Diet Induced Intestinal Mucosal Adaptation

Healthy Conditions Clinical Trial

Official title:

Small Intestinal Adaptation to Isocaloric Diets Dominated Either by Fats or Carbohydrates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088853
• Other study ID #: BUTTER
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2019
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Conditions

Intervention

Dietary Supplement:
• high fat diet (hfd)
Sixty % of the energy content is based on fat.
• high carb diet
Sixty % of the energy content is based on carbohydrates.

Locations

Country	Name	City	State
Sweden	Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucosal surface enlargement factor	The enlargement of the luminal surface area due to the villi structure is a morphometric factor defined as the total area of the mucosal surface in relation to the relatively flat area of the muscular is mucosae.	Appearance after 2 weeks of diet
Secondary	Epithelial electrical current in-vitro	Mucosal biopsies are mounted in min Ussing chambers. Ion-transporting capacity via SGLT-1 transported is reflected when switching from glucose-free to glucose-containing luminal solution, selectivity of transporter is confirmed by addition of phloridzin.	The condition after 2 weeks diet
Secondary	Mucosal electrical resistance in vitro	Mucosal biopsies are mounted in min Ussing chambers. Electrical resistance reflecting paracellular permeability is assessed when switching from glucose-free to glucose-containing luminal solution.	The condition after 2 weeks diet
Secondary	Glycemic control following a test meal	Blood concentrations of glucose and insulin are assessed over 2 hours following a mixed test meal.	The condition after 2 weeks diet