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Diet Induced Intestinal Mucosal Adaptation

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ClinicalTrials.gov Identifier: NCT02088853
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Göteborg University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Conditions Dietary Supplement: high fat diet (hfd) Dietary Supplement: high carb diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Small Intestinal Adaptation to Isocaloric Diets Dominated Either by Fats or Carbohydrates
Study Start Date : March 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: high fat diet Dietary Supplement: high fat diet (hfd)
Sixty % of the energy content is based on fat.
Active Comparator: high carb diet Dietary Supplement: high carb diet
Sixty % of the energy content is based on carbohydrates.


Outcome Measures
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Primary Outcome Measures :
  1. Mucosal surface enlargement factor [ Time Frame: Appearance after 2 weeks of diet ]
    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.


Secondary Outcome Measures :
  1. Epithelial electrical current in-vitro [ Time Frame: The condition after 2 weeks diet ]
    Mucosal biopsies are mounted in minUssing 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.

  2. Mucosal electrical resistance in vitro [ Time Frame: The condition after 2 weeks diet ]
    Mucosal biopsies are mounted in miniUssing chambers. Electrical resistance reflecting paracellular permeability is assessed when switching from glucose-free to glucose-containing luminal solution.

  3. Glycemic control following a test meal [ Time Frame: The condition after 2 weeks diet ]
    Blood concentrations of glucose and insulin are assessed over 2 hours following a mixed test meal.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088853


Locations
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Sweden
Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital
Gothenburg, Sweden, SE41345
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Lars Fändriks, MD, PhD Göteborg University
More Information
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02088853    
Other Study ID Numbers: BUTTER
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Keywords provided by Göteborg University:
intestinal
metabolic control
mucosa
human
diet