Hôpital Avicenne, 125 rue de Stalingrad
Bobigny, 93000, France
Location status: Recruiting
NCT Number: NCT07239856
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Bobigny, 93000, France
Location status: Recruiting
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").
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 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
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
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
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, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8 hours post-meal
Analysis of the amino acid, urea, glucose, triglyceride, free fatty acid, cholesterol, and insulin concentrations in blood
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 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
Fat and glucose oxidation are assessed by measuring respiratory exchanges using indirect calorimetry
Time frame: Once at the beginning of enrollement
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.
Contact information is provided by the study sponsor or research team.
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Other
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
Acronym: DIGIGOAT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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