AzTrials
AzTrials

GrowthNCT07312201

Oral Nutritional Supplementation in Children With Growth Concerns

A study testing Nutrient dense oral nutritional supplement in people with Growth and Toddlers, run by Société des Produits Nestlé (SPN).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Multi-center, single-blinded, randomized, controlled study consisting of two arms, to investigate the impact of an oral nutritional supplement in combination with dietary counseling on growth in children with growth concerns as compared to children who receive dietary counselling alone Read more about this study

Who is it for?
Ages 24 to 41 monthsHealthy volunteers can take part
Conditions the study is for
Growth, Toddlers, Attention
What is being tested?
Nutrient dense oral nutritional supplement
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
No sites listed yet
Study dates
30 Sep 2026to 31 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 24 to 41 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Child's parent(s) is of legal age of majority (18 years of age), must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol.
  • Evidence of a personally signed and dated informed consent document indicating that the child's parent(s) / legally acceptable representative (LAR) has been informed of all pertinent aspects of the study.
  • Child was full-term at birth (i.e., ≥ 37 completed weeks of gestation with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg).
  • Child is aged 24 - 41 months at inclusion.
  • Child is generally healthy (acute illnesses in a minor condition which are common in childhood such as viral or bacterial infections (e.g., conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot \& mouth disease) at time of enrolment is permitted).
  • Children whose parents, caregivers, or guardians show some concern about their child's dietary intakes and growth, such as child is too thin for his or her height, or child has experienced recent rapid weight loss or failure to gain weight or height and child has a z-score for weight-for-age or weight-for-height or both parameters ≤ -1SD as per WHO growth charts.
  • Child's parents agree to feed their child an oral nutritional supplement in addition to normal diet.
  • Child's parent(s) / guardian can be contacted directly by telephone throughout the study.

Who cannot join

  • Child is currently breastfed or is consuming breast milk.
  • Child is currently consuming or consumed in the past month growing-up milk / toddler formula. Growing-up milks / toddler formulas are products specifically formulated for young children and provide key macro- and micro-nutrients.
  • Child is currently consuming or consumed in the past month oral nutrition supplement (ONS). The standard ONS formula has an energy density of at least 0.85 kcal/mL, containing protein, carbohydrate and/or fat, as well as a wide range of micronutrients to supplement or use as the sole source of nutrition.
  • Child has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, galactosemia, soy intolerance / allergy, fish oil intolerance / allergy, or allergy or intolerance to any ingredient in the study product.
  • Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded.
  • Underlying medical illness that could affect growth or feeding, such as gastrointestinal [GI] disorders (such as celiac disease, short bowel syndrome, maldigestion/malabsorption, significant GI malformations or surgery etc.); neurodevelopmental disability; chronic infections (such as tuberculosis or HIV infection); congenital disease or genetic disorders (such as congenital cardiac disease, Down syndrome, thalassemia); or other chronic illness that may impact growth or feeding according to the clinician opinion.
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  • Child is unable to consume foods or ONS orally (e.g. dysphagia, anorexia, difficulty in swallowing due to acquired or congenital abnormalities that would hamper oral intake of the study product.)
  • Clinically significant nutritional deficiency requiring specific nutritional therapy other than the study product (for example tube feeding)
  • Child has acute illness including acute viral infection, respiratory tract infection etc. even in a minor condition at time of enrolment. A child presenting with an acute illness can be re-screened at least two weeks after the episode of illness has resolved.
  • Child has a z-score for weight-for-height or weight-for-age or height-for-age or any combination of these three parameters ≤ -3SD as per WHO growth charts.
  • Children currently receiving or having received prior to enrolment medication which are known to impact growth including systemic steroids, growth hormone and insulin
  • Child or child's parent(s) not willing and/or not able to comply with scheduled visits and/or have plans to relocate to a different geographical location from the study location during the study period.
  • Child of any investigational site staff member or Nestlé employee directly involved in the conduct of the trial.
  • Child is currently participating in or has participated in another clinical trial within 4 weeks prior to enrolment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Renette Foo contact

