Identification of Physiological Biomarkers of Gastro-intestinal Discomforts Induced by Milk Consumption

CompletedOBSERVATIONAL
Enrollment

40

Participants

Timeline

Start Date

October 1, 2018

Primary Completion Date

January 24, 2020

Study Completion Date

January 24, 2020

Conditions
Healthy Subjects
Interventions
DIAGNOSTIC_TEST

Lactose Breath Test

Lactose Breath Test is performed during the recruitment step. Fasting subjects are asked to ingest 20 g of lactose in a 10% water solution. Breath samples are collected at baseline and every 30 min after lactose ingestion, for an overall test duration of 4 h. A cut-off value of 20 ppm over the baseline will be used to identify lactose malabsorbers.

OTHER

Gut permeability test

A 3-sugar probes test is conducted by administering 5 g lactulose, 2 g mannitol and 2 g sucralose in water solution to fasting subjects. Urine are collected at baseline (before sugar ingestion) and for time periods 0-5 h and 5-24 h.

OTHER

Milk Test

Milk test will be performed by administering to fasting subjects a portion of 250 ml of semi-skimmed milk treated with ultra-high temperature (UHT). Glycaemia measurements, blood withdrawals and questionnaires completion will be performed at baseline and repeated after 30 minutes, 1, 2, 4 and 6 hours after milk ingestion. Urine collection will be performed at baseline and for 6 time intervals after milk ingestion (0-2, 2-4, 4-6, 6-8, 8-12, 12-24 hours).

Trial Locations (1)

80055

Department of Agricultural Sciences, Portici

All Listed Sponsors
lead

Paola Vitaglione

OTHER

NCT04205045 - Identification of Physiological Biomarkers of Gastro-intestinal Discomforts Induced by Milk Consumption | Biotech Hunter | Biotech Hunter