Healthy Conditions
Conditions
Keywords
intestinal, metabolic control, mucosa, human, diet
Brief summary
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.
Interventions
DIETARY_SUPPLEMENThigh fat diet (hfd), then high carbohydrate diet
Sixty % of the energy content is based on fat, then sixty % of the energy content is based on carbohydrates
DIETARY_SUPPLEMENThigh carbohydrate diet, then high fat diet
Sixty % of the energy content is based on carbohydrates, then sixty % of the energy content is based on fat
Sponsors
Sahlgrenska University Hospital
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal Surface Enlargement | Appearance after 2 weeks of each diet | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Induced Electrogenic Responses In-vitro | The condition after 2 weeks of each diet | 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. |
| Glycemic Control Following a Test Meal | The condition after 2 weeks of each diet | Blood concentrations of glucose are assessed over 2 hours following a mixed test meal. |
Countries
Sweden
Participant flow
Pre-assignment details
1 participant had BMI ≥25 kg/m2 and was excluded
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants The subjects had 2 periods of either
1. first a high fat diet followed by a high carbohydrate diet or
2. first a high carbohydrate diet followed by a high fat diet | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Pregnancy | 1 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 2 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: Appearance after 2 weeks of each diet
Population: healthy volunteers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fat Diet | Mucosal Surface Enlargement | 10.2 percentage of muscular mucosae | Standard Error 2 |
| High Carb Diet | Mucosal Surface Enlargement | 9.9 percentage of muscular mucosae | Standard Error 1.9 |
p-value: <0.05Wilcoxon (Mann-Whitney)
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.
Time frame: The condition after 2 weeks of each diet
Population: Four pairs of jejunal mucosae were excluded due to technical errors.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fat Diet | Glucose Induced Electrogenic Responses In-vitro | 42 % change from baseline | Standard Error 12 |
| High Carb Diet | Glucose Induced Electrogenic Responses In-vitro | 2 % change from baseline | Standard Error 13 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Glycemic Control Following a Test Meal
Blood concentrations of glucose are assessed over 2 hours following a mixed test meal.
Time frame: The condition after 2 weeks of each diet
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fat Diet | Glycemic Control Following a Test Meal | 699 mMol/L * 120 min | Standard Error 24 |
| High Carb Diet | Glycemic Control Following a Test Meal | 732 mMol/L * 120 min | Standard Error 25 |
p-value: 0.05Wilcoxon (Mann-Whitney)