A Study to Investigate the Effect of Protein in Infant Formula on Insulin Response in Adults

It has been established that the consumption of a diet that causes a low rise in blood insulin levels is beneficial in terms of risk for diabetes and heart disease. Furthermore, it is known that certain nutrients contained within a food play an important role in the insulin response of that food. For example, the type and quantity of protein has been shown to affect the insulin response to particular foods.

Different types of infant formula exist, containing different levels and types of protein, yet the impact of these different infant formulas on blood insulin levels is not known.

Using a randomized, double blind, cross-over study design, the insulin response to four test milks was compared in healthy adults. The four test milks were as follows: i) infant formula containing partially hydrolyzed protein; ii) infant formula with intact protein; (iii) infant formula with a higher energy and protein content compared to (i) and (ii); and (iv) human breast milk (in a small sub-group). The aim of the study was to show that the insulin response to the partially hydrolyzed formula is similar to that of an infant formula with intact protein.

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Key information

Conditions

To Compare the Metabolic Effects of Different Infant Milks Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy males and females aged 20-50 years at time of the enrollment
Normal body weight. BMI 19-25 kg/m2
Having obtained his/her signed informed consent

Exclusion criteria

Chronic or acute diseases affecting metabolism (diabetes, renal insufficiency, CVD, liver disease), dyslipidemia, as checked using the medical questionnaire and based on a biochemical blood analysis (glucose, triglycerides, cholesterol, transaminases and Gamma-GT, CRP in fasting

Anemia (Erythrocytes < 4,6 T/l (male) or < 4,2 T/l (women); Hemoglobin Hb < 13 g/dl (male) or Hb < 12 g/dl (women); Hematocrit Ht < 40% (male) or Ht < 37% (women); sera iron < 0,6 mg/l or plasma ferritin < 120 μg /l (male) or < 60 μg/l (non menopaused women)
Recent major surgery (3 months)
History of cancer within the past year
Significant weight loss during the last 3 months (more than 5% of BW)
Regular intensive physical activity of more than 3 times of 45 min per week
Food allergy, lactose intolerance
Under chronic medications (except contraceptive pills) Have a regular higher alcohol consumption than 1 drink/day or occasional 1-2 drinks during week end
Consumption of illicit drugs, as checked by a urinary testing
Smoking (more than 5 cigarettes a day)
Women pregnant or lactating
Special weight reduction program /diet
Blood donation of at least 300mL during the last 3 months or planned blood donation before the end of the study
Subject who cannot be expected to comply with the study procedures, including consuming the test products (600 mL of milk within 10 minutes)
Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Treatment and study plan

Intact formula

Other

600 ml of infant formula with intact protein

partially hydrolyzed formula

Other

600 ml of infant formula with partially hydrolyzed protein

High protein formula

Other

600 ml of infant formula with high protein level

Human breast milk

Other

600 ml of breast milk, safe for human consumption

Primary outcomes

Insulin response to infant formulas containing partially hydrolyzed or intact protein

Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180 mins

To show that the insulin Cmax response to a partially hydrolyzed formula is similar to that of an infant formula with intact protein

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Acute Metabolic Effect of Different Infant Formulas (Intact Protein, Partially Hydrolyzed Protein and High Level of Partially Hydrolyzed Protein) and Breast Milk in Healthy Adults

Acronym: IDEFIX

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Apr 2, 2020
Registry last updated: Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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