Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease

NCT03456934 | Completed

• 1 other identifier: 15.09.INF
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.

Conditions

Infant Formula; Growth

Keywords

Protein requirements; Adiposity; Body composition; Cardiovascular health

Outcome Measures

Primary Outcomes (1)

• Infant weight gain

  Rate of weight gain (g/d)

  Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)

Secondary Outcomes (4)

• Body mass index (BMI)-for-age Z-score

  Age 2 years (+/- 1 month)

• Height-for-age Z-score

  Age 2 years (+/- 1 month)

• Adiposity

  Age 2 years (+/- 1 month)

• Fat mass

  Age 2 years (+/- 1 month)

Other Outcomes (15)

• Infant weight gain

  Between 6 and 12 months

• Weight

  Ages 4, 5, 6, 12 and 24 months

• Length or height

  Ages 4, 5, 6, 12 and 24 months

Study Arms (3)

Experimental Group

EXPERIMENTAL

Modified infant formula given from 3 to 12 months of age, as per standard requirement.

Other: Modified infant formula

Control Group

ACTIVE COMPARATOR

Standard infant formula given from 3 to 12 months of age, as per standard requirement.

Other: Standard infant formula

Breast-fed Reference Group

NO INTERVENTION

Non-randomized infants who are predominantly breast-fed at time of enrollment.

Interventions

Modified infant formula OTHER

Test formula with lower protein content than standard formula

Experimental Group

Standard infant formula OTHER

Standard infant formula

Control Group

Eligibility Criteria

• Age: 13 Weeks - 15 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy term infant
• Infant is aged 14 weeks (+/- 1 week)
• Infant is exclusively formula feeding or predominantly breast-feeding at age 14 weeks

You may not qualify if:

• Any adverse maternal, fetal or infant medical history that may have effects on growth and/or development
• Infant born with congenital disease or malformation affecting growth and/or development
• Food allergy to any trial products (e.g. milk, soy)

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• University College, London: collaborator

Study Sites (1)

UCL Institute of Child Health

London, WC1N 1EH, United Kingdom

Location

Related Publications (1)

• Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.

  PMID: 37929831 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Atul Singhal, MD

  Childhood Nutrition Research Centre, University College London, Institute of Child Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double-blind with nonrandomized breast-fed reference group

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 7, 2018
• Study Start: August 7, 2017
• Primary Completion: September 30, 2021
• Study Completion: October 13, 2022
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)