AzTrials
AzTrials

Infant DevelopmentNCT04483453

Effect of Nutritional Intervention on Metabolic Response in Infants

A study testing EXPL feeding regimen and CTRL feeding regimen in people with Infant Development and Glucose, High Blood, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the glucose response of complementary feeding regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs). Read more about this study

Who is it for?
Ages 24 to 26 weeksHealthy volunteers can take part
Conditions the study is for
Infant Development, Glucose, High Blood
What is being tested?
EXPL feeding regimen and CTRL feeding regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 sitePhilippines
Study dates
31 Jul 2020to 9 Jun 2021
Phase
Interventional
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 24 to 26 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Written informed consent has been obtained from both parent / liable parent or legally acceptable representative (LAR), if applicable
  • Healthy infant who was singleton, full-term gestational birth (≥ 37 completed weeks of gestation) with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg
  • Infant is no longer breastfeeding or receiving breast milk, has not yet started FUF, and is developmentally ready to begin complementary feeding
  • Infant's parent(s)/guardian is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.
  • At screening visit (visit 0), infant is 24 - 26 weeks (5½ - 6 months) old
  • Weight-for-height value >-2 standard deviations from the WHO Child Growth Standards median

Who cannot join

  • Chronic infectious, metabolic, or other disease including any condition that in the opinion of the investigator may impact feeding, growth or adherence to study procedures
  • Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
  • Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, gluten sensitivity or severe food allergies that impact diet
  • Born to mothers with gestational diabetes or type 1 diabetes
  • Major medical/surgical event requiring prolonged hospitalization during the first 6 months
  • Receiving or having received insulin, growth hormone or any other medication known to affect glucose or carbohydrate metabolism or pre- or probiotics known to affect fecal microbiota prior to enrollment
  • Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol
  • Currently participating or having participated in another clinical trial within 4 weeks prior to trial start

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • Las Piñas Doctors Hospital

    Las Piñas, 1742

Other trials in Philippines

About this study

Official title: Effect of Nutritional Intervention on Metabolic Response in Infants: A Single-Blind, Randomized, Controlled Trial

The purpose of this study is to determine the glucose response of complementary feeding regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs).

Read the detailed description

This is a prospective, randomized, single-blind, controlled, 2-arm parallel group trial in infants aged 6 months (26 weeks) at enrollment, who are no longer breastfed, and who are ready but have not yet started complementary feeding. They will be fed one of two different isocaloric feeding regimens (Experimental [EXPL] or Control [CTRL]) consisting of different follow-up formulas (FUFs) and infant cereals (ICs). The main purpose of this study is to determine the glucose response of these two different complementary feeding regimens. All enrolled infants will participate in the trial for approximately 6 months.

Being tested
EXPL feeding regimen, CTRL feeding regimen

What participants receive

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

  • EXPL feeding regimenOther

    EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)

  • CTRL feeding regimenOther

    CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)

Study groups in NCT04483453
Study groupRoleWhat they receive
EXPL feeding regimenExperimentalLower protein / lower estimated glycemic index regimen
Receives: Other: EXPL feeding regimen
CTRL feeding regimenActive comparatorStandard protein / standard glycemic index regimen
Receives: Other: CTRL feeding regimen

What is being measured

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

  1. Glucose peak

    Average of the glucose peaks measured by a continuous glucose monitor

    Measured: Study days 85-92

Secondary outcomes (19)

  1. Glycemic response

    Incremental area under the blood glucose response curve

    Measured: Study days 85-92

  2. Glucose response variability

    Mean amplitude of glycemic excursions, standard deviation, J-index

    Measured: Study days 85-92

  3. Skinfold thickness

    Subscapular and triceps skinfold thicknesses

    Measured: age 6 months, 9 months, and 12 months

  4. Weight

    Weight (g)

    Measured: age 6 months, 9 months, and 12 months

  5. Length

    Length (cm)

    Measured: age 6 months, 9 months, and 12 months

  6. Head circumference

    Head circumference (cm)

    Measured: age 6 months, 9 months, and 12 months

  7. Body mass index (BMI)

    Weight and height will be combined to report BMI in kg/m^2

    Measured: age 6 months, 9 months, and 12 months

  8. Weight-for-age z-score

    Weight-for-age z-score based on World Health Organization (WHO) growth charts

    Measured: age 6 months, 9 months, and 12 months

  9. Weight-for-length z-score

    Weight-for-length z-score based on WHO growth charts

    Measured: age 6 months, 9 months, and 12 months

  10. Length-for-age z-score

    Length-for-age z-score based on WHO growth charts

    Measured: age 6 months, 9 months, and 12 months

  11. Head circumference-for-age z-score

    Head circumference-for-age z-score based on WHO growth charts

    Measured: age 6 months, 9 months, and 12 months

  12. BMI-for-age z-score

    BMI-for-age z-score based on WHO growth charts

    Measured: age 6 months, 9 months, and 12 months

  13. Insulin secretion

    Urinary C-peptide:creatinine ratio

    Measured: age 6 months, 9 months, and 12 months

  14. Dietary intake

    Total energy, carbohydrate and protein intake calculated from food recalls / diaries

    Measured: age 6 months, 9 months, and 12 months

  15. Stool microbiota composition

    Fecal microbiota composition assessed using next generation sequencing

    Measured: age 6 months, 7.5 months, 9 months, and 12 months

  16. Stool pH

    Stool pH

    Measured: age 6 months, 7.5 months, 9 months, and 12 months

  17. Stool microbiota metabolism

    Stool organic acids

    Measured: age 6 months, 7.5 months, 9 months, and 12 months

  18. Gastrointestinal (GI) tolerance

    GI tolerance assessed using the Infant Gastrointestinal Symptom Questionnaire (IGSQ). IGSQ scores range from 13 to 65, with lower scores indicating lower GI symptom burden.

    Measured: age 6 months, 9 months, and 12 months

  19. Health-related quality of life

    Health-related quality of life using the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47). ITQOL-SF47 scores range from 0 to 100, with higher scores indicating a more favorable health-related quality of life.

    Measured: age 6 months, 9 months, and 12 months

Timeline

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

  1. First posted23 Jul 2020
  2. Study start31 Jul 2020
  3. Primary completion29 Apr 2021
  4. Study completion9 Jun 2021

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
Investigator
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04483453
Sponsor's protocol ID
18.17.INF
Status last verified
Oct 2021
First submitted
6 Jul 2020
Last updated
5 Oct 2021
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 EXPL feeding regimen and CTRL feeding regimen in people with Infant Development and Glucose, High Blood, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.

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 6 inclusion and 8 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. 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.

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?

Glucose peak (time frame: Study days 85-92). 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 NCT04483453.

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 5 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in