An Evaluation of the Tolerability and Acceptability of a New Plant-based Formula for Young Children

NCT ID: NCT05265156

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2022-04-14

Brief Summary

An evaluation of the tolerability and acceptability of a new plant-based formula in 45 healthy young children

Detailed Description

The aim of this study is to evaluate the tolerability and acceptability of a new plant-based formula for young children. The study population consists of 45 healthy children of ≥12 and <36 months of age

Conditions

Healthy Young Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Plant based formula for young children

The study is designed with a single arm, so all subjects will receive the study product.

Group Type: OTHER

Plant based formula for children aged between 12 and 36 months

Intervention Type: OTHER

Daily intake of plant based formula for 3 weeks (400ml-600ml per day).

Interventions

Plant based formula for children aged between 12 and 36 months

Daily intake of plant based formula for 3 weeks (400ml-600ml per day).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy male and female children as per the clinical judgement of the Investigator

2. Singleton children

3. Children ≥12 and <36 months of age at screening

4. Children who have been drinking dairy based beverages or plant-based milk replacements (in combination with breastfeeding or not) for at least 3 weeks prior to screening

5. Children are familiar with drinking ≥400 ml/day of dairy based beverages or plant-based milk replacements,

6. Written informed consent from the parent(s) and/or legal guardian(s) (≥ 18 years of age)

Exclusion Criteria

1. Children with medical conditions requiring a special diet such as fibre-free diet, food allergy, or food intolerances

2. Children with current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters (e.g. diarrhoea requiring treatment, constipation requiring treatment, regurgitation requiring treatment, dental/medical procedures which may impact oral feeding), as per the clinical judgment of the Investigator, within 3 weeks prior to screening

3. Use of medication or nutritional/food supplements known to impact GI tolerance (e.g. anti-regurgitation (including any thickening agent), anti-reflux, anti-diarrheal, laxative medication, systemic antibiotic, probiotic supplements) within 3 weeks prior to screening

4. Children who are using diapers

5. Siblings of participating children

6. Participation in any other study involving investigational or marketed products concomitantly or within 3 weeks prior to screening

7. Children of employees and/or family members or relatives of employees of Danone Nutricia Indonesia or of the participating research institute and local community facilities

8. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol instructions, including daily completion of the diaries by the parents.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitas Gadjah Mada

Yogyakarta, , Indonesia

Countries

Indonesia

Other Identifiers

SBB20R&31559

Identifier Type: -

Identifier Source: org_study_id