Picky Eating BehaviorsPhase 4NCT01823302
Effect of a New Growing-up Milk on Growth and Nutrient Adequacy in Children With Picky-eating Behaviors
A Phase 4 study testing nutrition counseling plus oral milk-based nutritional supplement and nutritional counseling in people with Picky Eating Behaviors, run by Société des Produits Nestlé (SPN) at 2 sites in China.
Trial summary
The primary objective of the study was to compare the change in z-scores for growth during a 120-day study period in children with picky eating behaviors who were randomly assigned to receive nutrition counseling only (control group) or nutrition counseling plus an oral milk-based nutritional supplement (study group). Read more about this study
- Who is it for?
- Ages 30 to 60 months
- Conditions the study is for
- Picky Eating Behaviors
- What is being tested?
- nutrition counseling plus oral milk-based nutritional supplement and nutritional counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 2 sitesChina
- Study dates
- Feb 2010to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 30-60 months with PE behavior as reported by caregivers and whose weight-for-height was ≤25th percentile according to World Health Organization (WHO) Child Growth Standards were eligible for inclusion.
Who cannot join
- Current acute or chronic illness, food allergies, lactose intolerance, dietary restrictions precluding dairy foods, any genetic disorder that may compromise growth and/or food intake, cognitive or developmental disorders, or medications that may influence study outcomes.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Xinhua Hospital Affiliated to Shanghai Jiaotong
Shanghai, Shanghai Municipality, 200092
About this study
The primary objective of the study was to compare the change in z-scores for growth during a 120-day study period in children with picky eating behaviors who were randomly assigned to receive nutrition counseling only (control group) or nutrition counseling plus an oral milk-based nutritional supplement (study group). The secondary objectives of the study were to compare the following between the control and study groups: a) dietary macro- and micro-nutrient intakes; b) quantitative ultrasound bone measurements of radius and tibia; and c) incidence of common illnesses (diarrhea, upper and lower respiratory tract). The safety objective of the study was to compare the frequency of adverse events (AE) among the control group and study group subjects.
- Conditions
- Picky Eating Behaviors
- Being tested
- nutrition counseling plus oral milk-based nutritional supplement, nutritional counseling
- Keywords
- Children with picky-eating behaviors, Children aged 2.5 - 5 years, reported by caregivers, with weight-for-height z-scores ≤ 25th percentile at enrollment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition counseling plus oral milk-based nutritional supplementDietary supplement
Study group subjects were instructed to consume at least 2 servings (230 mL per serving) of an oral milk-based nutritional supplement daily, in addition to their regular diet, for a total of 120 (±3) days.
nutritional counselingOther
nutritional counseling
| Study group | Role | What they receive |
|---|---|---|
| nutritional counseling | Other | nutritional counseling Receives: Other: nutritional counseling |
| nutritional counseling and milk-based supplement | Other | nutritional counseling plus oral milk-based nutrition supplement Receives: Dietary Supplement: nutrition counseling plus oral milk-based nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors
The primary efficacy evaluation was growth, including the change in weight-for-height z-score from baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.
Measured: baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.
Secondary outcomes (1)
Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors
Secondary efficacy evaluations included: dietary macro- and micro-nutrient intakes, quantitative ultrasound measurements of the radius and tibia, and incidence of common illnesses (diarrhea, and upper and lower respiratory tract infection).
Measured: baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Picky Eating BehaviorsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoyang Sheng, Professor, Principal investigator, Xinhua Hospital Affiliated to Shanghai Jiaotong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823302
- Sponsor's protocol ID
- 9601A1-4000
- Status last verified
- Mar 2013
- First submitted
- 21 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a New Growing-up Milk on Growth and Nutrient Adequacy in Children With Picky-eating Behaviors
- ClinicalTrials.gov ID
- NCT01823302
- Acronym / sponsor ID
- 9601A1-4000
- Conditions
- Picky Eating Behaviors
- Keywords
- Children with picky-eating behaviors, Children aged 2.5 - 5 years, reported by caregivers, with weight-for-height z-scores ≤ 25th percentile at enrollment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to compare the change in z-scores for growth during a 120-day study period in children with picky eating behaviors who were randomly assigned to receive nutrition counseling only (control group) or nutrition counseling plus an oral milk-based nutritional supplement (study group). The secondary objectives of the study were to compare the following between the control and study groups: a) dietary macro- and micro-nutrient intakes; b) quantitative ultrasound bone measurements of radius and tibia; and c) incidence of common illnesses (diarrhea, upper and lower respiratory tract). The safety objective of the study was to compare the frequency of adverse events (AE) among the control group and study group subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutritional counseling | Other | Other: nutritional counselingnutritional counseling |
| nutritional counseling and milk-based supplement | Other | Dietary Supplement: nutrition counseling plus oral milk-based nutritional supplementnutritional counseling plus oral milk-based nutrition supplement |
Who may qualify
- Ages
- 30 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 30-60 months with PE behavior as reported by caregivers and whose weight-for-height was ≤25th percentile according to World Health Organization (WHO) Child Growth Standards were eligible for inclusion.
Key exclusion criteria (1 listed)
- Current acute or chronic illness, food allergies, lactose intolerance, dietary restrictions precluding dairy foods, any genetic disorder that may compromise growth and/or food intake, cognitive or developmental disorders, or medications that may influence study outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrition counseling plus oral milk-based nutritional supplementStudy group subjects were instructed to consume at least 2 servings (230 mL per serving) of an oral milk-based nutritional supplement daily, in addition to their regular diet, for a total of 120 (±3) days. | Dietary supplement | nutritional counseling and milk-based supplement |
| nutritional counselingnutritional counseling | Other | nutritional counseling |
Primary outcome
Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors
Time frame: baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.
The primary efficacy evaluation was growth, including the change in weight-for-height z-score from baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.
1 secondary outcome
Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors
Time frame: baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyang Sheng, Professor principal investigator
Xinhua Hospital Affiliated to Shanghai Jiaotong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nutrition counseling plus oral milk-based nutritional supplement and nutritional counseling in people with Picky Eating Behaviors, run by Société des Produits Nestlé (SPN) at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors (time frame: baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.