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

Mulberry extract to modULate Blood glucosE Responses in noRmoglYcaemic adults (MULBERRY): study protocol for a randomized controlled trial
Mulberry extract to modULate Blood glucosE Responses in noRmoglYcaemic adults (MULBERRY): study protocol for a randomized 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
mulberry, glycaemic response, insulinaemic response
1745-6215
1-6
Lown, M.
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Fuller, R.
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Lightowler, H.
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Fraser, A.
2d1912cf-9bfb-4697-b8bf-cd855ff94ceb
Gallagher, A.
ea117e9a-41b1-44f7-9e86-b5960241f9fa
Stuart, B.
626862fc-892b-4f6d-9cbb-7a8d7172b209
Byrne, C.
1370b997-cead-4229-83a7-53301ed2a43c
Lewith, G.
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Lown, M.
4742d5f8-bcf3-4e0b-811c-920e7d010c9b
Fuller, R.
8512c0e2-c966-4a72-aadd-9f5d780a5420
Lightowler, H.
531fb9f5-6a81-4199-b922-f11f09d24ac7
Fraser, A.
2d1912cf-9bfb-4697-b8bf-cd855ff94ceb
Gallagher, A.
ea117e9a-41b1-44f7-9e86-b5960241f9fa
Stuart, B.
626862fc-892b-4f6d-9cbb-7a8d7172b209
Byrne, C.
1370b997-cead-4229-83a7-53301ed2a43c
Lewith, G.
0fc483fa-f17b-47c5-94d9-5c15e65a7625

Lown, M., Fuller, R., Lightowler, H., Fraser, A., Gallagher, A., Stuart, B., Byrne, C. and Lewith, G. (2015) Mulberry extract to modULate Blood glucosE Responses in noRmoglYcaemic adults (MULBERRY): study protocol for a randomized controlled trial. Trials, 16, 1-6, [486]. (doi:10.1186/s13063-015-0997-2). (PMID:26511964)

Record type: Article

Abstract

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

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Oct 2015 Lown et al Mulberry Trials 30 07 15 - Accepted Manuscript
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s13063-015-0997-2 - Version of Record
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More information

Accepted/In Press date: 2 October 2015
e-pub ahead of print date: 28 October 2015
Published date: 2015
Keywords: mulberry, glycaemic response, insulinaemic response
Organisations: Human Development & Health

Identifiers

Local EPrints ID: 383192
URI: http://eprints.soton.ac.uk/id/eprint/383192
ISSN: 1745-6215
PURE UUID: 57ff62cb-f1e3-496a-a6f5-e669b6bcd3b2
ORCID for M. Lown: ORCID iD orcid.org/0000-0001-8309-568X
ORCID for B. Stuart: ORCID iD orcid.org/0000-0001-5432-7437
ORCID for C. Byrne: ORCID iD orcid.org/0000-0001-6322-7753

Catalogue record

Date deposited: 12 Nov 2015 09:38
Last modified: 10 Jan 2022 03:04

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Contributors

Author: M. Lown ORCID iD
Author: R. Fuller
Author: H. Lightowler
Author: A. Fraser
Author: A. Gallagher
Author: B. Stuart ORCID iD
Author: C. Byrne ORCID iD
Author: G. Lewith

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