Diet Induced Intestinal Mucosal Adaptation

NCT02088853 | Completed Results

• 1 other identifier: BUTTER
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Conditions

Keywords

intestinal; metabolic control; mucosa; human; diet

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Glucose Induced Electrogenic Responses In-vitro

  The condition after 2 weeks of each diet

• Glycemic Control Following a Test Meal

  The condition after 2 weeks of each diet

Study Arms (2)

First high fat diet, then high carbohydrate diet

EXPERIMENTAL

had; first sixty percent fat as the energy source, then sixty percent carbohydrates

Dietary Supplement: high fat diet (hfd), then high carbohydrate diet

First, high carb diet, then high fat diet

EXPERIMENTAL

had; first sixty percent carbohydrates as the energy source, the sixty percent fat

Dietary Supplement: high carbohydrate diet, then high fat diet

Interventions

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

First high fat diet, then high carbohydrate diet

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

First, high carb diet, then high fat diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteer not taking prescribed medications BMI ≤25 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital

Gothenburg, SE41345, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35565929 DERIVED

MeSH Terms

Interventions

Diet, High-Fat

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Professor Lars Fandriks
• Organization: Göteborgs University

lars.fandriks@gastro.gu.se

+46313424123

Study Officials

• Lars Fändriks, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-06

Locations

SE (1)