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RECRUITING

NCT07239856

Goat vs. Cow Milk Digestive Tolerance

Sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

View on ClinicalTrials.gov

Summary

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.

Official title: Digestive Tolerance and Nutrient Absorption Kinetics of Goat Milk Versus Cow Milk in Individuals With Reported Cow's Milk Intolerance : a Controlled Single-blinded Crossover Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-25

Completion Date

2027-02

Last Updated

2025-11-20

Healthy Volunteers

Yes

Conditions

Milk Intolerance Milk Hypersensitivity Cow Milk Protein Sensitivity

Interventions

OTHER

Cow 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.

OTHER

Goat Milk

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Pregnant women or those likely to be (based on a positive urine pregnancy test at the time of inclusion) * Excessive alcohol consumption (\>2 drinks/day). Harmful alcohol consumption is assessed by the investigator at the time of inclusion. * Hypertension, diabetes, digestive tract diseases (except for irritable bowel syndrome, IBS), liver or kidney diseases, severe heart disease. The presence of these conditions will be assessed by the investigator based on usual clinical criteria and the volunteers' declarations during inclusion. Hypertension: Significant arterial hypertension as determined by the investigator or systolic blood pressure greater than or equal to 140 mmHg and/or diastolic blood pressure greater than or equal to 90 mmHg on the day of inclusion. Diabetes: Type 1 or Type 2 diabetes or any fasting blood glucose level \> 1.25 g/l. Digestive tract disease: Gastrointestinal disorders deemed by the investigator as clinically significant (bleeding, vomiting, constipation/diarrhea grade \>1), any inflammatory bowel disease, acute gastroenteritis in the month preceding the intervention. Liver disease: Any significant liver disorder as determined by the investigator or any AST/ALT \> 2.5 times the upper normal limit. * Elite athletes (\> 8 hours per week) * Blood donation in the 3 months preceding the start of the study * Participation in a clinical study in the 3 months preceding the study * Lack of free, informed, and express consent

Locations (1)

Hôpital Avicenne, 125 rue de Stalingrad

Bobigny, France