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Impact of Mulberry Leaf on Type 2 Diabetes

NCT ID: NCT00795704

Last Updated: 2012-08-09

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study is to evaluate whether mulberry leaf extract will help control blood sugar in patients with type 2 diabetes. We also want to look at the safety of mulberry leaf extract in these patients.

Detailed Description

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The methods for testing this hypothesis include: a 2-week placebo run-in, followed by a double-blind randomization into 2 groups: (1) mulberry leaf extract and (2) matching placebo. Evaluations of hemoglobin A1C (A1C) -- A measurement of blood glucose over the past 3 months -- will be done at baseline \[before placebo run-in period\] and 3 months. Evaluations of safety laboratories and adverse effect questionnaire will be done at 4 weeks and at 3 months following the randomization visit. Subjects will undergo a 2-week placebo run-in phase, and then will be divided into two groups: (1) mulberry leaf extract and (2) matching placebo. The subjects will ingest 1000 mg (#2 500 mg capsules) of standardized mulberry leaf extract (Nature-Gen, San Diego, CA) or matching placebo three times daily with meals for 3 months. Patients will be asked to monitor fasting morning blood glucose and 2-hour postprandial dinner blood glucose daily during the 2-week placebo run-in. To ensure compliance, only subjects compliant with both medication and monitoring instructions will be issued a 30-day supply of study medication at enrollment and the remainder at the 4-week safety visit. Each visit will consist of clinical examination, completed questionnaires, evaluation of self-monitoring blood glucose (SMBG), and donated blood for clinical laboratory tests. Standard recommendations for therapeutic lifestyle intervention will be given to both groups. All the clinical laboratory tests will be performed at the University of Mississippi Medical Center. All patients will receive identical 2-week placebo phase capsules, and then be randomized to each group using similar lookin

Conditions

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Type 2 Diabetes

Keywords

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Herbal Supplement Type 2 Diabetes Mulberry Hemoglobin A1C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Control Group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 500 mg #2 capsules by mouth three times daily

Mulberry Leaf Extract

Group Type ACTIVE_COMPARATOR

Mulberry Leaf Extract

Intervention Type DRUG

Mulberry Leaf Extract 1000 mg by mouth three times daily for 3 months

Interventions

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Mulberry Leaf Extract

Mulberry Leaf Extract 1000 mg by mouth three times daily for 3 months

Intervention Type DRUG

Placebo

Placebo 500 mg #2 capsules by mouth three times daily

Intervention Type DRUG

Other Intervention Names

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Mulberry Morus indica L. Morus alba

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* No diabetes medication adjustments for at least 2 months
* Stable hemoglobin A1C \[Between 7.0% to 8.0% (inclusive) and not varying by more than 10% since prior visit; If no A1C exists prior to the current visit and no medication adjustments are made, the current A1C may used as the baseline\]

Exclusion Criteria

* On insulin
* History of overt cardiovascular disease
* History of missed appointments or non-compliance with medications
* History of hepatic or renal insufficiency
* History of hemoglobinopathies
* Women of reproductive potential not on oral contraceptives
* Pregnant/nursing women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Daniel Riche

Assistant Professor of Pharmacy Practice and Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel M Riche, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

References

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Andallu B, Varadacharyulu NC. Gluconeogenic substrates and hepatic gluconeogenic enzymes in streptozotocin-diabetic rats: effect of mulberry (Morus indica L.) leaves. J Med Food. 2007 Mar;10(1):41-8. doi: 10.1089/jmf.2005.034.

Reference Type BACKGROUND
PMID: 17472465 (View on PubMed)

Mudra M, Ercan-Fang N, Zhong L, Furne J, Levitt M. Influence of mulberry leaf extract on the blood glucose and breath hydrogen response to ingestion of 75 g sucrose by type 2 diabetic and control subjects. Diabetes Care. 2007 May;30(5):1272-4. doi: 10.2337/dc06-2120. Epub 2007 Feb 15. No abstract available.

Reference Type BACKGROUND
PMID: 17303787 (View on PubMed)

Hansawasdi C, Kawabata J. Alpha-glucosidase inhibitory effect of mulberry (Morus alba) leaves on Caco-2. Fitoterapia. 2006 Dec;77(7-8):568-73. doi: 10.1016/j.fitote.2006.09.003. Epub 2006 Sep 22.

Reference Type BACKGROUND
PMID: 17071014 (View on PubMed)

Zhong L, Furne JK, Levitt MD. An extract of black, green, and mulberry teas causes malabsorption of carbohydrate but not of triacylglycerol in healthy volunteers. Am J Clin Nutr. 2006 Sep;84(3):551-5. doi: 10.1093/ajcn/84.3.551.

Reference Type BACKGROUND
PMID: 16960168 (View on PubMed)

Riche DM, Riche KD, East HE, Barrett EK, May WL. Impact of mulberry leaf extract on type 2 diabetes (Mul-DM): A randomized, placebo-controlled pilot study. Complement Ther Med. 2017 Jun;32:105-108. doi: 10.1016/j.ctim.2017.04.006. Epub 2017 Apr 27.

Reference Type DERIVED
PMID: 28619294 (View on PubMed)

Other Identifiers

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2008-0053

Identifier Type: -

Identifier Source: org_study_id