N/A N=24 Randomized Quadruple-blind Basic Science

Metabolic Effect of High-protein Meals in Men

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT00712010 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2013

Primary outcome: Primary: Post-prandial Plasma Responses of Glucose Concentrations — 136.5; 121.2; 102.9; 160.3 mmole/L*min

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Whey protein native (Other); Whey protein microgels (Other); Hydrolyzed whey protein (Other); Casein native (Other); Hydrolyzed casein (Other); Total milk protein native (Other); Hydrolyzed milk protein (Other)
Age: Adult · 20+ yrs
Sex: Male
Sponsor: Société des Produits Nestlé (SPN)
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Post-prandial Plasma Responses of Glucose Concentrations	136.5; 121.2; 102.9; 160.3; 88.7; 117.7	—
PRIMARY Calculation of the Area Under Curve Over Baseline for Plasma Insulin	34,428; 28,756; 32,319; 27,082; 34,847; 26,476	—
SECONDARY Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids	—	—

Summary

The purpose of the clinical study is to investigate the effect of the protein quality of high-protein meal replacements on the management of post-prandial blood glucose in healthy men.

Eligibility Criteria

Inclusion Criteria

20 - 50 years, male
Healthy as determined by a medical questionnaire
Normal weight: BMI 20 - 24.9 kg.m-2
Normal fasting glycemia and insulinemia
Normal fasting lipidemia (cholesterol and triglycerides)
Normal liver function (transaminases, γ-GT) and kidney function (urea, creatinine)
Capable of fast ingestion of the meal replacement (5-10 min)
Having signed informed consent

Exclusion Criteria

Intestinal or metabolic diseases/disorders such as diabetic, renal, dyslipidemia, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance.
Hypertension >150/95 mmHg
Have had a gastrointestinal surgery
Have a regular consumption of medication
Vegetarian, vegan, under dietary supplements
Have an alcohol intake: > 2 units a day or smoker
Currently participating or having participated in a clinical trial during the last month
Having given blood in the last month
More than 5 x 45 min of intense exercise per week
Volunteer who cannot be expected to comply with treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00712010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.