Trial Outcomes & Findings for Diet Induced Intestinal Mucosal Adaptation (NCT NCT02088853)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Appearance after 2 weeks of each diet

Results posted on

2025-07-17

Participant Flow

1 participant had BMI ≥25 kg/m2 and was excluded

Participant milestones

Participant milestones
Measure	First High Fat Diet, Then High Carbo Diet Experimental: First high fat diet, then high carbohydrate diet had; first sixty percent fat as the energy source, then sixty percent carbohydrates	First High Carb Diet, Then High Fay Diet Experimental: First, high carb diet, then high fat diet had; first sixty percent carbohydrates as the energy source, the sixty percent fathigh carb diet: Sixty % of the energy content is based on carbohydrates.
Overall Study STARTED	8	8
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	First High Fat Diet, Then High Carbo Diet Experimental: First high fat diet, then high carbohydrate diet had; first sixty percent fat as the energy source, then sixty percent carbohydrates	First High Carb Diet, Then High Fay Diet Experimental: First, high carb diet, then high fat diet had; first sixty percent carbohydrates as the energy source, the sixty percent fathigh carb diet: Sixty % of the energy content is based on carbohydrates.
Overall Study Pregnancy	1	0

Baseline Characteristics

Diet Induced Intestinal Mucosal Adaptation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=15 Participants The subjects had 2 periods of either 1. first a high fat diet followed by a high carbohydrate diet or 2. first a high carbohydrate diet followed by a high fat diet
Age, Continuous	25 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Appearance after 2 weeks of each diet

Population: healthy volunteers

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.

Outcome measures

Outcome measures
Measure	High Fat Diet n=15 Participants had; sixty percent fat as the energy source high fat diet (hfd): Sixty % of the energy content is based on fat.	High Carb Diet n=15 Participants had; sixty percent carbohydrates as the energy source high carb diet: Sixty % of the energy content is based on carbohydrates.
Mucosal Surface Enlargement	10.2 percentage of muscular mucosae Standard Error 2.0	9.9 percentage of muscular mucosae Standard Error 1.9

SECONDARY outcome

Timeframe: The condition after 2 weeks of each diet

Population: Four pairs of jejunal mucosae were excluded due to technical errors.

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.

Outcome measures

Outcome measures
Measure	High Fat Diet n=11 Participants had; sixty percent fat as the energy source high fat diet (hfd): Sixty % of the energy content is based on fat.	High Carb Diet n=11 Participants had; sixty percent carbohydrates as the energy source high carb diet: Sixty % of the energy content is based on carbohydrates.
Glucose Induced Electrogenic Responses In-vitro	42 % change from baseline Standard Error 12	2 % change from baseline Standard Error 13

SECONDARY outcome

Timeframe: The condition after 2 weeks of each diet

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

Outcome measures

Outcome measures
Measure	High Fat Diet n=15 Participants had; sixty percent fat as the energy source high fat diet (hfd): Sixty % of the energy content is based on fat.	High Carb Diet n=15 Participants had; sixty percent carbohydrates as the energy source high carb diet: Sixty % of the energy content is based on carbohydrates.
Glycemic Control Following a Test Meal	699 mMol/L * 120 min Standard Error 24	732 mMol/L * 120 min Standard Error 25

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Lars Fandriks

Göteborgs University

Phone: +46313424123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place