Goat vs. Cow Milk Digestive Tolerance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
About this trial
The objective of this study is to assess to what extent goat's milk is better tolerated than cow's milk among individuals who report being intolerant to cow's milk, and, if so, to understand the underlying factors. To achieve this, digestive discomfort sensations and postprandial kinetics of nutrients after ingestion of cow's or goat's milk will be compared in two populations: individuals intolerant to cow's milk but not to goat's milk, and individuals who show no symptoms of intolerance to either cow's or goat's milk. For this purpose, approaches based on stable isotope labeling of milk will be employed.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals who report being intolerant to cow milk but not to goat milk (one group) or tolerant to both cow milk and goat milk (another group)
Good general health (WHO grade = 0)
Affiliated with a social security scheme
Free, informed, and express consent, in accordance with the public health code: 'No research mentioned in 2° of Article L. 1121-1 can be conducted on a person without their free, informed, and express consent.
Disqualifiers
Individuals under guardianship or curatorship
Individuals under legal protection
Any known food allergies
Anemia: hemoglobin levels below 13 g/dL for men and 12 g/dL for women
Trial design
Design model
Crossover
Treatments tested in this trial
Cow milk
Other interventionConsuption of 500 ml of aromatized cow milk, labeled with stable isotopes: nitrogen-15 and deuterium. Body composition is measured via bioelectrical impedance. A venous catheter is inserted. Blood, urine and breath samples are taken pre-meal, and regularly during 8 hours. Digestive tolerance and hunger are assessed using questionnaires.
Goat Milk
Other interventionConsuption of 500 ml of aromatized goat milk, labeled with stable isotopes: nitrogen-15 and deuterium. Body composition is measured via bioelectrical impedance. A venous catheter is inserted. Blood, urine and breath samples are taken pre-meal, and regularly during 8 hours. Digestive tolerance and hunger are assessed using questionnaires.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Cow milk intolerantExperimental treatment 2 interventions
Group B: ControlExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Digestive discomfort score from 0 to 8 hours post-meal
A digestive tolerance questionnaire (Casellas, 2009) and a hunger sensation questionnaire using visual analog scales are administered hourly. These are based on scales from 1 to 10 to assess feelings of : flatulence, nausea, diarrhea, bloating, and abdominal pain.
Time frame
0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-mealSecondary outcomes
1
15N enrichment of plasma and urine fractions from 0 to 8 hours post-meal
The measurement of isotopic enrichment of nitrogenous compounds in plasma and urine, in response to the ingestion of 15N-labeled milk proteins, provides an estimate of proteins absorption kinetic.
Time frame
0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal2
2H enrichment of plasma fatty acids from 0 to 8 hours post-meal
The measurement of isotopic enrichment of fatty acids in plasma, in response to the ingestion of 2H-labeled milk lipids, provides an estimate of fatty acid absorption kinetics.
Time frame
0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal3
2H enrichment of plasma glucose from 0 to 8 hours post-meal
The measurement of isotopic enrichment of glucose in plasma, in response to the ingestion of 2H-labeled milk lactose, provides an estimate of lactose absorption kinetics.
Time frame
0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal4
Blood metabolites concentrations from 0 to 8 hours post-meal
Analysis of the amino acid, urea, glucose, triglyceride, free fatty acid, cholesterol, and insulin concentrations in blood
Time frame
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8 hours post-mealSponsors and contacts
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Source ClinicalTrials.gov