Foods 2020 , 9 , 1147
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Table 2. Summary of main readouts from Trial NCT04450979 and associated significance of e ff ects measured.
Readout
Measured By
E ff ect None
p Value
Gut Discomfort
Questionnaire
NS
TNF- α
ELISA
0.03 *
↓ ↑ ↓ ↑ ↑ ↑
HDL LDL
Blood Chem Panel Blood Chem Panel
< 0.001 ** < 0.001 ** < 0.001 #
Oral Glucose Tolerance Test
Glucometer Physical Test Physical Test Physical Test
Chair Stand HandGrip
0.02
None
NS
SPPB 0.04 * Overall area under the curve (AUC) across the entire study reported; ** Values were associated with compliance; # GEE analysis showed that the reduction during the whole test interval (0–120 min) with respect to the di ff erence in AUC at baseline and week 12 was significant ( p < 0.001). In order to assess the e ff ect of supplementation with the rice NPN, upper and lower body strength were measured by the hand grip test and chair stand tests respectively, at 0, 4, 8, and 12 weeks, while a short physical performance battery was performed at weeks 0 and 12. Performance of the treatment group (rice NPN) in the repeated chair stand test was significantly ( p = 0.02) improved compared to that of the placebo group, with participants in the treatment group consistently completing chair stands in less time than those in the placebo group (Figure 4a). Two key confounding factors in this dataset were compliance and the time at which the study was measured, i.e., the end of the trial period overlapped with the Christmas period. As such, compliance was possibly not as strict during this period. However, the e ff ect was still observed. When a subgroup analysis was performed, the change observed in the chair test performance was associated with start value at baseline ( p < 0.001), the higher the start value the larger the overall decrease in repeated chair test time at later intervals in both groups ( p < 0.001). It was also observed that age inversely correlated with decrease, the older the subject, the lower the decrease ( p < 0.001). In the Short Physical Performance Battery Test, a significant di ff erence was reported between the physical performance of the treatment group compared to the placebo ( p = 0.04), with higher scores attained for the treatment group (Figure 4b). A subgroup analysis showed that age ( p < 0.001); the older the subject, the lower the increase; compliance ( p < 0.007); the higher the compliance the better the e ff ect and start value at baseline ( p < 0.001); the higher the value at baseline, the smaller the increase, were all important factors for future trial design. No di ff erence in hand grip test values between placebo and treatment were noted at any time point. Muscle mass measured by Dexa scan showed no significant di ff erences between treatment groups (data not shown). Concentrations of circulating cytokines (TNF- α , IL-1 β and IL-6) and the inflammatory marker CRP were analyzed across 12 weeks in both cohorts. Total area under the curve (AUC) was used to compare the e ff ect of rice NPN supplementation on these markers over the entire study period. AUC for TNF- α compared to baseline showed a significantly greater reduction ( p = 0.03) for rice NPN compared to placebo (Figure 5a). When each study time point was subsequently assessed, at week 4 rice NPN was found to display a greater decrease ( p = 0.04) in circulating TNF- α from baseline than placebo (Figure 5b). While the overall decrease from baseline for TNF- α continued to be greater for rice NPN compared to placebo at week 8 and week 12, this was not significant and diminished with each consecutive time point (Figure 5b). AUC change from baseline for IL-1 β , IL-6 and CRP showed no significant di ff erences between treatment groups (see Figure S4a–c, respectively).
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