Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
26 October 2021 |
Main ID: |
NCT02088853 |
Date of registration:
|
13/03/2014 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Diet Induced Intestinal Mucosal Adaptation
|
Scientific title:
|
Small Intestinal Adaptation to Isocaloric Diets Dominated Either by Fats or Carbohydrates |
Date of first enrolment:
|
March 2014 |
Target sample size:
|
17 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02088853 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Sweden
| | | | | | | |
Contacts
|
Name:
|
Lars Fändriks, MD, PhD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Göteborg University |
| | |
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Healthy Conditions
|
Intervention(s)
|
Dietary Supplement: high carb diet
|
Dietary Supplement: high fat diet (hfd)
|
Primary Outcome(s)
|
Mucosal surface enlargement factor
[Time Frame: Appearance after 2 weeks of diet]
|
Secondary Outcome(s)
|
Glycemic control following a test meal
[Time Frame: The condition after 2 weeks diet]
|
Mucosal electrical resistance in vitro
[Time Frame: The condition after 2 weeks diet]
|
Epithelial electrical current in-vitro
[Time Frame: The condition after 2 weeks diet]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|