An Exploratory Trial in Hong Kong to Explore the Effect of a New Formula
Study Details
Study Description
Brief Summary
This is an exploratory study with the aim to gain insight and potentially generate hypotheses on health benefits of feeding with study product. This study explores in healthy subjects (Infants aged 6 months at enrolment) the effect of feeding with the test product compared to the control product.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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Key exploratory objective is to find an effect on body composition.
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Other exploratory objectives are to find an effect on growth, microbiome, eating behavior, and quality of life, etc.
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Safety and tolerance and the user experience will be investigated.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test products: FOF (6-9 months of age): 6 scoops in 180 ml water, 4 times/day FOF (9-12 months of age): 7 scoops in 210 ml water, 3 times/day YCF (1-1.5 years of age): 5 scoops in 150 ml water, 3 times/day |
Other: Test Formula
The duration of the study for each subject from enrolment to final visit, is 12 months. Test Formula will be provided during this 12 month.
After having signed for informed consent, screening of in- and exclusion criteria will be done. Subjects eligible for participation will be enrolled in the study and have their Visit 1 (enrolment / baseline visit). After visit 1, two more study visits will take place at six months (Visit 2) and twelve months (Visit 3) after enrolment.
|
| Active Comparator: Control products FOF (6-12 months of age): 3 scoops in 140 ml water, 5-7 times/day YCF (1-1.5 years of age): 3 scoops in 130 ml water, 3 times/day |
Other: Control Formula
The duration of the study for each subject from enrolment to final visit, is 12 months. Control Formula will be provided during this 12 month.
After having signed for informed consent, screening of in- and exclusion criteria will be done. Subjects eligible for participation will be enrolled in the study and have their Visit 1 (enrolment / baseline visit). After visit 1, two more study visits will take place at six months (Visit 2) and twelve months (Visit 3) after enrolment.
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Outcome Measures
Primary Outcome Measures
- Body fat percentage [Every 6 months, up to 12 months]
Body fat percentage = (weight-FFM) / (weight*100), where FFM is Fat Free Mass
- Fat mass index [Every 6 months, up to 12 months]
Fat mass index = FM/length2, where FM is Fat Mass
- Fat free mass [Every 6 months, up to 12 months]
Fat free mass (kg)
- Fat mass [Every 6 months, up to 12 months]
Fat mass (kg)
Other Outcome Measures
- Weight [Every 6 months, up to 12 months]
weight, unit: kg
- Length [Every 6 months, up to 12 months]
length, unit: cm
- BMI [Every 6 months, up to 12 months]
BMI = weight/length2, unit: kg/cm2
- Stool sample characteristics [Every 6 months, up to 12 months]
Analysis of microbiome composition by using 16S rRNA sequencing or metagenomics or other omics technology
- Product intake [Every 6 months, up to 12 months]
Study product intake: number of bottles and amount consumed per bottle
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy, singleton, term born infants (gestational age ≥ 37 weeks + 0 days and ≤ 41 weeks + 6 days).
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Infants aged 6 months(± 2 weeks) at enrolment.
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Infants fed with formula (with or without additional weaning foods or drinks) before enrolment.
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Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at enrolment.
Exclusion Criteria:
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Infants who require a special diet other than FOF or YCF with intact cow's milk protein.
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Infants known or suspected to have cow's milk, fish protein, and/or soy allergy and/or lactose intolerance.
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Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
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Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.
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Incapability of infants' parents and/or legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements.
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Employees and/or infants/family members or relatives of employees of Danone Nutricia, the participating sites, or any other nutrition company that develops Infant, Follow On or Young Child formulae.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Danone Nutricia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NELN202110A