Insulin sensitizer in prediabetes: a clinical study with DLBS3233, a combined bioactive fraction of Cinnamomum burmanii and Lagerstroemia speciosa

Abstract

BackgroundThe aim of this paper is to evaluate the efficacy and safety of DLBS3233, a novel bioactive fraction derived from Cinnamomum burmanii and Lagerstroemia speciosa, in improving insulin resistance and preserving β-cell performance in patients with impaired glucose tolerance (IGT).Patients and methodsEighty adult subjects with IGT, defined as 2-hour postprandial glucose level of 140–199 mg/dL, were enrolled in this two-arm, 12-week, double-blind, randomized, placebo-controlled preliminary study. Eligible subjects were randomly allocated to receive either DLBS3233 at a dose of 50–100 mg daily or placebo for 12 weeks. The study mainly assessed the improvement of homeostatic model-assessed insulin resistance (HOMA-IR), the 15-minute and 2-hour plasma insulin levels, and the oral disposition index.ResultsAfter 12 weeks, DLBS3233 improved insulin resistance better than placebo as reflected by a reduced HOMA-IR (−27.04%±29.41% vs −4.90%±41.27%, P=0.013). The improvement of the first- and second-phase insulin secretion was consistently greater in DLBS3233 group than placebo group (−144.78±194.06 vs −71.21±157.19, P=0.022, and −455.03±487.56 vs −269.49±467.77, P=0.033, respectively). Further, DLBS3233 also significantly better improved oral disposition index than placebo. No serious hypoglycemia, edema, or cardiovascular-related adverse events were found in either groups.ConclusionThis study has shown that DLBS3233 at the dose of 50–100 mg once daily was well tolerated, and promisingly efficacious in improving insulin sensitivity as well as preserving β-cell performance in subjects with IGT.

The Effect and Safety Assessment of Metformin and DLBS3233 (A Bioactive Fraction of Lagerstroemia speciosa and Cinnamomum burmannii) on Improving Metabolic Parameters in Women with Polycystic Ovary Syndrome

“…Based on the pharmacological activities of DLBS3233, known to improve insulin-signal transduction sensitivity, DLBS3233 may also benefit women with PCOS. 27 , 30 So far, there are no studies investigating the application of DLBS3233 to PCOS treatment. Therefore, in this study, DLBS3233 and its comparator (Metformin XR) will be used as a single pharmacological therapy on top of a lifestyle modification intervention.…”

<p>Gastroprotective Effect of DLBS2411 Bioactive Fraction from <em>Cinnamomum burmannii</em> Against Ethanol-Induced Gastric Damage in Rats</p>

“…The mechanism of action and molecular activities of various herbs have been investigated in vivo and in vitro in our previous studies. [5][6][7][8][9][10][11][12] In recent years, many studies have been carried out on isolation, determination of the phytochemical profile, and characterization of the pigments of Cinnamomum burmannii. 13,14 It has been recommended for medicinal use because it displays antibacterial 15 and antioxidant activities.…”

Polyherbal dietary supplementation for prediabetic adults: study protocol for a randomized controlled trial

“…A number of herbs have been used to manage symptoms related to deleterious changes in glucose metabolism [10–17]. A number of clinical studies of herbal interventions (i.e., cinnamon, fenugreek, banaba, curcumin, and others) conducted among adult populations with prediabetes have demonstrated improved glycemic control, particularly with regard to reducing fasting blood glucose [18–25] and postprandial glucose [18, 22, 26–29], HbA 1c [25, 30, 31], fasting insulin levels [9, 26, 28–31], homeostatic model of Insulin Resistance (HOMA-IR) [20, 28, 30, 32, 33], and increasing homeostatic model of β-cell function (HOMA-β) [27, 32]. Substantial changes in glycemic parameters typically occur within 12 weeks [34, 35].…”

“…Substantial changes in glycemic parameters typically occur within 12 weeks [34, 35]. Likewise, each of these outcomes have demonstrated significant changes over a 12-week duration in previous trials [19, 20, 22, 28, 29, 33, 36].…”

“…While many of these herbs appear to be promising when used in isolation, the practice of herbal medicine most often utilizes polyherbal combinations for purported synergistic effects [82]. Although a handful of polyherbal dietary supplement formulations [9, 20, 21, 33, 93, 94] have been examined for the improvement of glycemic control among prediabetic populations, no study has yet examined the potential impacts of berberine, ginseng, gymnema, banaba, cinnamon, fenugreek, and kudzu as a polyherbal formulation using a comprehensive panel of validated markers of lipid status and glycemic control (i.e., short-term, medium-term, and longer-term) utilized in both research and clinical practice.…”