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Randomized Controlled Trial
. 2015 Sep 25;10(9):e0138646.
doi: 10.1371/journal.pone.0138646. eCollection 2015.

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

Yuejun Liu  1 , Aurélie Cotillard  1 , Camille Vatier  2 , Jean-Philippe Bastard  3 , Soraya Fellahi  3 , Marie Stévant  4 , Omran Allatif  2 , Clotilde Langlois  5 , Séverine Bieuvelet  4 , Amandine Brochot  5 , Angèle Guilbot  5 , Karine Clément  1 , Salwa W Rizkalla  1
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Randomized Controlled Trial

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

Yuejun Liu et al. PLoS One. .

Erratum in

Abstract

Background: Preventing or slowing the progression of prediabetes to diabetes is a major therapeutic issue.

Objectives: Our aim was to evaluate the effects of 4-month treatment with a dietary supplement containing cinnamon, chromium and carnosine in moderately obese or overweight pre-diabetic subjects, the primary outcome being change in fasting plasma glucose (FPG) level. Other parameters of plasma glucose homeostasis, lipid profile, adiposity and inflammatory markers were also assessed.

Methods: In a randomized, double-blind, placebo-controlled study, 62 subjects with a FPG level ranging from 5.55 to 7 mmol/L and a body mass index ≥ 25 kg/m(2), unwilling to change their dietary and physical activity habits, were allocated to receive a 4-month treatment with either 1.2 g/day of the dietary supplement or placebo. Patients were followed up until 6 months post-randomization.

Results: Four-month treatment with the dietary supplement decreased FPG compared to placebo (-0.24 ± 0.50 vs +0.12 ± 0.59 mmol/L, respectively, p = 0.02), without detectable significant changes in HbA1c. Insulin sensitivity markers, plasma insulin, plasma lipids and inflammatory markers did not differ between the treatment groups. Although there were no significant differences in changes in body weight and energy or macronutrient intakes between the two groups, fat-free mass (%) increased with the dietary supplement compared to placebo (p = 0.02). Subjects with a higher FPG level and a milder inflammatory state at baseline benefited most from the dietary supplement.

Conclusions: Four-month treatment with a dietary supplement containing cinnamon, chromium and carnosine decreased FPG and increased fat-free mass in overweight or obese pre-diabetic subjects. These beneficial effects might open up new avenues in the prevention of diabetes.

Trial registration: ClinicalTrials.gov NCT01530685.

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Conflict of interest statement

Competing Interests: PileJe (Saint-Laurent-des-Autels, France) provided funding towards this study. SB, AG and CL are employed by PiLeJe; AC received a grant from PiLeJe, OA and YL received fees for data management and other study procedures on the behalf of PiLeJe, MS is employed by AdipoPhYt at the time of the study. There are no patents or products in development to declare. The tested product was marketed before the beginning of the study. Other: CV has received consultancy fees from AstraZeneca and Sanofi, support for travel and congress inscription from Novonordisk and Sanofi, and research materials from AstraZeneca; JPB has received speaker fees from the European Group for the Study of Insulin Resistance (EGIR) and from Servier and a research grant from the Association Nationale de la Recherche sur le SIDA (ANRS); SF has received support for congress attendance from Beckman Coulter; the other authors declare no conflict of interest. The above declarations have no effect on the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Consort flow diagram.
ITT: intention-to-treat. One subject in the dietary supplement group was lost to follow-up at Month 2, and one subject in the placebo group was withdrawn from the study at Month 2 due to a serious adverse event not related to study treatment (new condition with a need for hormonal treatment).
Fig 2
Fig 2. Correlations between changes in FPG or fat-free mass and other bioclinical parameters during dietary supplement treatment.
A: Correlation between changes in fasting plasma glucose and insulin secretion estimated by HOMA-B%. B: Correlations between changes in fat-free mass and changes in insulin sensitivity (estimated by revised QUICKI). C: Correlations between changes in fat-free mass and free fatty acids; N = 23 in A and B due to 3 missing data for plasma insulin, N = 26 subjects in C. Pearson correlations were used. D0: Day 0; M4: Month 4.
Fig 3
Fig 3. Correlations between changes in FPG or fat-free mass and other bioclinical parameters in the placebo group.
A: Correlation between changes in FPG and insulin secretion estimated by HOMA-B%. B: Correlations between changes in fat-free mass and changes in insulin sensitivity estimated by revised QUICKI. C: Correlations between changes in fat-free mass and free fatty acids; N = 22 in A and B due to 4 missing data for plasma insulin, N = 26 subjects in C. Pearson correlations were used. D0: Day 0; M4: Month 4.
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This work was supported by PileJe (Saint-Laurent-des-Autels, France), the study sponsor, as well as by INSERM and Pierre and Marie Curie University (Paris, France). The funders participated in the design and monitoring of the study, but had no role in data collection and analysis, decision to publish, or preparation of the manuscript.

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