Healthy ConditionsNCT02088853

Diet Induced Intestinal Mucosal Adaptation

A study testing high fat diet (hfd), then high carbohydrate diet and high carbohydrate diet, then high fat diet in people with Healthy Conditions, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Conditions
What is being tested?: high fat diet (hfd), then high carbohydrate diet and high carbohydrate diet, then high fat diet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteSweden
Study dates: Mar 2014to Dec 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital
Gothenburg, SE41345

Other trials in Sweden

About this study

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

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
Being tested: high fat diet (hfd), then high carbohydrate diet, high carbohydrate diet, then high fat diet
Keywords: intestinal, metabolic control, mucosa, human, diet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

high fat diet (hfd), then high carbohydrate dietDietary 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 dietDietary supplement
Sixty % of the energy content is based on carbohydrates, then sixty % of the energy content is based on fat

Study groups in NCT02088853
Study group	Role	What they receive
First high fat diet, then high carbohydrate diet	Experimental	had; first sixty percent fat as the energy source, then sixty percent carbohydrates Receives: 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 Receives: Dietary Supplement: high carbohydrate diet, then high fat diet

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Appearance after 2 weeks of each diet

Secondary outcomes (2)

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.
Measured: The condition after 2 weeks of each diet
Glycemic Control Following a Test Meal
Blood concentrations of glucose are assessed over 2 hours following a mixed test meal.
Measured: The condition after 2 weeks of each diet

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Dec 2014

First posted17 Mar 2014 (estimated)
Study startMar 2014
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy ConditionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02088853
Sponsor's protocol ID: BUTTER
Status last verified: Jun 2025
First submitted: 13 Mar 2014
Last updated: 17 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 35565929

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Small Intestinal Adaptation to Isocaloric Diets Dominated Either by Fats or Carbohydrates
ClinicalTrials.gov ID: NCT02088853
Acronym / sponsor ID: BUTTER
Conditions: Healthy Conditions
Keywords: intestinal, metabolic control, mucosa, human, diet
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Göteborg UniversityUniversity, hospital or other
Collaborators: Sahlgrenska University Hospital
Study start: Mar 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 17 Mar 2014 (estimated)
Results: Posted 17 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
First high fat diet, then high carbohydrate diet	Experimental	Dietary Supplement: high fat diet (hfd), then high carbohydrate diethad; first sixty percent fat as the energy source, then sixty percent carbohydrates
First, high carb diet, then high fat diet	Experimental	Dietary Supplement: high carbohydrate diet, then high fat diethad; first sixty percent carbohydrates as the energy source, the sixty percent fat

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
high fat diet (hfd), then high carbohydrate dietSixty % of the energy content is based on fat, then sixty % of the energy content is based on carbohydrates	Dietary supplement	First high fat diet, then high carbohydrate diet
high carbohydrate diet, then high fat dietSixty % of the energy content is based on carbohydrates, then sixty % of the energy content is based on fat	Dietary supplement	First, high carb diet, then high fat diet

Primary outcome

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.

2 secondary outcomes

Glucose Induced Electrogenic Responses In-vitro
Time frame: The condition after 2 weeks of each diet
Glycemic Control Following a Test Meal
Time frame: The condition after 2 weeks of each diet

Results and safety

Results posted to the registry on 17 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
First High Fat Diet, Then High Carbo Diet	8	7
First High Carb Diet, Then High Fay Diet	8	8

Primary outcome: Mucosal Surface Enlargement

Time frame: Appearance after 2 weeks of each diet. Mean (Standard Error). Unit: percentage of muscular mucosae

Measure	High Fat Diet n = 15	High Carb Diet n = 15
Value	10.2 (2.0)	9.9 (1.9)

High Fat Diet vs High Carb Diet: p <0.05, Wilcoxon (Mann-Whitney)

Population analysed: healthy volunteers

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks, in other words: 1w from introductory examination/randomisation, + 2w for the first diet period + 2w for habitual food choice + 2w for the first diet period + 1w for post study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Participants	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35565929Elebring 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lars Fändriks, MD, PhD principal investigator

Göteborg University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing high fat diet (hfd), then high carbohydrate diet and high carbohydrate diet, then high fat diet in people with Healthy Conditions, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mucosal Surface Enlargement (time frame: Appearance after 2 weeks of each diet). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02088853, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.