Sucrase-Isomaltase (SI) Genes and Meal Load
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRegion Skane
About this trial
The goal of this interventional study is to examine whether those patients with irritable bowel syndrome (IBS) and a reduced abitility do degrade starch and sugar (lowe levels of enzymes) have lower raise in blood glucose after a meal than those with normal expression of enzymes. We also want to examine whether those IBS patients with reduced enzyme levels have increased bowel symptom in relation to this meal.
The main questions it aims to answer are:
Does reduced ability to degrade starch and sugar due to less enzyme activity lead to lower increase in blood glucose after a meal? Does reduced ability to degrade starch and sugar due to less enzyme activity lead to increased bowel symptoms after a meal?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of irritable bowel syndrome (IBS)
Gene testing has been conducted regarding genes regulating the production of sucrase-isomaltase ensymes in previous dietary interventions using the starch- and sucrose reduced diet (SSRD) or multi-center study.
Disqualifiers
Diagnosis of inflammatory bowel disease, celiac disease, bile salt malabsorption, gastroenteritis or enteric dysmotility
Severe food allergy
Serious heart-, lung-, cardiovascular-, malignant- or mental illness
Ongoing eating disorder
Trial design
Design model
Single group
Treatments tested in this trial
Meal load
Dietary supplementMeal load during 15 minutes
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Meal intakeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes of blood glucose after a meal intake
We will measure blood glucose levels in plasma through a plastic tube. Two samples will be collected before the meal start. One sample 10 minutes before the meal intake and one immediately prior the meal intake. The meal consists of a sugar-rich breakfast, which must be ingested within 15 minutes. Blood samples will then be collected at 10, 20, 30, 45, 60, 90, and 120 minutes afterwards. Blood glucose will be measured at the Department of Clinical Chemistry at the hospital, according to clinical routines.
Time frame
2 hoursSecondary outcomes
1
Changes of gastrointestinal and extraintestinal symptoms after a meal intake assesssed by self-reported completion on visual analog scales
The assessment of changes of gastrointestinal and extraintestinal symptoms will be registered during the breakfast meal. The degree of the symptoms abdominal pain; diarrhea; constipation; bloating/flatulence; vomiting/nausea; belching/excess wind; reflux; headache; back pain; muscle/joint pain; and fatigue will be rated by the participants on 100 mm visual analg scales (VAS); one scale for each symptom. 0 mm means no symptoms and 100 means maximal symptoms. The symptoms will be registered at the same tima as the blood samples will be collected. Thus, participants have to register the symptoms 10 minutes before the meal intake, immediately prior the meal intake, and then 10, 20, 30, 45, 60, 90, and 120 minutes afterwards. These VAS scales are extracted from the validated questionnaires the irritable bowel syndrome-severity symptom score (IBS-SSS) and the visual analg scale for irritable bowel syndrome (VAS-IBS).
Time frame
2 hoursSponsors and contacts
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Source ClinicalTrials.gov