NCT04483453

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

July 31, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

July 6, 2020

Last Update Submit

October 4, 2021

Conditions

Infant DevelopmentGlucose, High Blood

Outcome Measures

Primary Outcomes (1)

  • Glucose peak

    Average of the glucose peaks measured by a continuous glucose monitor

    Study days 85-92

Secondary Outcomes (19)

  • Glycemic response

    Study days 85-92

  • Glucose response variability

    Study days 85-92

  • Skinfold thickness

    age 6 months, 9 months, and 12 months

  • Weight

    age 6 months, 9 months, and 12 months

  • Length

    age 6 months, 9 months, and 12 months

  • +14 more secondary outcomes

Other Outcomes (2)

  • Insulin-like growth factor-1 (IGF-1)

    age 6 months, 9 months, and 12 months

  • Urinary metabolomic profile

    age 6 months, 9 months, and 12 months

Study Arms (2)

EXPL feeding regimen

EXPERIMENTAL

Lower protein / lower estimated glycemic index regimen

Other: EXPL feeding regimen

CTRL feeding regimen

ACTIVE COMPARATOR

Standard protein / standard glycemic index regimen

Other: CTRL feeding regimen

Interventions

EXPL feeding regimenOTHER

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

EXPL feeding regimen
CTRL feeding regimenOTHER

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

CTRL feeding regimen

Eligibility Criteria

Age24 Weeks - 26 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Las Piñas Doctors Hospital

Las Piñas, 1742, Philippines

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 23, 2020

Study Start

July 31, 2020

Primary Completion

April 29, 2021

Study Completion

June 9, 2021

Last Updated

October 5, 2021

Record last verified: 2021-10

Locations

PH(1)