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An exploratory study to measure the postprandial plasma triglyceride levels in breastfed or formula fed healthy infants.

An exploratory study to measure the postprandial plasma triglyceride levels in breastfed or formula fed healthy infants.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24649
Enrollment
60
Registered
2010-05-11
Start date
2010-04-01
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 term infants

Interventions

Infants that are on full formula feeding will join the formula fed group, fully breastfed infants will join the breastfeeding reference group. On the examination day 2 blood samples will be withdraw

Sponsors

Danone Research - Centre for Specialised Nutrition / UMC Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy and full-term infants (gestational age > 37 and < 42 weeks); 2. Birth weight within the normal range for sex and gestational age (10th to 90th percentiles according to locally applicable growth charts); 3. 60 days of age or older; 4. Body weight appropriate for the age of 8 weeks and sex (10th to 90th percentiles according to locally applicable growth charts); 5. Written informed consent of both parent(s)/legal guardian(s).

Exclusion criteria

Exclusion criteria: 1. Infants with known congenital diseases or malfunctions e.g. gastrointestinal malformations, haemophilia; 2. Infants having received medical treatment with antibiotics and/or pain medication like paracetamol which may be included in cough syrup or other mixtures) within 4 days before examination; 3. Infants with abnormal growth (too slow or too fast weight gain) within the 10th to 90th percentiles of locally applicable weight-for-age charts for either boys or girls; 4. Infants needing a special diet other than standard cow's milk-based infant milk formula; 5. Infants having a mother suffering from known hepatitis B, HIV, high blood-pressure, hyperlipidaemia or diabetes; 6. Infants having an overweight (BMI > 27) mother prior to her first pregnancy; 7. Infants with any historical participation in any other study involving investigational or marketed products; 8. Investigator's uncertainty about the willingness or ability of the parent(s)/legal guardian(s) to comply with the protocol requirements and instructions.

Design outcomes

Primary

MeasureTime frame
Postprandial total plasma triglyceride levels at baseline and 30, 60, 90, 120, 180 or 240 minutes after baseline.

Secondary

MeasureTime frame
Differences in total plasma triglyceride levels between 2 feeding regimen (formula feeding vs. breastfeeding), measured at baseline and 30, 60, 90, 120, 180 and 240 minutes after baseline.

Contacts

Public ContactStefanie Schoen

Nutricia Research BV Uppsalalaan 12

stefanie.schoen@danone.com+31 (0)30 2095000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)