Effect of Nutritional Intervention on Metabolic Response in Infants

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04483453
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.3
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Infant Development; Glucose, High Blood	Other: EXPL feeding regimen; Other: CTRL feeding regimen	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Effect of Nutritional Intervention on Metabolic Response in Infants: A Single-Blind, Randomized, Controlled Trial
• Actual Study Start Date: Jul 31, 2020
• Actual Primary Completion Date: Apr 29, 2021
• Actual Study Completion Date: Jun 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EXPL feeding regimen Lower protein / lower estimated glycemic index regimen	Other: EXPL feeding regimen; EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)
Active Comparator: CTRL feeding regimen Standard protein / standard glycemic index regimen	Other: CTRL feeding regimen; CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)

Outcome Measures

Primary Outcome Measures

1. Glucose peak [Study days 85-92]

   Average of the glucose peaks measured by a continuous glucose monitor

Secondary Outcome Measures

1. Glycemic response [Study days 85-92]

   Incremental area under the blood glucose response curve

2. Glucose response variability [Study days 85-92]

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

3. Skinfold thickness [age 6 months, 9 months, and 12 months]

   Subscapular and triceps skinfold thicknesses

4. Weight [age 6 months, 9 months, and 12 months]

   Weight (g)

5. Length [age 6 months, 9 months, and 12 months]

   Length (cm)

6. Head circumference [age 6 months, 9 months, and 12 months]

   Head circumference (cm)

7. Body mass index (BMI) [age 6 months, 9 months, and 12 months]

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

8. Weight-for-age z-score [age 6 months, 9 months, and 12 months]

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

9. Weight-for-length z-score [age 6 months, 9 months, and 12 months]

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

10. Length-for-age z-score [age 6 months, 9 months, and 12 months]

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

11. Head circumference-for-age z-score [age 6 months, 9 months, and 12 months]

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

12. BMI-for-age z-score [age 6 months, 9 months, and 12 months]

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

13. Insulin secretion [age 6 months, 9 months, and 12 months]

    Urinary C-peptide:creatinine ratio

14. Dietary intake [age 6 months, 9 months, and 12 months]

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

15. Stool microbiota composition [age 6 months, 7.5 months, 9 months, and 12 months]

    Fecal microbiota composition assessed using next generation sequencing

16. Stool pH [age 6 months, 7.5 months, 9 months, and 12 months]

    Stool pH

17. Stool microbiota metabolism [age 6 months, 7.5 months, 9 months, and 12 months]

    Stool organic acids

18. Gastrointestinal (GI) tolerance [age 6 months, 9 months, and 12 months]

    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.

19. Health-related quality of life [age 6 months, 9 months, and 12 months]

    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.

Other Outcome Measures

1. Insulin-like growth factor-1 (IGF-1) [age 6 months, 9 months, and 12 months]

   Urinary IGF-1

2. Urinary metabolomic profile [age 6 months, 9 months, and 12 months]

   Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Weeks to 26 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:.

1. Written informed consent has been obtained from both parent / liable parent or legally acceptable representative (LAR), if applicable

2. 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

3. Infant is no longer breastfeeding or receiving breast milk, has not yet started FUF, and is developmentally ready to begin complementary feeding

4. 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.

5. At screening visit (visit 0), infant is 24 - 26 weeks (5½ - 6 months) old

6. Weight-for-height value >-2 standard deviations from the WHO Child Growth Standards median

Exclusion Criteria:

1. 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

2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)

3. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, gluten sensitivity or severe food allergies that impact diet

4. Born to mothers with gestational diabetes or type 1 diabetes

5. Major medical/surgical event requiring prolonged hospitalization during the first 6 months

6. 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

7. 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

8. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Las Piñas Doctors Hospital	Las Piñas		Philippines	1742

Sponsors and Collaborators

• Nestlé

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT04483453
• Other Study ID Numbers: 18.17.INF
• First Posted: Jul 23, 2020
• Last Update Posted: Oct 5, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 5, 2021