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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2022-10-13

Brief Summary

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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.

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Detailed Description

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Obesity and its cardiovascular consequences are the most important causes of morbidity and mortality worldwide. Breastfed infants have been shown to have less cardiovascular risk factors in adulthood, which can be partially explained by their slower growth compared to formula fed infants. 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 atherosclerotic cardiovascular disease (CVD), the critical windows for these programming effects, and the mechanisms of action.

Conditions

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Infant Formula Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

Modified infant formula

Intervention Type OTHER

Test formula with lower protein content than standard formula

Control Group

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

Group Type ACTIVE_COMPARATOR

Standard infant formula

Intervention Type OTHER

Standard infant formula

Breast-fed Reference Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Modified infant formula

Test formula with lower protein content than standard formula

Intervention Type OTHER

Standard infant formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)

Minimum Eligible Age

13 Weeks

Maximum Eligible Age

15 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes