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

NCT04205045 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-08-01

No results posted yet for this study

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.

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).

Sponsors & Collaborators

  • Paola Vitaglione

    lead OTHER

Principal Investigators

  • Paola Vitaglione, PhD · Federico II University

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-01-24
Completion
2020-01-24

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205045 on ClinicalTrials.gov