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NCT Number: NCT02088853

Diet Induced Intestinal Mucosal Adaptation

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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Key information

Conditions

Healthy Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital

Gothenburg, SE41345, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Mucosal Surface Enlargement

    Time frame: 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 outcomes

  1. Glucose Induced Electrogenic Responses In-vitro

    Time frame: 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.

  2. Glycemic Control Following a Test Meal

    Time frame: The condition after 2 weeks of each diet

    Blood concentrations of glucose are assessed over 2 hours following a mixed test meal.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2014
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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