Endothelial Function in Overweight Adult

Nutrients 2020 , 12 , 141

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subject number was 68. To account for drop outs and FMD assessment failures, in total 80 subjects were included. Descriptive characteristics are presented as mean ± SD. As the data were normally distributed (Kolmogorov–Smirnov test, p > 0.05), parametric tests were used. To compare the baseline characteristics of the isomaltulose ‐ first and sucrose ‐ first groups, unpaired t test for continuous variables and χ 2 test for categorical variables were applied. A mixed repeated ‐ measures analysis of variance (MMRM) with terms for treatment and period was performed to observe differences in endothelial responses following investigational products adjusted for baseline FMD. In this primary statistical analysis, only FMD data of those subjects with fully completed datasets of the four FMD measurements at visit 1 and the 4 FMD measurements at visit 2 were included. To compare differences in FMD, blood glucose, and insulin levels for the carbohydrates, an exploratory analysis at each of the time points within subjects between visits was performed using the paired t test. In these statistical analyses, subjects were included provided that both FMD measurements at a given time point were available. Pearson correlations were carried out to detect associations between FMD and blood glucose as well as insulin levels at different time points. For the evaluation of differences in the endothelial response depending on the insulin sensitivity status, subjects were classified according to their HOMA index on their first intervention day, and a subgroup analysis was performed. Subjects with HOMA < 2.5 were considered to be insulin ‐ sensitive (IS), whereas subjects with HOMA ≥ 2.5 were considered as insulin ‐ resistant (IR). To see differences in the change of FMD from baseline ( ∆ FMD Tx ‐ T0 ) between IS and IR subjects, unpaired t test was used. Two ‐ sided statistics was performed with the significance level set at p < 0.05.

3. Results

3.1. Descriptive Characteristics In total, 143 volunteers were screened for eligibility, of whom 80 were randomized, as all inclusion criteria were met. In total, 78 subjects completed the study, 39 for each randomization sequence. Two subjects dropped out due to anatomical difficulty in obtaining a proper FMD measurement at baseline. The baseline characteristics are presented in Table 1. Overall, age ranged from 28 to 60 years, and body mass index (BMI) from 24.8 to 34.9 kg/m². With regard to BMI, blood pressure, FMD, and blood glucose and insulin levels, sequence groups were comparable. In the isomaltulose ‐ first and sucrose ‐ first groups, 10 and 14 subjects (25% and 35%), respectively, were past smokers, without a statistically significant difference ( p = 0.33). None of the subjects had a high level of physical activity; 47 subjects (58.8%) had a moderate level and 33 (41.3%) a low level of physical activity. This was not different between the randomization sequences ( p = 0.26). Table 1. Baseline characteristics of the study population before the first intervention day (n = 78). 1,2 . Gender, % 34% Females, 66% Males Age, years 46.6 ± 8.4 Height, cm 174.4 ± 9.8 BMI, kg/m² 28.9 ± 2.6 Blood pressure (BP), mmHg Systolic BP 137.8 ± 5.0 Diastolic BP 88.2 ± 3.6 Fasting FMD, % 5.8 ± 2.5 Fasting blood glucose, mmol/L 4.9 ± 0.5 Fasting insulin, pmol/L 61.8 ± 28.0 HOMA index 1.9 ± 1.0 Insulin sensitivity 3 79% insulin sensitive, 21% insulin resistant

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