MedPath

The effect of the consumption of different wheat products on glucose kinetics and metabolic effects in healthy men - Part 2.

Completed
Conditions
EN: Insulin resistance/Type 2 diabetes mellitusNL: Insuline resistentie/Type 2 diabetes mellitus
Registration Number
NL-OMON21832
Lead Sponsor
Top Institute Food and Nutrition (TIFN)
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
10
Inclusion Criteria

1. Healthy male volunteer (at least 18 y old);

2. Used to eat breakfast (solid food);

Exclusion Criteria

1. BMI < 18 or > 25 kg/m2;

2. Not being able to fast overnight (12 hours);

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The main parameters of this study are postprandial plasma concentrations of glucose and insulin as well as the rate of appearance of exogenous glucose in plasma (glucose kinetics). Glucose kinetics is calculated using total plasma glucose concentration, the 13C/12C-ratio of glucose in plasma samples, and the 2H/1H-glucose ratio in plasma samples.
Secondary Outcome Measures
NameTimeMethod
The secondary study parameters are plasma concentrations of incretins. Metabolomic analysis will be performed in plasma and urine samples. In breath samples 13CO2 will be measured. In feces samples incorporation of 13C in intestinal microbes (after Low GI bread) will be determined. Sensation of appetite and satiety (VAS) after consumption of the test meal is also considered as a secondary parameter.<br /><br>Other study parameters include body weight, BMI, family history of T2DM, habitual diet, smoking habits, sportive activities, the liking of the test meal (VAS) as well as feeling and extent of discomfort after consumption of the test meal.
© Copyright 2025. All Rights Reserved by MedPath