose StoolGastrointestinal disorders | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 4/8 |
| Age, Continuous(years) | Interventions |
|---|---|
| Mean | 28.8 ± 3.5 |
| Sex/Gender, Customized(Participants) | Interventions |
|---|---|
| Women | 3 |
| Race (NIH/OMB)(Participants) | Interventions |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Interventions |
|---|---|
| Ireland | 8 |
| Weight(kg) | Interventions |
|---|---|
| Mean | 81.8 ± 7.2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Jan 2019, 9 months.
Results were first posted in Oct 2020, 1 year 9 months after primary completion.
Of 503 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 9 months is below that.
Counting every sponsor, half of 515 studies reached it within 14 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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