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NCT Number: NCT03062761

A Clinical Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants

It is universally accepted that the best nutrition for a new-born infant is breast milk. Breast milk provides a complete set of nutrients to support growth and development of children in early life, including components that have a beneficial effect on gut health and the body's ability to defend itself against infectious organisms and other invaders (immune system).However, it may occur that a mother is unable to breastfeed her child, or chooses not to breastfeed. In such cases, an infant formula inspired by breast milk is the best alternative. Research is done to optimize milk formula for infants. One of these formulas contains 'partially hydrolyzed' proteins instead of intact proteins, meaning the proteins in this formula are broken down into smaller pieces. These smaller pieces of protein make the milk more suitable for consumption by infants at risk of developing cow's milk allergy. These types of partially hydrolyzed protein formulas have been on the market for several years, in particular for children with a family risk of allergy. So far, no safety related issues have been reported. It is also known that weight gain of infants receiving partially hydrolyzed proteins in general is appropriate according to the World Health Organisation growth standards.

The main purpose of the TENUTO study is to demonstrate that infants who receive a specific partially hydrolyzed protein infant formula for the first 4 months of life have a similar weight gain compared to infants receiving standard infant formula with intact proteins. A group of infants who receive breast milk only is also included for comparison.

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Key information

Conditions

Growth

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Turku Children's Allergy and Asthma Clinic, Turku, Finland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy term infants (gestational age ≥ 37 weeks + 0 days and ≤ 41 weeks + 6 days);
  • Infants' age at enrolment ≤ 14 days;
  • Birth weight within normal range for gestational age and sex (10th to 90th percentile according to the WHO Child Growth Standards - or local growth standards if available);
  • Head circumference at inclusion within normal range for age and sex (within 2 SD curves according to WHO Child Growth Standards - or local growth standards if available);
  • Infant formula arms: infants who are exclusively formula fed by time of randomisation with a maximum infants' age of 14 days (infants of mothers who choose not to breastfeed or mothers who cease breastfeeding for any reason before the infant is 14 days of age); OR Breastfeeding reference arm: infants who are exclusively breastfed and whose mothers are intending to exclusively breastfeed their infant at least until the infant is 17 weeks of age; 6 Written informed consent from parent(s) and/or legal guardian(s) aged ≥ 18 years.

Exclusion criteria

Infants of pregnant women/mothers:

  • who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
  • known to have a significant medical condition (including during pregnancy) that might interfere with the study or known to affect intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication), as per investigator's clinical judgement;

Infants of parents:

  • who are incapable to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;

Infants:

  • who have to be fed with a special diet other than standard (non-hydrolysed) cow's milk based infant formula
  • known to have current or previous illnesses/conditions which could interfere with the study or its outcome parameters, such as gastrointestinal malformations, congenital metabolic disorders, immune deficiency or major surgery, as per investigator's clinical judgement;
  • with any history of, or current participation in any other study involving investigational or marketed products.

Treatment and study plan

Infant Formula with prebiotics

Other

Intervention group: Partially hydrolysed whey protein based infant formula containing prebiotics.

Standard Infant Formula

Other

Control group: Intact cow's milk protein based infant formula containing prebiotics

Primary outcomes

  1. Weight gain

    Time frame: 17 weeks

    Weight gain in grams per day from baseline until 17 weeks of age

Secondary outcomes

  1. Length

    Time frame: 17 weeks

    Gain in Recumbent length (mm/day)

  2. Head circumference

    Time frame: 17 weeks

    Gain in Head circumference (mm/day)

  3. Mid-upper arm circumference

    Time frame: 17 weeks

    Gain in Mid-upper arm circumference (mm/day)

  4. Anthropometric measures

    Time frame: 17 weeks

    Z scores of anthropometric parameters

  5. Albumin level

    Time frame: 17 weeks

    Albumin in blood (g/L)

  6. Calcium level

    Time frame: 17 weeks

    Calcium in blood (mmol/l)

  7. Phosphorus level

    Time frame: 17 weeks

    Phosphorus in blood (mmol/l)

  8. Iron level

    Time frame: 17 weeks

    Iron (µmol/l) in blood

  9. Magnesium level

    Time frame: 17 weeks

    Magnesium (mmol/l) in blood

  10. Nitrogen level

    Time frame: 17 weeks

    Blood urea nitrogen (mmol/l)

  11. Number of subjects with adverse events

    Time frame: 17 weeks

    Adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA ) will be reported as number of subjects with at least one adverse event

  12. Number of adverse events

    Time frame: 17 weeks

    Number of adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA)

  13. Concomitant medications

    Time frame: 17 weeks

    All concomitant medications (according to WHO-DDE) will be summarised in individual data listing

  14. Regurgitation

    Time frame: 4, 8, 13 and 17 weeks

    Regurgitation nr of occurrences per week

  15. Vomiting

    Time frame: 4, 8, 13 and 17 weeks

    Vomiting nr of occurrences per week

  16. Diarrhoea

    Time frame: 4, 8, 13 and 17 weeks

    Number of infants with diarrhoea (definition adapted from WHO definition based on number of watery stools per day)

  17. Constipation

    Time frame: 4, 8, 13 and 17 weeks

    Number of infants with constipation (definition adapted from Rome II criteria based on number of defecations and consistency per week)

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Official study title

A Randomized, Controlled, Double Blind, Parallel Group, Multi-country Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants

Acronym: TENUTO

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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