Oral Nutritional Supplementation in Children With Growth Concerns

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

Study Overview

• Status: Not yet recruiting
• Conditions: Growth; Cognitive Function; Attention; Toddlers
• Intervention / Treatment: Dietary supplement: Nutrient dense oral nutritional supplement

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renette Foo; Phone Number: +65 68905709; Email: shufenrenette.foo@rd.nestle.com
• Study Contact Backup: Name: Alison Petit-Jean; Phone Number: +41 216326193; Email: alison.petit-jean@nestle.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Oral Nutritional Supplement (ONS) with Dietary Counselling; The 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.	Dietary supplement: Nutrient dense oral nutritional supplement; The ONS is provided in powdered form that provides the appropriate amount of protein, vitamins and minerals
No Intervention: Control: Dietary Counselling; Dietary counselling conducted by a trained dietitian over a 24-week period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the effect of ONS coupled with dietary counseling on growth in children	Change in weight-for-age z score	Day 1 to Day 169

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight of growing children	Measurement of weight will be in grams	Day -7 to Day 169
Length/height of growing children	Measurement of length/height will be in centimetres (cms)	Day -7 to Day 169
Mid-upper arm circumference of growing children	Measurement of mid-upper arm circumference will be in centimetres (cms)	Day -7 to Day 169
Body mass index (BMI) of growing children	Calculated BMI will be in kilograms per square metre (kg/m²)	Day -7 to Day 169
Z-scores and percentiles	Change from baseline in sex-age-specific percentiles and z-scores	Day -7 to Day 169
Nutrient intake of children	Paper-based 24-hour dietary recall administered by a trained dietitian on-site	Day 1 to Day 169
Bone mass index of children	Bone density will be measured in z-scores	Day 1 to Day 169
Physical strength of children	The grip strength will be measured in kilograms (kg)	Day 1 to Day 169
Skeletal muscle mass of children	Urine sample will be collected in millimetres during the study (mL)	Day 1 to Day 169
Blood marker of longitudinal growth	Blood sample will be collected during the study in microlitres (μL)	Day 1 to Day 169
Blood markers of bone turnover	Blood sample will be collected during the study in microlitres (μL)	Day 1 to Day 169
Blood markers of nutritional status	Blood sample will be collected during the study in microlitres (μL)	Day 1 to Day 169
Cognitive Functioning	Questionnaire will be administered by the site staff for assessment	Day 169
Product satisfaction of children and parents	Questionnaire will be administered by the site staff for assessment	Day 14 to Day 169
Parental perceptions on appetite, growth, level of activity and sleep of children	Questionnaire will be administered by site staff for assessment	Day 1 to Day 169
Safety assessment (Adverse Events)		Day -7 to Day 169
Duration of illness and absence from pre-school due to illness		Time Frame: Day -7 to Day 169
Concomitant medications and treatments		Day -7 to Day 169

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2304INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No