N/A
Completed N=24
Metabolic Effect of High-protein Meals in Men
Healthy
Source: ClinicalTrials.gov NCT00712010 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Post-prandial Plasma Responses of Glucose Concentrations — 136.5; 121.2; 102.9; 160.3 mmole/L*min
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.
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 |
— | — |
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
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. Informational only — not medical advice.