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

April 1, 2020 updated by: Société des Produits Nestlé (SPN)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infant milk 1
Other: Intact formula
600 ml of infant formula with intact protein
Experimental: Infant milk 2
Other: Partially hydrolyzed formula
600 ml of infant formula with partially hydrolyzed protein
Experimental: Infant milk 3
Other: High protein formula
600 ml of infant formula with high protein level
Experimental: Infant milk 4
Other: Human breast milk
600 ml of breast milk, safe for human consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0, 15, 30, 45, 60, 90, 120, 150, 180 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 2, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11.19.MET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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