To Compare the Metabolic Effects of Different Infant MilksIDEFIXNCT04332510
A Study to Investigate the Effect of Protein in Infant Formula on Insulin Response in Adults
A study testing Intact formula, Partially hydrolyzed formula and High protein formula in people with To Compare the Metabolic Effects of Different Infant Milks, run by Société des Produits Nestlé (SPN).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- To Compare the Metabolic Effects of Different Infant Milks
- What is being tested?
- Intact formula, Partially hydrolyzed formula and High protein formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
Official 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
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.
- Being tested
- Intact formula, Partially hydrolyzed formula, High protein formula, Human breast milk
- Keywords
- infant formula, intact protein, partially-hydrolyzed protein, glucose, insulin, metabolic response
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intact formulaOther
600 ml of infant formula with intact protein
Partially hydrolyzed formulaOther
600 ml of infant formula with partially hydrolyzed protein
High protein formulaOther
600 ml of infant formula with high protein level
Human breast milkOther
600 ml of breast milk, safe for human consumption
| Study group | Role | What they receive |
|---|---|---|
| Infant milk 1 | Experimental | Not described Receives: Other: Intact formula |
| Infant milk 2 | Experimental | Not described Receives: Other: Partially hydrolyzed formula |
| Infant milk 3 | Experimental | Not described Receives: Other: High protein formula |
| Infant milk 4 | Experimental | Not described Receives: Other: Human breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin response to infant formulas containing partially hydrolyzed or intact protein
To show that the insulin Cmax response to a partially hydrolyzed formula is similar to that of an infant formula with intact protein
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Compare the Metabolic Effects of Different Infant MilksStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332510
- Sponsor's protocol ID
- 11.19.MET
- Acronym
- IDEFIX
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shahkhalili Y, Monnard C, Grathwohl D, Sauser J, Beaumont M, Zufferey CA, Mace K. Comparison of the acute metabolic effect of different infant formulas and human milk in healthy adults: a randomized trial. Nutr Diabetes. 2021 Apr 15;11(1):13. doi: 10.1038/s41387-021-00154-3.
PubMed 33859173
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04332510
- Acronym / sponsor ID
- IDEFIX / 11.19.MET
- Keywords
- infant formula, intact protein, partially-hydrolyzed protein, glucose, insulin, metabolic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Infant milk 1 | Experimental | Other: Intact formula |
| Infant milk 2 | Experimental | Other: Partially hydrolyzed formula |
| Infant milk 3 | Experimental | Other: High protein formula |
| Infant milk 4 | Experimental | Other: Human breast milk |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intact formula600 ml of infant formula with intact protein | Other | Infant milk 1 |
| Partially hydrolyzed formula600 ml of infant formula with partially hydrolyzed protein | Other | Infant milk 2 |
| High protein formula600 ml of infant formula with high protein level | Other | Infant milk 3 |
| Human breast milk600 ml of breast milk, safe for human consumption | Other | Infant milk 4 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Derived from this study: PubMed 33859173Shahkhalili Y, Monnard C, Grathwohl D, Sauser J, Beaumont M, Zufferey CA, Mace K. Comparison of the acute metabolic effect of different infant formulas and human milk in healthy adults: a randomized trial. Nutr Diabetes. 2021 Apr 15;11(1):13. doi: 10.1038/s41387-021-00154-3.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intact formula, Partially hydrolyzed formula and High protein formula in people with To Compare the Metabolic Effects of Different Infant Milks, run by Société des Produits Nestlé (SPN).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin response to infant formulas containing partially hydrolyzed or intact protein (time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.