An interventional study of Cow milk and Goat Milk in Milk Intolerance, Milk Hypersensitivity and Cow Milk Protein Sensitivity, sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Not applicable, Interventional, and Basic science
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.
Objective:
Although milk has many nutritional benefits, such as being rich in high-quality proteins and calcium, some people limit or exclude its consumption due to poor digestive tolerance. Lactose intolerance is a well-known cause, but other factors may occur, remaining poorly understood. Goat milk is perceived by consumers as causing fewer intestinal issues than cow milk, particularly for sensitive individuals. However, there is little scientific evidence to support this perception and to confirm the supposed health benefits of goat's milk over cow's milk. 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.
Design:
This study is crossover study, randomized for the order of testing (goat milk or cow milk), conducted in a single-blind design (participants are not informed about the test meal, which is masked by aroma), involving two groups of at least ten volunteers: 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. Each subject will have consumed both milks at the end of the two sessions, with a minimum one-month interval.
Postprandial Test Procedure:
Two days before the test, subjects must exclude consumption of the main dairy products (yogurt, cheese, milk, and custard creams). Volunteers arrive in a fasted state on the investigation day and are hospitalized for one day per session. On the first visit, volunteers bring a stool sample. Upon arrival, body composition is measured via bioelectrical impedance and a venous catheter is inserted. Blood samples are taken 30 minutes pre-meal, every 30 minutes for the first 4 hours, and hourly thereafter, totaling 291 mL. Urine is collected before the meal and every 2 hours post-meal. Respiratory is measured hourly using an indirect calorimeter. Digestive tolerance and hunger are assessed hourly using questionnaires. Volunteers remain semi-reclined for about 9 hours and fast until the experiment ends, receiving hourly water.
The test meal consists of aromatized 500 ml of cow's or goat's milk, labeled with stable isotopes: nitrogen-15 and deuterium. The incorporation rate is minimal and safe for human health, commonly used in clinical studies. The 15N enrichment is measured in collected biological samples (blood, urine) to track the digestive and metabolic fate of dietary amino acids, enabling precise evaluation of nutrient availability kinetics in the body. After the investigation day, volunteers can go home post-meal. A follow-up call the next day checks for digestive symptoms, with the doctor assessing the need for symptomatic treatment.
The protocol has been approved by the Ethical Committee and authorized by the French Agency of Drugs and Health. The personal data management will be in accordance with the regulation on personal data protection ("regulation n° 2018-493 du 20 juin 2018").
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's planned enrollment of 20 is below the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement is the lead sponsor of 50 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals who report being intolerant to cow's milk but not to goat's milk
Other: Cow milk · Other: Goat Milk
Individuals who report being tolerant to both cow's milk and goat's milk.
Other: Cow milk · Other: Goat Milk
Consuption 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.
Consuption 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.
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-meal
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-meal
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-meal
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-meal
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-meal
Exhaled breath gas concentrations from 0 to 8 hours post-meal
Hydrogen (H2), methane (CH4), and carbon dioxide (CO2) concentration from exhaled air
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal
Substrate oxidation rates from 0 to 8 hours post-meal
Fat and glucose oxidation are assessed by measuring respiratory exchanges using indirect calorimetry
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal
Intestinal microbiota composition
Volunteers must bring a stool sample in the container previously provided to them. The samples will be analyzed using the 16S rRNA method to assess gamma and beta diversity.
Time frame: Once at the beginning of enrollement
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Feb 2027, 17 months after the start.
Of 22 interventional studies with no phase under Lactose Intolerance, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's planned 17 months is above that.
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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement