Goat vs. Cow Milk Digestive Tolerance

NCT07239856 | Recruiting

• 1 other identifier: DIGIGOAT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Milk Intolerance; Milk Hypersensitivity; Cow Milk Protein Sensitivity

Keywords

Digestive confort; Goat milk; Cow milk; Stable isotopes; Milk hypersensitivity; Milk intolerance; Digestion

Outcome Measures

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.

  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

  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

  0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal

• 2H enrichment of plasma glucose from 0 to 8 hours post-meal

  0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal

• Blood metabolites concentrations from 0 to 8 hours post-meal

  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

  0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-meal

Study Arms (2)

Cow milk intolerant

EXPERIMENTAL

Individuals who report being intolerant to cow's milk but not to goat's milk

Other: Cow milk; Other: Goat Milk

Control

EXPERIMENTAL

Individuals who report being tolerant to both cow's milk and goat's milk.

Other: Cow milk; Other: Goat Milk

Interventions

Cow milk OTHER

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.

Control; Cow milk intolerant

Goat Milk OTHER

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.

Control; Cow milk intolerant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Hôpital Avicenne, 125 rue de Stalingrad

Bobigny, 93000, France

RECRUITING

MeSH Terms

Conditions

Lactose Intolerance; Milk Hypersensitivity

Interventions

Milk

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Central Study Contacts

Saviard

CONTACT

+33631312326; tanguy.saviard@agroparistech.fr

Maurinier

CONTACT

+33148957433; suzette.maurinier@agroparistech.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: November 20, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)