Milk IntoleranceDIGIGOATNCT07239856
Goat vs. Cow Milk Digestive Tolerance
A study testing Cow milk and Goat Milk in people with Milk Intolerance and Milk Hypersensitivity, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Milk Intolerance, Milk Hypersensitivity, Cow Milk Protein Sensitivity
- What is being tested?
- Cow milk and Goat Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Avicenne, 125 rue de Stalingrad
Bobigny, 93000
Benallaoua, +33148957433, mourad.benallaoua@aphp.fr
About this study
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
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.
Read the detailed description
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").
- Being tested
- Cow milk, Goat Milk
- Keywords
- Digestive confort, Goat milk, Cow milk, Stable isotopes, Milk hypersensitivity, Milk intolerance, Digestion
- Medical subject headings
- Lactose Intolerance, Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cow milkOther
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.
Goat MilkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cow milk intolerant | Experimental | Individuals who report being intolerant to cow's milk but not to goat's milk Receives: Other: Cow milk; Other: Goat Milk |
| Control | Experimental | Individuals who report being tolerant to both cow's milk and goat's milk. Receives: Other: Cow milk; Other: Goat Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Once at the beginning of enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start25 Sep 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Milk IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239856
- Sponsor's protocol ID
- DIGIGOAT
- Acronym
- DIGIGOAT
- Status last verified
- May 2025
- First submitted
- 11 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07239856
- Acronym / sponsor ID
- DIGIGOAT / DIGIGOAT
- Keywords
- Digestive confort, Goat milk, Cow milk, Stable isotopes, Milk hypersensitivity, Milk intolerance, Digestion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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").
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cow milk intolerant | Experimental | Other: Cow milk, Other: Goat MilkIndividuals who report being intolerant to cow's milk but not to goat's milk |
| Control | Experimental | Other: Cow milk, Other: Goat MilkIndividuals who report being tolerant to both cow's milk and goat's milk. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cow milkConsuption 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 | Control, Cow milk intolerant |
| Goat MilkConsuption 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. | Other | Control, Cow milk intolerant |
Primary outcome
Digestive discomfort score from 0 to 8 hours post-meal
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.
7 secondary outcomes
15N enrichment of plasma and urine fractions from 0 to 8 hours post-meal
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
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
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal
Blood metabolites concentrations from 0 to 8 hours post-meal
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
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal
Substrate oxidation rates from 0 to 8 hours post-meal
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal
Intestinal microbiota composition
Time frame: Once at the beginning of enrollement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cow milk and Goat Milk in people with Milk Intolerance and Milk Hypersensitivity, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saviard (+33631312326, tanguy.saviard@agroparistech.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digestive discomfort score from 0 to 8 hours post-meal (time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.