+65 68905709

shufenrenette.foo@rd.nestle.com

Alison Petit-Jean contact

+41 216326193

alison.petit-jean@nestle.com

About this study

Official title: Oral Nutritional Supplementation in Children With Growth Concerns: A Randomized, Controlled Single-blinded Study

Multi-center, single-blinded, randomized, controlled study consisting of two arms, to investigate the impact of an oral nutritional supplement in combination with dietary counseling on growth in children with growth concerns as compared to children who receive dietary counselling alone

Being tested
Nutrient dense oral nutritional supplement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrient dense oral nutritional supplementDietary supplement

    The ONS is provided in powdered form that provides the appropriate amount of protein, vitamins and minerals

Study groups in NCT07312201
Study groupRoleWhat they receive
Experimental: Oral Nutritional Supplement (ONS) with Dietary CounsellingExperimentalThe ONS is a nutrient dense oral nutritional supplement provided in powdered form, coupled with dietary counselling conducted by a trained dietitian over a 24-week period.
Receives: Dietary Supplement: Nutrient dense oral nutritional supplement
Control: Dietary CounsellingNo interventionDietary counselling conducted by a trained dietitian over a 24-week period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the effect of ONS coupled with dietary counseling on growth in children

    Change in weight-for-age z score

    Measured: Day 1 to Day 169

Secondary outcomes (18)

  1. Weight of growing children

    Measurement of weight will be in grams

    Measured: Day -7 to Day 169

  2. Length/height of growing children

    Measurement of length/height will be in centimetres (cms)

    Measured: Day -7 to Day 169

  3. Mid-upper arm circumference of growing children

    Measurement of mid-upper arm circumference will be in centimetres (cms)

    Measured: Day -7 to Day 169

  4. Body mass index (BMI) of growing children

    Calculated BMI will be in kilograms per square metre (kg/m²)

    Measured: Day -7 to Day 169

  5. Z-scores and percentiles

    Change from baseline in sex-age-specific percentiles and z-scores

    Measured: Day -7 to Day 169

  6. Nutrient intake of children

    Paper-based 24-hour dietary recall administered by a trained dietitian on-site

    Measured: Day 1 to Day 169

  7. Bone mass index of children

    Bone density will be measured in z-scores

    Measured: Day 1 to Day 169

  8. Physical strength of children

    The grip strength will be measured in kilograms (kg)

    Measured: Day 1 to Day 169

  9. Skeletal muscle mass of children

    Urine sample will be collected in millimetres during the study (mL)

    Measured: Day 1 to Day 169

  10. Blood marker of longitudinal growth

    Blood sample will be collected during the study in microlitres (μL)

    Measured: Day 1 to Day 169

  11. Blood markers of bone turnover

    Blood sample will be collected during the study in microlitres (μL)

    Measured: Day 1 to Day 169

  12. Blood markers of nutritional status

    Blood sample will be collected during the study in microlitres (μL)

    Measured: Day 1 to Day 169

  13. Cognitive Functioning

    Questionnaire will be administered by the site staff for assessment

    Measured: Day 169

  14. Product satisfaction of children and parents

    Questionnaire will be administered by the site staff for assessment

    Measured: Day 14 to Day 169

  15. Parental perceptions on appetite, growth, level of activity and sleep of children

    Questionnaire will be administered by site staff for assessment

    Measured: Day 1 to Day 169

  16. Safety assessment (Adverse Events)

    Measured: Day -7 to Day 169

  17. Duration of illness and absence from pre-school due to illness

    Measured: Time Frame: Day -7 to Day 169

  18. Concomitant medications and treatments

    Measured: Day -7 to Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2025
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

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 N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07312201
Sponsor's protocol ID
2304INF
Status last verified
Dec 2025
First submitted
7 Jan 2025
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Nutrient dense oral nutritional supplement in people with Growth and Toddlers, run by Société des Produits Nestlé (SPN).

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 8 inclusion and 14 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: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Renette Foo (+65 68905709, shufenrenette.foo@rd.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the effect of ONS coupled with dietary counseling on growth in children (time frame: Day 1 to Day 169). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07312201.

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 31 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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