Dataset Information

A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes.

ABSTRACT:

Introduction

Reducing postprandial (PP) hyperglycemia and PP glucose excursions is important for overall glycemic management. Although most therapeutic lifestyle interventions that reduce caloric intake would affect this, there is no particular nutritional intervention favored.

Methods

We evaluated the effects of a novel natural food adjuvant combining mulberry leaf extract (MLE) with other bioactive ingredients, in people with type 2 diabetes (T2D) originating from Asia, on improving PP glucometabolic response in a randomized controlled exploratory crossover, two-center study (USA, Singapore). A 2-g blend of 250 mg MLE [containing 12.5 mg of 1-deoxynojirimycin (DNJ)], fiber (1.75 g), vitamin D₃ (0.75 μg), and chromium (75 μg), compared with a similar blend without the MLE, was sprinkled over a 350-kcal breakfast meal (55.4 g carbs) and PP blood glucose (primary exploratory endpoint), insulin, and incretin hormones (GLP-1, GIP) were evaluated in blood samples over 3 h. Changes in incremental areas under the concentration curve (iAUC) and maximum concentrations (C_max) were compared.

Results

Thirty individuals (12 women, mean age 59 years, HbA1c 7.1%, BMI 26.5 kg/m²) were enrolled and the MLE-based blend relative to the blend without MLE significantly reduced glucose iAUC at 1 h (- 20%, p < 0.0001), 2 h (- 17%, p = 0.0001), and 3 h (- 15%, p = 0.0032) and C_max [mean (95% CI) difference - 0.8 (- 1.2, - 0.3) mmol/L, p = 0.0006]. A statistically significant reduction in 1 h insulin iAUC (- 24%, p = 0.0236) was observed, but this reduction was no longer present at either 2 h or 3 h. No difference in GLP-1 was seen, but GIP response (iAUC and C_max) was less with the MLE-based blend.

Conclusions

The observation of a significant glucose reduction paralleled with a significant lower insulin response supports a reduced gastrointestinal glucose absorption. These results support the use of a 2-g natural blend of MLE, fiber, vitamin D, and chromium in T2D as a convenient dietary adjuvant to improve PP glucometabolic response.

Clinicaltrials

gov identifier NCT04877366.

SUBMITTER: Mohamed M

PROVIDER: S-EPMC10064401 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes.

Mohamed Mafauzy M Zagury Roberto Luis RL Bhaskaran Kalpana K Neutel Joel J Mohd Yusof Barakatun Nisak BN Mooney Linda L Yeo Lihe L Kirwan Bridget-Anne BA Aprikian Olivier O von Eynatten Maximilian M Johansen Odd Erik OE

Diabetes therapy : research, treatment and education of diabetes and related disorders 20230301 4

<h4>Introduction</h4>Reducing postprandial (PP) hyperglycemia and PP glucose excursions is important for overall glycemic management. Although most therapeutic lifestyle interventions that reduce caloric intake would affect this, there is no particular nutritional intervention favored.<h4>Methods</h4>We evaluated the effects of a novel natural food adjuvant combining mulberry leaf extract (MLE) with other bioactive ingredients, in people with type 2 diabetes (T2D) originating from Asia, on impro ...[more]

