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Effects of the diet on human milk composition.

Observational study on the effect of different dietary habits on human milk quality.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29542
Enrollment
300
Registered
2012-06-14
Start date
2012-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy parturient mothers

Interventions

None listed

Sponsors

Danone Research - centre for Specialised Nutrition
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Italian women aged between 25 and 40; 2. Given birth to term born babies; 3. Written informed consent; 4. Willingness and capability to comply with protocol requirements and procedures.

Exclusion criteria

Exclusion criteria: 1. Alcohol abuse; 2. Underlying disease requiring medical intervention; 3. History of blood transfusion; 4. Use of drugs or pharmacologically active substances; 5. Presence of acute infection disease or neoplastic disease or any kind of weakening and debilitating conditions; 6. Mastitis, fungal infections of the nipple or areola; 7. Reactivation of herpex simplex (HSV) or varicella zoster infections in the mammary or thoracic region; 8. Presence of endocrinologic diseases, particularly diabetes mellitus; 9. Presence of metabolic diseases, particularly obesity; 10. Presence of chronic diseases: renal, cardiovascular, hypertension; 11. Elimination diet due to chronic allergic diseases or vegan; 12. Presence of one of the following autoimmune diseases: systemic lupus eritematosus, systemic scleroderma, colitis ulcerosa, Crohn’s disease, celiac disease; 13. Participation in other clinical studies; 14. Women whose health condition, according to the investigator’s judgment, could compromise the participation in the study.

Design outcomes

Primary

MeasureTime frame
1. Mothers' Diet Index; 2. Mother's anthropometry; 3. Mother's (non)-smoking status; 4. Mother's level of physical activity.

Secondary

MeasureTime frame
Milk composition parameters.

Contacts

Public ContactFrank Wiens

Danone Research - Centre for Specialised Nutrition Human Milk Research, Baby Nutrition Division Milupa GmbH, Bahnstrasse 14-30

frank.wiens@danone.com+49 (0)6172 99 1456

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)