Mulberry Leaf Extract and Blood Glucose Control in Diabetics

NCT01305434 | Completed Phase 1

• 1 other identifier: MLE-DM2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Mulberry leaf teas or extracts are used as a natural remedy for diabetes in some countries. Animal studies have shown some effect of mulberry leaf extract on blood glucose. The purpose of this trial is to assess the effect of mulberry leaf extract on type 2 diabetics, by measuring blood glucose two hours after eating a meal and taking a capsule containing either mulberry leaf extract or a placebo.

Conditions

Diabetes Mellitus Type 2

Keywords

diabetes mellitus type 2; mulberry leaf extract; post prandial blood glucose

Outcome Measures

Primary Outcomes (1)

• change in 2 hour post prandial blood glucose

  Success would be a change in pc glucose of -1.5 units (SI) greater than 70% of the time or in more than 70% of subject, and no increased incidence of hypoglycemia with the intervention

  6 weeks

Secondary Outcomes (1)

• number of subjects with adverse changes in creatinine, AST, ALT, and blood pressure due to intervention

  6 weeks

Study Arms (2)

Placebo then mulberry leaf

OTHER

These patients receive placebo for two weeks, then 1 week washout, then two weeks of mulberry leaf extract.

Dietary Supplement: Mulberry leaf extract effect on post prandial blood glucose

Mulberry leaf then placebo

OTHER

These patients receive mulberry leaf extract for two weeks, then 1 week washout, then two weeks of placebo.

Dietary Supplement: Mulberry leaf extract effect on post prandial blood glucose

Interventions

Mulberry leaf extract effect on post prandial blood glucose DIETARY_SUPPLEMENT

Mulberry leaf extract (400 mg, Mulberry Zuccarin, New Nordic) or placebo will be administered with meals to type 2 diabetics. Half the patients will receive mulberry leaf extract for the first two weeks and half will receive placebo. Following a one week wash out period, the interventions will be reversed for another 2 weeks, followed by a final wash out period. Subjects will keep diaries of food, exercise, daily fasting glucose, and at least one 2 hour pc glucose per day for the 6 weeks of the trial. Baseline renal function blood work and urine, liver function blood work, hemoglobin A1C, weight, and blood pressure will be done. These will be repeated at the end of each subject's 6 weeks in the trial. In addition, blood pressure will be checked with the distribution of the each 2 week batch of medications.

Also known as: Mulberry Zuccarin, 400 mg tablets. New Nordic (Sweden)

Mulberry leaf then placebo; Placebo then mulberry leaf

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• baseline hemoglobin A1C greater than or equal to 7.5 or fasting glucose greater than 7 (SI units)

You may not qualify if:

• on insulin
• history of hepatic or renal disease
• pregnant or nursing women

Sponsors & Collaborators

• Craig, Nancy, M.D.: lead

Study Sites (1)

Hope Medical Clinic

Edmonton, Alberta, T5B 2Y1, Canada

Location

Related Publications (11)

• Miyahara C, Miyazawa M, Satoh S, Sakai A, Mizusaki S. Inhibitory effects of mulberry leaf extract on postprandial hyperglycemia in normal rats. J Nutr Sci Vitaminol (Tokyo). 2004 Jun;50(3):161-4. doi: 10.3177/jnsv.50.161.

  PMID: 15386927 BACKGROUND

• Park JM, Bong HY, Jeong HI, Kim YK, Kim JY, Kwon O. Postprandial hypoglycemic effect of mulberry leaf in Goto-Kakizaki rats and counterpart control Wistar rats. Nutr Res Pract. 2009 Winter;3(4):272-8. doi: 10.4162/nrp.2009.3.4.272. Epub 2009 Dec 31.

  PMID: 20098579 BACKGROUND

• Andallu B, Varadacharyulu NCh. Antioxidant role of mulberry (Morus indica L. cv. Anantha) leaves in streptozotocin-diabetic rats. Clin Chim Acta. 2003 Dec;338(1-2):3-10. doi: 10.1016/s0009-8981(03)00322-x.

  PMID: 14637259 BACKGROUND

• Park MY, Lee KS, Sung MK. Effects of dietary mulberry, Korean red ginseng, and banaba on glucose homeostasis in relation to PPAR-alpha, PPAR-gamma, and LPL mRNA expressions. Life Sci. 2005 Nov 12;77(26):3344-54. doi: 10.1016/j.lfs.2005.05.043. Epub 2005 Jun 23.

  PMID: 15979095 BACKGROUND

• Naowaboot J, Pannangpetch P, Kukongviriyapan V, Kongyingyoes B, Kukongviriyapan U. Antihyperglycemic, antioxidant and antiglycation activities of mulberry leaf extract in streptozotocin-induced chronic diabetic rats. Plant Foods Hum Nutr. 2009 Jun;64(2):116-21. doi: 10.1007/s11130-009-0112-5.

  PMID: 19434497 BACKGROUND

• Oku T, Yamada M, Nakamura M, Sadamori N, Nakamura S. Inhibitory effects of extractives from leaves of Morus alba on human and rat small intestinal disaccharidase activity. Br J Nutr. 2006 May;95(5):933-8. doi: 10.1079/bjn20061746.

  PMID: 16611383 BACKGROUND

• 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: 17071014 BACKGROUND

• 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: 16960168 BACKGROUND

• 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: 17303787 BACKGROUND

• Andallu B, Suryakantham V, Lakshmi Srikanthi B, Reddy GK. Effect of mulberry (Morus indica L.) therapy on plasma and erythrocyte membrane lipids in patients with type 2 diabetes. Clin Chim Acta. 2001 Dec;314(1-2):47-53. doi: 10.1016/s0009-8981(01)00632-5.

  PMID: 11718678 BACKGROUND

• Nookabkaew S, Rangkadilok N, Satayavivad J. Determination of trace elements in herbal tea products and their infusions consumed in Thailand. J Agric Food Chem. 2006 Sep 6;54(18):6939-44. doi: 10.1021/jf060571w.

  PMID: 16939361 BACKGROUND

Related Links

• Another trial looking at a similar question (completed but not published at the time of this protocol)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nancy V Craig, MDCM

  PRINCIPAL INVESTIGATOR

• William R Craig, MD CM

  University of Alberta

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Nancy Craig

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 28, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

CA (1)