Status:
COMPLETED
A Study to Investigate the Effect of Protein in Infant Formula on Insulin Response in Adults
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
To Compare the Metabolic Effects of Different Infant Milks
Eligibility:
All Genders
20-50 years
Phase:
NA
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 certa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04332510
Start Date
June 1 2012
End Date
June 1 2013
Last Update
April 2 2020
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