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Effects of the diet on human milk composition.


- candidate number12877
- NTR NumberNTR3468
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jun-2012
- Secondary IDs31060 MD Danone Research
- Public TitleEffects of the diet on human milk composition.
- Scientific TitleObservational study on the effect of different dietary habits on human milk quality.
- ACRONYMMedidiet
- hypothesisThe quality of human milk shows an association with the women's diet and lifestyle.
- Healt Condition(s) or Problem(s) studiedBreastfeeding , Healthy subjects
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2012
- planned closingdate1-mei-2013
- Target number of participants300
- InterventionsN/A
- Primary outcome1. Mothers' Diet Index;
2. Mother's anthropometry;
3. Mother's (non)-smoking status;
4. Mother's level of physical activity.
- Secondary outcomeMilk composition parameters.
- TimepointsTime points of the outcome: V1 (5-7 weeks after pregnancy).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Frank Wiens
- CONTACT for SCIENTIFIC QUERIESDr. Frank Wiens
- Sponsor/Initiator Nutricia Research – Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryThe dietary intake of Italian women who have just given birth will be collected via questionnaire. Data on the women's lifestyle, living environment, anthropomerty, and medical history will also be collected. The milk compostion of those women and an association with the dietary habits and the other characteristics of the women will be assessed.
- Main changes (audit trail)
- RECORD14-jun-2012 - 5-aug-2012


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