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| Date: 12-15-2015 | HC# 111561-534 |
Liu Y, Cotillard A, Vatier C, et al. A dietary supplement containing cinnamon, chromium and carnosine decreases fasting plasma glucose and increases lean mass in overweight or obese pre-diabetic subjects: a randomized, placebo-controlled trial. PLoS One. September 25, 2015;10(9):e0138646. doi: 10.1371/journal.pone.0138646.
Those with metabolic syndrome, characterized by abnormal glucose and insulin concentrations, are often at risk for developing type 2 diabetes mellitus (T2DM). This disease is prevalent worldwide and may be alleviated by medication and lifestyle modifications that focus on diet and exercise. Botanical therapies also may be useful as adjuncts to these therapies. Cassia (Cinnamomum aromaticum syn. C. cassia, Lauraceae) has been shown to be beneficial for T2DM and inflammation, but clinical studies are conflicted as to its efficacy. The mineral chromium also has been shown to modulate glycated hemoglobin (HbA1c) levels, and carnosine (a naturally occurring compound found in muscle and brain) may help potentiate any glycemic effects of cassia. This randomized, double-blind, placebo-controlled study tested the impact of a dietary supplement containing cassia, chromium, and carnosine on markers of metabolic syndrome in overweight or obese patients.
Included patients were from 25-65 years old, had a body mass index (BMI) of ≥ 25 kg/m2, fasting glucose between 5.55 mmol/L and 7 mmol/L, and no desire to employ lifestyle changes. Those with T2DM; kidney, liver, or thyroid problems; systemic diseases or disorders; or who had lost greater than 5% of their body weight in the last 6 months were excluded. Patients were also excluded if they took cassia/cinnamon, chromium, or supplements that target metabolism; were pregnant; might become pregnant; or were breastfeeding.
This study took place at the Institute of Cardiometabolism and Nutrition in Paris, France. A capsule of the dietary supplement (Glycabiane®; PiLeJe; Saint-Laurent-des-Autels, France) consisted of 228 mg of cassia bark extract (ChalCinn®; PiLeJe), 100 mg of l-carnosine, and 1.25 mg of chromium guanylate containing 10 µg of chromium chloride (Guanylor®; PiLeJe). [Note: It is mentioned that the cassia bark extract is "rich in polyphenol type-A polymers," but no concentrations of these compounds are given.] Inert ingredients of the treatment were silica, talc, magnesium stearate, and hydrated silica. Placebo capsules were identical in color, form, and smell but did not contain cassia bark extract, carnosine, or chromium, and contained 16 mg of silicon dioxide and 230.25 mg of microcrystalline cellulose. Two capsules of either treatment were taken daily at lunch for 4 months, with another 2 months of follow up. Patients were requested to make no lifestyle modifications during the study. Diaries and the number of unconsumed capsules were used to gauge compliance.
The primary endpoint was the impact on fasting glucose; secondary endpoints included modifications in fasting insulin, HbA1c levels, lipid profiles, markers of adiposity and inflammation, adipokines, and risk of cardiovascular disease. Markers of metabolism in adipose tissue also were measured and any lifestyle changes and adverse side effects monitored. From 220 recruited patients, 62 patients (40 women, 22 men) were included in the study and randomly assigned, with 30 in the treatment group and 32 in the placebo group. Ten patients (4 from the treatment group and 6 from the placebo group) were dropped prior to the final analysis due to noncompliance or loss during follow up. Baseline characteristics were not significantly different among all patients or per-protocol populations. There were no lifestyle modifications noted in either group.
At the end of the study, fasting glucose concentrations in the treatment group were significantly decreased in comparison to baseline (P=0.026). Also, the change in fasting glucose was significantly greater in the treatment group compared with the placebo group (P=0.02). No significant changes in fasting glucose concentrations were observed in the placebo group. In the treatment group, the authors describe 3 patterns of efficacy as follows: for 6 patients, fasting glucose concentrations were lowered during treatment and continued to decrease during the follow-up period; for 11 patients, treatment resulted in decreased fasting glucose that increased to baseline concentrations at the end of the study; and for 9 patients, fasting glucose was slightly elevated throughout treatment, continuing at this concentration for the study's duration. In the placebo group, patients either had decreased fasting glucose concentrations that stabilized during the study (17) or an increase followed by a decrease at the end of the study (9).
In both groups, HbA1c levels significantly increased (P<0.05), while homeostasis model assessment of β-cell function (HOMA-B%, a gauge of insulin secretion) significantly increased in the treatment group from baseline (P=0.043). Fasting insulin concentrations increased (nonsignificant) in the treatment group (9.4 ± 3.5 µU/ml vs. 9.9 ± 3.9 µU/ml, P=0.25); a decrease, also nonsignificant, was observed in the placebo group. For those in both groups, fasting glucose was significantly negatively correlated with insulin secretion (P=0.04 and P=0.001, respectively). At the end of the study, change in fat-free mass was significantly greater (increase) in the treatment group as compared with the placebo group (decrease) (P<0.05). In the treatment group, there was a significant correlation between increased fat-free mass and insulin sensitivity (P=0.007). Additionally, there was a significant negative correlation of fat-free mass increase with elevated free fatty acids (P=0.004). Patient triglycerides, cholesterol, free fatty acids, adipokine concentrations, inflammation markers, and adipose tissue metabolism were unchanged in both groups. Adverse side effects were similar in both groups and determined not to be due to the study treatment.
The authors conclude that the most dramatic effects in fasting glucose occurred in those with the most elevated fasting glucose and lowest interleukin-6 (IL-6, an inflammation marker) concentrations at baseline. Those with the greatest reduction in fasting glucose were younger in age and had less inflammation, greater concentrations of high-density lipoprotein (HDL) cholesterol, and less adiponectin at baseline.
In summary, this study shows that a combination of cinnamon, chromium, and carnosine was effective in decreasing elevated fasting glucose concentrations in overweight and obese patients, suggesting its use in the prevention of T2DM. It is noted that the significant effect of the treatment on fasting glucose is not in tandem with any effect on HbA1c status, perhaps indicative of the differing sensitivity of these measurements. (In fact, HbA1c elevation was significant in both groups, raising questions about the utility of this measurement.) In agreement with other work, this study shows a beneficial effect of the treatment on lean body mass, indicating its usefulness for multiple aspects of metabolic syndrome. Conversely, no effects were noted on cholesterol concentrations or inflammation markers. Further studies are necessary to fully understand the bioactive mechanisms of this treatment and its potential use along with diet and exercise changes for patients at risk of T2DM.
PiLeJe provided funding for this study; 3 authors are employed by PiLeJe (C. Langlois, A. Brochot, and A. Guilbot), 1 author received a grant from PiLeJe (A. Cotillard), and 2 authors received fees from PiLeJe (O. Allatif and Y. Liu).
—Amy C. Keller, PhD
