The quality of human milk shows an association with the women's diet and lifestyle.
ID
Bron
Verkorte titel
Aandoening
Healthy parturient mothers
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Mothers' Diet Index;<br>
2. Mother's anthropometry;<br>
3. Mother's (non)-smoking status;<br>
4. Mother's level of physical activity.
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
The quality of human milk shows an association with the women's diet and lifestyle.
Onderzoeksopzet
Time points of the outcome: V1 (5-7 weeks after pregnancy).
Onderzoeksproduct en/of interventie
N/A
Publiek
Human Milk Research, Baby Nutrition Division<br>
Milupa GmbH, Bahnstrasse 14-30
Frank Wiens
Friedrichsdorf 61381
Germany
+49 (0)6172 99 1456
frank.wiens@danone.com
Wetenschappelijk
Human Milk Research, Baby Nutrition Division<br>
Milupa GmbH, Bahnstrasse 14-30
Frank Wiens
Friedrichsdorf 61381
Germany
+49 (0)6172 99 1456
frank.wiens@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3321 |
| NTR-old | NTR3468 |
| Ander register | Danone Research : 31060 MD |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |