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

NCT04332510 | Completed

• 1 other identifier: 11.19.MET
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

To Compare the Metabolic Effects of Different Infant Milks

Keywords

infant formula; intact protein; partially-hydrolyzed protein; glucose; insulin; metabolic response

Outcome Measures

Primary Outcomes (1)

• 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

  0, 15, 30, 45, 60, 90, 120, 150, 180 mins

Study Arms (4)

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

Interventions

Intact formula OTHER

600 ml of infant formula with intact protein

Infant milk 1

Partially hydrolyzed formula OTHER

600 ml of infant formula with partially hydrolyzed protein

Infant milk 2

High protein formula OTHER

600 ml of infant formula with high protein level

Infant milk 3

Human breast milk OTHER

600 ml of breast milk, safe for human consumption

Infant milk 4

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Related Publications (1)

• 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.

  PMID: 33859173 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: \*\*Note: Human breast milk samples were not blinded for the care provider as they were supplied in different containers to the other milks.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 2, 2020
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 2, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share