Dataset Information

Natural Magnesium-Enriched Deep-Sea Water Improves Insulin Resistance and the Lipid Profile of Prediabetic Adults: A Randomized, Double-Blinded Crossover Trial.

ABSTRACT: Previous in vitro and in vivo studies have shown that the antidiabetic effect of balanced deep-sea water (BDSW) works through the suppression of hyperglycemia and improvement of glucose tolerance. Based on these promising results, we conducted an eight week randomized, double-blinded crossover trial of the effects of BDSW in prediabetic adults. The subjects consumed 440 mL of BDSW (hardness 4000) per day, and maintained an otherwise normal lifestyle and diet throughout. Efficacy assessments were made by measuring fasting glucose, postprandial glucose, fasting insulin, homeostasis model assessment for insulin resistance (HOMA-IR), C-peptide, glycosylated hemoglobin, lipid metabolism indicators, and physical metrics, along with safety assessments. Fasting insulin and HOMA-IR values of the BDSW group were significantly lower than those of the placebo group after eight weeks of BDSW ingestion. Total cholesterol and low-density lipoprotein-cholesterol were also significantly decreased in the BDSW group after eight weeks of BDSW ingestion compared with the placebo group. There were no statistically and clinically meaningful changes in adverse events, physical examination, laboratory medicine examination, or vital signs of the BDSW intake group. These results suggested that the intake of BDSW in prediabetic adults can improve glucose metabolism and lipid profiles and is safe for human consumption.

SUBMITTER: Ham JY

PROVIDER: S-EPMC7071302 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Natural Magnesium-Enriched Deep-Sea Water Improves Insulin Resistance and the Lipid Profile of Prediabetic Adults: A Randomized, Double-Blinded Crossover Trial.

Ham Ji Yeon JY Shon Yun Hee YH

Nutrients 20200218 2

Previous in vitro and in vivo studies have shown that the antidiabetic effect of balanced deep-sea water (BDSW) works through the suppression of hyperglycemia and improvement of glucose tolerance. Based on these promising results, we conducted an eight week randomized, double-blinded crossover trial of the effects of BDSW in prediabetic adults. The subjects consumed 440 mL of BDSW (hardness 4000) per day, and maintained an otherwise normal lifestyle and diet throughout. Efficacy assessments were ...[more]

PMID: 32085495

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Project description:Aims/introductionPostmenopausal women receive bisphosphonates for osteoporosis treatment. The effect of these medications on developing diabetes mellitus in prediabetic patients is yet to be investigated. We aimed to determine the effect of alendronate on plasma glucose, insulin indices of postmenopausal women with prediabetes and osteopenia.Materials and methodsThe present triple-blind randomized controlled clinical trial included 60 postmenopausal women, aged 45-60 years. All patients were vitamin D sufficient. They were randomly enrolled in intervention (70 mg/week alendronate for 12 weeks) and control (placebo tablet per week for 12 weeks) groups. The morning 8-h fasting blood samples were collected at the baseline and follow-up visits to measure the fasting plasma glucose (mg/dL), insulin and hemoglobin A1c (HbA1c). Plasma glucose and insulin concentration were measured 30, 60 and 120 min after the glucose tolerance test. The Matsuda Index, homeostasis model assessment of insulin resistance, homeostasis model assessment of ?-cell function and the area under the curves of glucose and insulin were calculated.ResultsThe mean (standard deviation) fasting plasma glucose (102.43 [1.46] mg/dL vs 94.23 [1.17] mg/dL, P = 0.001), 120-min insulin concentration (101.86 [15.70] mU/L vs 72.60 [11.36] mU/L, P = 0.026), HbA1c (5.60 [0.06]% vs 5.40 [0.05]%, P = 0.001), homeostasis model assessment of insulin resistance (3.57 [0.45] vs 2.62 [0.24], P = 0.021) and Matsuda Index (7.7 [0.41] vs 9.2 [0.4], P = 0.001) significantly improved in the alendronate-treated group. There were more statistically significant reductions in fasting plasma glucose (-8.2 [8.63] mg/dL vs -2.5 [14.26] mg/dL, P = 0.002) and HbA1c (-0.2 [0.23]% vs -0.09 [0.26]%, P = 0.015) observed in the alendronate-treated group than the placebo group during the study course, respectively.ConclusionsAdministration of 70 mg/week alendronate improves fasting plasma glucose, HbA1c and insulin indices in postmenopausal women.

