A novel nutritional supplement containing amino acids and chromium decreases postprandial glucose response in a randomized, double-blind, placebo-controlled study

Abstract

High postprandial blood glucose levels are associated with increased mortality, cardiovascular events and development of diabetes in the general population. Interventions targeting postprandial glucose have been shown to prevent both cardiovascular events and diabetes. This study evaluates the efficacy and safety of a novel nutritional supplement targeting postprandial glucose excursions in non-diabetic adults. Sixty overweight healthy male and female participants were recruited at two centers and randomized in a double-blind, placebo-controlled, crossover design. The supplement, a water-based drink containing 2.6g of amino acids (L-Leucine, L-Threonine, L-Lysine Monohydrochloride, L-Isoleucine, L-Valine) and 250 mcg of chromium picolinate, was consumed with a standardized carbohydrate-rich meal. The primary endpoint was the incremental area under the curve (iAUC) for venous blood glucose from 0 to 120 minutes. Secondary endpoints included glucose iAUC 0-180 minutes and the maximum glucose concentration (C max), for both venous and capillary blood glucose. In the intention-to-treat-analysis (n = 60) the supplement resulted in a decreased venous blood glucose iAUC 0-120min compared to placebo, mean (SE) of 68.7 (6.6) versus 52.2 (6.8) respectively, a difference of-16.5 mmol/L•min (95% CI-3.1 to-30.0, p = 0.017). The C max for venous blood glucose for the supplement and placebo were 6.45 (0.12) versus 6.10 (<0.12), respectively, a difference of-0.35 mmol/L (95% CI-0.17 to-0.53, p<0.001). In the per protocol-analysis (n = 48), the supplement resulted in a decreased C max compared to placebo from 6.42 (0.14) to 6.12 (0.14), a difference of-0.29 mmol/L (95% CI-0.12 to-0.47, p = 0.002). No significant differences in capillary blood glucose were found, as measured by regular bedside glucometers. The nutritional supplement drink containing amino acids and chromium improves the postprandial glucose homeostasis in overweight adults without diabetes. Future studies should clarify, whether regular consumption of the

Continuous glucose monitoring as a close to real life alternative to meal studies – a pilot study with a functional drink containing amino acids and chromium

“…The positive effects of early insulin have convincingly been shown both in healthy individuals and diabetes patients ( 37 , 38 ). In addition, effects of FD on GLP-1 and GIP could influence the effects observed in this study ( 24 , 39 ). The current results also show that the effect of FD/FDJ on postprandial glucose is sustained and can be achieved in repeated meals over the course of the day.…”

“…While no significant reduction in postprandial glycemia was found when comparing the FD to placebo on its own, FD with added carbohydrate-containing juice (FDJ) as well as the combination of FD and FDJ, demonstrated a pronounced and significant effect on iAUC 0−120 (adjusted for the meal composition). Higher efficacy of FDJ compared to FD suggests an enhanced postprandial glucose lowering with an increasing carbohydrate load, a situation in which the improved early insulin response previously shown for FD (without changing total iAUC for insulin) ( 24 , 29 ) could be even more beneficial for postprandial glucose disposal. The positive effects of early insulin have convincingly been shown both in healthy individuals and diabetes patients ( 37 , 38 ).…”

“…In the previously performed meal study ( 24 ), significant effects were found in the per protocol population which consisted of 48 participants for FD and placebo, respectively, thus 96 meals in total. We estimated that to achieve a similar or higher number of meals per test drink with one run-in day and 9 study days, studying three meals a day, would require 6 participants.…”

“…In a previous double-blinded study it was shown that FD, flavored water containing the free amino acids leucine, isoleucine, valine, lysine and threonine, as well as chromium picolinate, was able to reduce the postprandial response (iAUC) to a carbohydrate-rich meal by 24% ( 24 ). These results were obtained in healthy, overweight individuals in a meal experiment under controlled laboratory settings ( 24 ).…”

“…In a previous double-blinded study it was shown that FD, flavored water containing the free amino acids leucine, isoleucine, valine, lysine and threonine, as well as chromium picolinate, was able to reduce the postprandial response (iAUC) to a carbohydrate-rich meal by 24% ( 24 ). These results were obtained in healthy, overweight individuals in a meal experiment under controlled laboratory settings ( 24 ). Being the gold standard for the assessment of postprandial glycemic response to different foods, meal studies require trained staff, are costly and have to be performed under standardized laboratory conditions ( 23 ).…”