Mulberry-extract improves glucose tolerance and decreases insulin concentrations in normoglycaemic adults: Results of a randomised double-blind placebo-controlled study.

BACKGROUND: High sugar and refined carbohydrate intake is associated with weight gain, increased incidence of diabetes and is linked with increased cardiovascular mortality. Reducing the health impact of poor quality carbohydrate intake is a public health priority. Reducose, a proprietary mulberry leaf extract (ME), may reduce blood glucose responses following dietary carbohydrate intake by reducing absorption of glucose from the gut. METHODS: A double-blind, randomised, repeat measure, phase 2 crossover design was used to study the glycaemic and insulinaemic response to one reference product and three test products at the Functional Food Centre, Oxford Brooks University, UK. Participants; 37 adults aged 19-59 years with a BMI ≥ 20kg/m2 and ≤ 30kg/m2. The objective was to determine the effect of three doses of mulberry-extract (Reducose) versus placebo on blood glucose and insulin responses when co-administered with 50g maltodextrin in normoglycaemic healthy adults. We also report the gastrointestinal tolerability of the mulberry extract. RESULTS: Thirty-seven participants completed the study: The difference in the positive Incremental Area Under the Curve (pIAUC) (glucose (mmol / L x h)) for half, normal and double dose ME compared with placebo was -6.1% (-18.2%, 5.9%; p = 0.316), -14.0% (-26.0%, -2.0%; p = 0.022) and -22.0% (-33.9%, -10.0%; p<0.001) respectively. The difference in the pIAUC (insulin (mIU / L x h)) for half, normal and double dose ME compared with placebo was -9.7% (-25.8%, 6.3%; p = 0.234), -23.8% (-39.9%, -7.8%; p = 0.004) and -24.7% (-40.8%, -8.6%; p = 0.003) respectively. There were no statistically significant differences between any of the 4 groups in the odds of experiencing one or more gastrointestinal symptoms (nausea, abdominal cramping, distension or flatulence). CONCLUSIONS: Mulberry leaf extract significantly reduces total blood glucose rise after ingestion of maltodextrin over 120 minutes. The pattern of effect demonstrates a classical dose response curve with significant effects over placebo. Importantly, total insulin rises were also significantly suppressed over the same time-period. There were no statistically significant differences between any of the treatment groups (including placebo) in the odds of experiencing one or more gastrointestinal symptoms. Mulberry extract may have multiple modes of action and further studies are necessary to evaluate ME as a potential target for the prevention of type 2 diabetes and the regulation of dysglycaemia.

Mulberry extract to modULate Blood glucosE Responses in noRmoglYcaemic adults (MULBERRY): study protocol for a randomised controlled trial.

BACKGROUND: Worldwide sugar consumption has tripled during the last fifty years. High sugar intake is associated with weight gain and increased incidence of diabetes and has been linked with increased cardiovascular mortality. Reducing the health impact of dietary sugar and poor quality carbohydrate intake is a public health priority. IminoNorm®, a proprietary mulberry leaf extract (ME), may reduce blood glucose responses following dietary sugar and carbohydrate intake by reducing absorption of glucose from the gut. Previous research has shown that ME can reduce blood glucose and improve insulin responses in healthy subjects and also in subjects with raised fasting blood glucose levels. Mulberry leaf has an excellent safety profile. This pilot study will test a novel, safe, water soluble product in normoglycaemic adults in the UK to determine if it can reduce glucose absorption without increasing plasma insulin concentration. METHODS/DESIGN: The trial will be a double-blind, individually randomised, four-arm single-dose crossover design to test the effect of three doses of ME in order to determine efficacy, dose response relationship and gastrointestinal side effects with respect to placebo. A total of 40 subjects will participate in this study and attend for four visits receiving each of the four interventions in random order. DISCUSSION: We aim to test the evidence that mulberry leaf extract can reduce blood glucose without a disproportionate increase in blood insulin responses in healthy individuals in a high-quality research study based in the UK. It is hoped that this will lead to further randomised controlled trials and an effective dietary supplement to lower blood glucose concentrations. ISRCTN: ISRCTN14597438 (21 April 2015).

Absolute and relative endocranial size in Neandertals and later Pleistocene Homo.

Eurasian Neandertals encompass the entire observed range of recent and fossil Homo sapiens in absolute, but not relative endocranial volume, and Neandertals attest an average EQ significantly lower than their Upper Pleistocene successors. While the cognitive, social, and evolutionary implications of this phenomenon have been emphasised, the statistical basis of a mean inference of EQ in the Neandertal hypodigm has not been appropriately demonstrated. A demonstrable male bias in the available postcranial, not cranial, series has skewed perceptions of Neandertal brain-to-body size scaling towards a rejection of the null hypothesis. A simple resolution to this problem is a concise assessment of paired associated covariates against a suitable recent human comparator series. Permutations of Fisher's z and Student's t statistics are valid metrics in tests of significance in single datum hypotheses. Bootstrapped single observation tests determined significance in body size, absolute and relative endocranial volume in Pleistocene archaic, early modern, and late Pleistocene H. sapiens. With respect to absolute ECV, all current Middle-Upper Pleistocene crania fall within the substantial recent Homo range. Nevertheless, simple indices derived from raw and modified data in normal and logarithmic space reveal that Western European Neandertal males approach the lower extremes of our observed size range in relative ECV, yet none exceed statistical significance. Results confirm that relative ECV/brain size in Neandertals was not significantly depressed relative to recent and fossil H. sapiens and this is consistent with a substantial body of data from living humans dismissing any simple correspondence of relative brain size with intelligence and, by extension, evolutionary success.