Identification of Physiological Biomarkers of Gastro-intestinal Discomforts Induced by Milk Consu… (NCT04205045) | Clinical Trial Compass
CompletedNot Applicable
Identification of Physiological Biomarkers of Gastro-intestinal Discomforts Induced by Milk Consumption
Italy40 participantsStarted 2018-10-01
Plain-language summary
This study aims to explore digestibility of lactose and milk proteins, gut permeability, microbiota composition and psychological wellbeing status in healthy subjects who are non-habitual milk consumers due to milk-related gastro-intestinal discomfort in comparison with healthy and habitual milk consumers.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Drinking milk (maximum 150 ml/week for non-habitual milk consumers and minimum of 700 ml/week for habitual milk consumers)
* BMI between 18.5 - 30 kg/m2
* Available for three visits (with one week in between).
* Willing to drink 250 ml of milk in fasting condition within 10 min
* Written informed consent
* Negative lactose breath test result (increase in H2 concentrations \< 20 ppm vs basal value) and without symptoms or with any symptoms except "vomiting" and "Loose, mushy or watery stools"
* Lactose malabsorbers (increase in H2 concentrations \> 20 ppm vs basal value but without symptoms)
Exclusion Criteria:
* Presence of any relevant organic, systemic or metabolic disease or abnormal laboratory values.
* Ascertained intestinal organic diseases, including celiac disease or inflammatory bowel diseases.
* Previous major abdominal surgeries.
* Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable).
* Untreated food intolerance.
* Lactose intolerant
* Assumption of probiotics or topic and/or systemic antibiotic therapy during the last month.
* Systematical/frequent assumption of contact laxatives.
* Pregnant and lactating women.
* Inability to conform with protocol.
* Treatment with any investigational drug within the previous 30 days.
* Recent history or suspicion …
What they're measuring
1
Changes from baseline in plasmatic concentration of milk-derived peptides following milk ingestion.
Timeframe: baseline and at 0.5, 1, 2, 4 and 6 hours after milk ingestion.
2
Changes from baseline of insulin plasmatic levels following milk ingestion.
Timeframe: baseline and at 0.5, 1, 2, 4 and 6 hours after milk ingestion.
3
Changes from baseline of glucose-dependent insulinotropic peptide (GIP) plasmatic levels following milk ingestion.
Timeframe: baseline and at 0.5, 1, 2, 4 and 6 hours after milk ingestion.
4
Changes from baseline of glucagon-like peptide 1 (GLP-1) plasmatic levels following milk ingestion.
Timeframe: baseline and at 0.5, 1, 2, 4 and 6 hours after milk ingestion.
5
Changes from baseline of glucagon plasmatic levels following milk ingestion.
Timeframe: baseline and at 0.5, 1, 2, 4 and 6 hours after milk ingestion.
6
Changes from baseline of c-peptide plasmatic levels following milk ingestion.
Timeframe: baseline and at 0.5, 1, 2, 4 and 6 hours after milk ingestion.
7
Changes from baseline of ghrelin plasmatic levels following milk ingestion.