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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
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Human beings are 'omnivores' meaning that all principal components of food (i.e. the macronutrients: carbohydrates, fat, proteins) can be assimilated by the gastrointestinal tract. When the gut mucosa is exposed to dietary changes it adjusts its functional behaviour. For example, a fatty diet demands certain digestive mechanisms, whereas others are needed to take care of a carbohydrate rich diet. Such dietary induced changes in appearance and functionality of the small intestinal mucosa have been described in animals but only little is known about it in man. The present project aims at elucidating in man if a 2 weeks diet dominated by either fat or carbohydrates, but with similar energy content, is associated with changes in the small intestinal mucosal appearance and metabolic signalling capacity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First high fat diet, then high carbohydrate diet | Experimental | had; first sixty percent fat as the energy source, then sixty percent carbohydrates |
|
| First, high carb diet, then high fat diet | Experimental | had; first sixty percent carbohydrates as the energy source, the sixty percent fat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high fat diet (hfd), then high carbohydrate diet | Dietary Supplement | Sixty % of the energy content is based on fat, then sixty % of the energy content is based on carbohydrates |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal Surface Enlargement | The enlargement of the luminal surface area is a morphometric factor, defined as the percentage of the mucosal surface (one dimension in arbitrary units) in relation to the relatively flat area of the muscular mucosae layer from the same histological cuts. Unit: % of the muscular mucosae. | Appearance after 2 weeks of each diet |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Induced Electrogenic Responses In-vitro | Jejunal mucosal biopsies are mounted as a sheet between two different (glucose-free) physiological solutions (in so called Ussing chambers). The electrogenic response to glucose will be measured as follows: Baseline ion-transporting capacity for the luminal to serosa side will be measured as the epithelial current (Iep) in the absence of glucose (unit; µA/cm2). Addition of 10mM glucose on the luminal side increases the ion-transporting capacity. This level will be divided with preceding baseline ion-transporting capacity and is presented as % change from the baseline secretion. The sensitivity of this response to phloridzin is given to confirm to what extent the glucose transporter SGLT1 is involved. Only the completed pairs (high fat diet versus high carbohydrate diet) will be analyzed. |
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Inclusion Criteria:
healthy volunteer not taking prescribed medications BMI ≤25 kg/m2
Exclusion Criteria:
BMI ≥26 kg/m2 smoker previous or current gastrointestinal disease significant abdominal surgery pregnancy/breast feeding drug intolerance of importance (particularly opiates and midazolam used during endoscopy) history of drug addiction
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| Name | Affiliation | Role |
|---|---|---|
| Lars Fändriks, MD, PhD | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital | Gothenburg | SE41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35565929 | Derived | Elebring E, Wallenius V, Casselbrant A, Docherty NG, Roux CWL, Marschall HU, Fandriks L. A Fatty Diet Induces a Jejunal Ketogenesis Which Inhibits Local SGLT1-Based Glucose Transport via an Acetylation Mechanism-Results from a Randomized Cross-Over Study between Iso-Caloric High-Fat versus High-Carbohydrate Diets in Healthy Volunteers. Nutrients. 2022 May 7;14(9):1961. doi: 10.3390/nu14091961. |
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1 participant had BMI ≥25 kg/m2 and was excluded
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| ID | Title | Description |
|---|---|---|
| FG000 | First High Fat Diet, Then High Carbo Diet | Experimental: First high fat diet, then high carbohydrate diet had; first sixty percent fat as the energy source, then sixty percent carbohydrates |
| FG001 | First High Carb Diet, Then High Fay Diet | Experimental: First, high carb diet, then high fat diet had; first sixty percent carbohydrates as the energy source, the sixty percent fathigh carb diet: Sixty % of the energy content is based on carbohydrates. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | The subjects had 2 periods of either
|
| 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 | Mucosal Surface Enlargement | The enlargement of the luminal surface area is a morphometric factor, defined as the percentage of the mucosal surface (one dimension in arbitrary units) in relation to the relatively flat area of the muscular mucosae layer from the same histological cuts. Unit: % of the muscular mucosae. | healthy volunteers | Posted | Mean | Standard Error | percentage of muscular mucosae | Appearance after 2 weeks of each diet |
|
8 weeks, in other words: 1w from introductory examination/randomisation, + 2w for the first diet period + 2w for habitual food choice + 2w for the first diet period + 1w for post study.
Healthy, normal weight volunteers
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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 | All Study Participants | had sixty percent fat as the energy source during 2w, then sixty percent carbohydrates during 2w or had sixty percent carbohydrates as the energy source during 2w, then sixty percent fats during 2w |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Lars Fandriks | Göteborgs University | +46313424123 | lars.fandriks@gastro.gu.se |
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| ID | Term |
|---|---|
| D059305 | Diet, High-Fat |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| high carbohydrate diet, then high fat diet | Dietary Supplement | Sixty % of the energy content is based on carbohydrates, then sixty % of the energy content is based on fat |
|
| The condition after 2 weeks of each diet |
| Glycemic Control Following a Test Meal | Blood concentrations of glucose are assessed over 2 hours following a mixed test meal. | The condition after 2 weeks of each diet |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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|
|
| Secondary | Glucose Induced Electrogenic Responses In-vitro | Jejunal mucosal biopsies are mounted as a sheet between two different (glucose-free) physiological solutions (in so called Ussing chambers). The electrogenic response to glucose will be measured as follows: Baseline ion-transporting capacity for the luminal to serosa side will be measured as the epithelial current (Iep) in the absence of glucose (unit; µA/cm2). Addition of 10mM glucose on the luminal side increases the ion-transporting capacity. This level will be divided with preceding baseline ion-transporting capacity and is presented as % change from the baseline secretion. The sensitivity of this response to phloridzin is given to confirm to what extent the glucose transporter SGLT1 is involved. Only the completed pairs (high fat diet versus high carbohydrate diet) will be analyzed. | Four pairs of jejunal mucosae were excluded due to technical errors. | Posted | Mean | Standard Error | % change from baseline | The condition after 2 weeks of each diet |
|
|
|
|
| Secondary | Glycemic Control Following a Test Meal | Blood concentrations of glucose are assessed over 2 hours following a mixed test meal. | Posted | Mean | Standard Error | mMol/L * 120 min | The condition after 2 weeks of each diet |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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