A Study to Investigate the Effect of Protein in Infant Formula on Insulin Response in Adults (IDEFIX)
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
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
600 ml of infant formula with intact protein
|
|
Experimental: Infant milk 2
|
600 ml of infant formula with partially hydrolyzed protein
|
|
Experimental: Infant milk 3
|
600 ml of infant formula with high protein level
|
|
Experimental: Infant milk 4
|
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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