PMID: 36855010

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Project description:Background1-Deoxynojirimycin (DNJ), a component of mulberry leaf extract (MLE), reduces postprandial hyperglycemia by inhibiting intestinal a-glycosidase. The aim of this exploratory study was to investigate the effects of MLE on the glycemic indexes (GI) of common dietary carbohydrates.MethodsThis single-center, randomized, open-label, 7-cycle self-controlled crossover study enrolled 15 healthy volunteers at the National Drug Clinical Trial Institution, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine (June 2014 to December 2014). The participants were randomized to receive glucose (3 occasions), glucose+MLE, sucrose+MLE, maltose+MLE, and maltodextrin+MLE orally during 7 visits (every 3 days). Blood glucose level was tested at 15 minutes before and at 15, 30, 45, 60, 90, and 120 minutes after carbohydrate intake. The GI of each carbohydrate relative to glucose (GI = 100) was calculated using the incremental area under the curve method. Safety was assessed at each visit.ResultsAll participants completed the protocol. After carbohydrate ingestion, blood glucose level peaked at 30 minutes (glucose, glucose+MLE, sucrose+MLE, and maltose+MLE) or 45 minutes (maltodextrin+MLE) before returning to preprandial levels at 120 minutes. At 30 minutes, the change in blood glucose level was lower for sucrose+MLE, maltose+MLE, and maltodextrin+MLE than for glucose or glucose+MLE (P < .05). GI was lowest for sucrose+MLE (43.22 ± 17.47) and maltose+MLE (49.23 ± 22.39), intermediate for maltodextrin+MLE (75.90 ± 26.01), and higher for glucose+MLE (91.88 ± 27.24). MLE reduced the GIs for maltose, sucrose, maltodextrin, and glucose by 53.11%, 33.51%, 31.00%, and 8.12%, respectively. MLE was well tolerated.ConclusionsCoconsumption of MLE with sucrose, maltose, or maltodextrin can reduce the GI values of these carbohydrates.Trial registrationChinese Clinical Trial Registry Platform, no. ChiCTR-IPR-15006484. Registered on May 28, 2015.

Project description:Obesity is a chronic condition that has become a serious public health challenge globally due to the association with a high incidence of complications. Mulberry leaf is one of the most commonly used medicinal and herbal medicines that has been reported to ameliorate obesity and hyperlipidemia. However, the mechanism remains unclear. In the present study, a network pharmacology approach was used to explore the potential mechanism underlying the effects of mulberry leaf extract on obesity. First, the potential targets of mulberry leaf and obesity were predicted using SwissTargetPrediction, Online Mendelian Inheritance in Man, GeneCards and Comparative Toxicogenomics Database databases, which were then used to construct the protein-protein interaction networks. Gene ontology (GO) enrichment and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyzes were performed using R version 3.6.3. Finally, results of this network analysis were verified by using the mulberry leaf extract to treat high-fat diet-induced obese mice. In total, 24 target genes associated with obesity that could potentially be affected by mulberry leaf treatment were predicted by network pharmacology, using which top seven related pathways were determined by KEGG enrichment analysis. Triglyceride (TG) and total cholesterol (TC) levels in mice serum were detected using TG and TC assay kits. Hepatic fat accumulation was detected by H&E staining whereas liver lipid droplets were detected by Oil red O staining in mice tissues. The expression of IL-1β, NF-κB inhibitor α, inducible nitric oxide synthase, AMP-activated protein kinase (AMPK), sterol regulatory element-binding proteins and fatty acid synthase in the visceral white adipose tissues of mice was analyzed by western blotting. The expression of TNF-α, peroxisome proliferator activated receptor (PPAR)D, PPARG, fatty acid amide hydrolase (FAAH) and hydroxysteroid 11-β dehydrogenase 1 (HSD11B1) in the visceral white adipose tissues of mice was detected by reverse transcription-quantitative PCR. Mulberry leaf extract was found to reduce fat accumulation and hepatic lipid droplet formation. Mulberry leaf also alleviated inflammation and lipogenesis whilst promoting lipid catabolism and fatty acid oxidation by promoting the AMPK signaling pathway. The possible anti-obesity effects of mulberry leaf on the mice may be due to the downregulation of TNF-α, PPARD and PPARG and the upregulation of FAAH and HSD11B1. These results were consistent with the GO enrichment analysis and suggested that mulberry leaf may regulate lipid metabolism and catabolism, fatty acid metabolism and biosynthesis and the inflammatory response to reduce obesity.

Dataset Information

A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes.

Introduction

Methods

Results

Conclusions

Clinicaltrials

Publications

A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes.

Similar Datasets

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