NCT00795704

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Timeline
Completed

Started Apr 2008

Typical duration for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

August 9, 2012

Completed
Last Updated

August 9, 2012

Status Verified

June 1, 2012

Enrollment Period

2.1 years

First QC Date

November 19, 2008

Results QC Date

April 16, 2012

Last Update Submit

June 29, 2012

Conditions

Type 2 Diabetes

Keywords

Herbal SupplementType 2 DiabetesMulberryHemoglobin A1C

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1C

    3 month minus baseline

Secondary Outcomes (2)

  • Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels

    Baseline, 1 month, and 3 months

  • Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages

    Baseline and 3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Control Group

Drug: Placebo

Mulberry Leaf Extract

ACTIVE COMPARATOR
Drug: Mulberry Leaf Extract

Interventions

Mulberry Leaf ExtractDRUG

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

Also known as: Mulberry, Morus indica L., Morus alba
Mulberry Leaf Extract
PlaceboDRUG

Placebo 500 mg #2 capsules by mouth three times daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (5)

  • 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.

    PMID: 17472465BACKGROUND

  • 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.

    PMID: 17303787BACKGROUND

  • 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.

    PMID: 17071014BACKGROUND

  • 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.

    PMID: 16960168BACKGROUND

  • 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.

    PMID: 28619294DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Morus alba

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Daniel Riche
Organization
University of Mississippi Medical Center
driche@umc.edu
601-984-2640

Study Officials

  • Daniel M Riche, Pharm.D.

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pharmacy Practice and Medicine

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 21, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 9, 2012

Results First Posted

August 9, 2012

Record last verified: 2012-06

Locations

US(1)