Project description:AIMS/HYPOTHESIS:Individuals of South Asian origin are at increased risk of developing type 2 diabetes mellitus and associated comorbidities compared with Europids. Disturbances in energy metabolism may contribute to this increased risk. Skeletal muscle and possibly also brown adipose tissue (BAT) are involved in human energy metabolism and nitric oxide (NO) is suggested to play a pivotal role in regulating mitochondrial biogenesis in both tissues. We aimed to investigate the effects of 6 weeks of supplementation with L-arginine, a precursor of NO, on energy metabolism by BAT and skeletal muscle, as well as glucose metabolism in South Asian men compared with men of European descent. METHODS:We included ten Dutch South Asian men (age 46.5?±?2.8 years, BMI 30.1?±?1.1 kg/m2) and ten Dutch men of European descent, that were similar with respect to age and BMI, with prediabetes (fasting plasma glucose level 5.6-6.9 mmol/l or plasma glucose levels 2 h after an OGTT 7.8-11.1 mmol/l). Participants took either L-arginine (9 g/day) or placebo orally for 6 weeks in a randomised double-blind crossover study. Participants were eligible to participate in the study when they were aged between 40 and 55 years, had a BMI between 25 and 35 kg/m2 and did not have type 2 diabetes. Furthermore, ethnicity was defined as having four grandparents of South Asian or white European origin, respectively. Blinding of treatment was done by the pharmacy (Hankintatukku) and an independent researcher from Leiden University Medical Center randomly assigned treatments by providing a coded list. All people involved in the study as well as participants were blinded to group assignment. After each intervention, glucose tolerance was determined by OGTT and basal metabolic rate (BMR) was determined by indirect calorimetry; BAT activity was assessed by cold-induced [18F]fluorodeoxyglucose ([18F]FDG) positron emission tomography-computed tomography scanning. In addition, a fasting skeletal muscle biopsy was taken and analysed ex vivo for respiratory capacity using a multisubstrate protocol. The primary study endpoint was the effect of L-arginine on BAT volume and activity. RESULTS:L-Arginine did not affect BMR, [18F]FDG uptake by BAT or skeletal muscle respiration in either ethnicity. During OGTT, L-arginine lowered plasma glucose concentrations (AUC0-2 h?-?9%, p?<?0.01), insulin excursion (AUC0-2 h?-?26%, p?<?0.05) and peak insulin concentrations (-26%, p?<?0.05) in Europid but not South Asian men. This coincided with enhanced cold-induced glucose oxidation (+44%, p?<?0.05) in Europids only. Of note, in skeletal muscle biopsies several respiration states were consistently lower in South Asian men compared with Europid men. CONCLUSIONS/INTERPRETATION:L-Arginine supplementation does not affect BMR, [18F]FDG uptake by BAT, or skeletal muscle mitochondrial respiration in Europid and South Asian overweight and prediabetic men. However, L-arginine improves glucose tolerance in Europids but not in South Asians. Furthermore, South Asian men have lower skeletal muscle oxidative capacity than men of European descent. FUNDING:This study was funded by the EU FP7 project DIABAT, the Netherlands Organization for Scientific Research, the Dutch Diabetes Research Foundation and the Dutch Heart Foundation. TRIAL REGISTRATION:ClinicalTrials.gov NCT02291458.

Project description:We determined whether oral consumption of Aronia, red ginseng, shiitake mushroom, and nattokinase mixture (3.4: 4.1: 2.4: 0.1 w/w; AGM) improved glucose metabolism and insulin resistance in prediabetic adults in a 12-week randomized, double-blinded clinical trial. Participants with fasting serum glucose concentrations of 100-140 mg/dL were recruited and randomly assigned to an AGM or placebo group. Participants of the AGM group (n = 40) were given an AGM granule containing 4 g of freeze-dried Aronia, red ginseng, shiitake mushroom, and nattokinase (3.4: 4.1: 2.4: 0.1 w/w) twice daily for 12 weeks, and the placebo group participants (n = 40) were provided with corn starch granules identical in appearance, weight, and flavor for 12 weeks. Serum glucose and insulin concentrations were measured during oral-glucose tolerance tests (OGTT) after administering 75 g of glucose in a fasted state. HOMA-IR, liver damage, and inflammation indices were determined, and safety parameters and adverse reactions were assessed. As determined by OGTT, serum glucose concentrations were not significantly different between the AGM and placebo groups after the intervention. However, changes in serum insulin concentrations in the fasted state and Homeostatic model assessment-insulin resistance (HOMA-IR) index after the intervention were significantly lower in the AGM group than in the placebo group (-3.07 ± 7.06 vs. 0.05 ± 6.12, p = 0.043 for serum insulin; -0.85 ± 2.14 vs. 0.07 ± 1.92, p = 0.049 for HOMA-IR). Serum adiponectin concentrations were reduced by intervention in the placebo group but not in the AGM group. Changes in liver damage indexes, including serum activities of the γ-glutamyl transferase, alanine aminotransferase, and aspartate aminotransferase, were lower in the AGM group and significantly reduced in the AGM group more than in the placebo group (p < 0.05). Changes in serum high sensitive-C-reactive protein concentrations in AGM and placebo groups were significantly different (-0.12 ± 0.81 vs. 0.51 ± 1.95, p = 0.06). In conclusion, AGM possibly improves insulin sensitivity and β-cell function and reduces liver damage and inflammation in prediabetic adults.

Dataset Information

Natural Magnesium-Enriched Deep-Sea Water Improves Insulin Resistance and the Lipid Profile of Prediabetic Adults: A Randomized, Double-Blinded Crossover Trial.

Publications

Natural Magnesium-Enriched Deep-Sea Water Improves Insulin Resistance and the Lipid Profile of Prediabetic Adults: A Randomized, Double-Blinded Crossover Trial.

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