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Is There a Metabolic Effect of Cinnamon on HbA1c, Blood Pressure and Serum Lipids in Type 2 Diabetes Mellitus? (cinnamon)

This study has been completed.
Sponsor:
Collaborators:
Wembley Health Care centre, NHS, UK.
Monks Park Primary care centre, NHS UK.
Willesden Health centre, NHS, UK.
Information provided by:
Thames Valley University
ClinicalTrials.gov Identifier:
NCT00846898
First received: February 18, 2009
Last updated: November 11, 2011
Last verified: February 2009
History of Changes
  Purpose

The aim of the study is to assess whether dietary supplementation of cinnamon (cinnamon cassia) has the potential to improve HbA1c, blood pressure and serum lipid measurements in patients with type 2 diabetes mellitus.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Dietary Supplement: cinnamon 2g per day for 12 weeks
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Dietary Supplementation of Cinnamon (Cinnamon Cassia) on HbA1c, Blood Pressure and Serum Lipid Measurements in Patients With Type 2 Diabetes Mellitus: a Randomised Placebo Controlled, Double Blind Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thames Valley University:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma glucose concentration Plasma lipid profiles (HDL, LDL, Triglycerides and total cholesterol) systolic and diastolic blood pressures. Body Mass Index. Waist circumference. Total calorie intake. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: March 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cinnamon
Subjects in this group will receive cinnamon capsules for 12 weeks period. The 2 g dose of cinnamon will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals.
 Dietary Supplement: cinnamon 2g per day for 12 weeks
Subjects in intervention group will receive cinnamon capsules for 12 weeks period. The 2 g dose of cinnamon will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals.
Other Name: cinnamon
Placebo Comparator: Control
Subjects in this group will receive placebo capsules (starch flour) for 12 weeks period. The 2 g dose of starch capsules will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals.
 Dietary Supplement: cinnamon 2g per day for 12 weeks
Subjects in intervention group will receive cinnamon capsules for 12 weeks period. The 2 g dose of cinnamon will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals.
Other Name: cinnamon

Detailed Description:

The study will be conducted for 3 months (12 weeks) with 58 individuals diagnosed with type 2 diabetes mellitus. The randomisation will be carried out by using a randomisation list. Cinnamon bark (cinnamon cassia) and starch flour (placebo) capsules will be purchased from a local pharmaceutical company in UK; these are freely available for over the counter use. Each capsule contained either 500 mg of cinnamon powder or starch flour. The cinnamon and placebo (starch flour) capsules will be packaged in a non transparent plastic bags.

The patients will be randomly allocated into the two groups of:

Group 1: placebo control group Group 2: cinnamon group

Patients in both placebo and cinnamon groups will receive treatment similar to the treatment they would normally receive from their respective NHS or primary care trust for 12 weeks.

Data collection:

After the randomisation the subjects will be scheduled to visit the clinic at 0 weeks, 6 - 7 weeks and 12 weeks from the beginning of the study. During every visit (week 0, weeks 6 - 7 and week 12) a 3-day diet diary will be collected and the intake of total calories, fats, carbohydrates, proteins and fibre will be determined. Compliance with the diet will be monitored by individual discussions at each clinical visit with dietician and compared with the diet diary. The anthropometric measurements of body weight, height, waist and hip circumferences will be measured before the trial (week 0), during the trial (weeks 6 - 7) and after the trial (week 12) period. The recorded clinical measurements of blood profiles include HbA1c level, fasting plasma glucose concentration and serum lipid profiles including serum total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and serum triglycerides, systolic and diastolic blood pressures will be measured at the baseline (week 0) and at 12 weeks during the study period.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients diagnosed with type 2 diabetes mellitus
  2. Aged over 18 years, either sex
  3. HbA1c level more than 7%
  4. Patients treated only with oral anti-diabetic drugs or diet

Exclusion Criteria:

  1. Patients with severe health problems including renal disease, liver disease, cardiovascular disease and other chronic ill health conditions
  2. Patients with mental health problems
  3. Patients treated with insulin therapy
  4. Patients refused to give informed consent
  5. Pregnant and lactating women
  6. Patients taking cinnamon supplements and other herbal supplements known to be effective
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846898

Locations
United Kingdom
Brent teaching Primary Care trust (NHS)
Wembley, London, United Kingdom, HA0 4UZ
Sponsors and Collaborators
Thames Valley University
Wembley Health Care centre, NHS, UK.
Monks Park Primary care centre, NHS UK.
Willesden Health centre, NHS, UK.
Investigators
Study Director: Amalia Tsiami, PhD,MSc,BSc Thames Valley University
  More Information

No publications provided

Responsible Party: Nicky Robinson, Thames Valley University
ClinicalTrials.gov Identifier: NCT00846898     History of Changes
Other Study ID Numbers: 07/H0717/47
Study First Received: February 18, 2009
Last Updated: November 11, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Thames Valley University:
blood sugar
cholesterol
cinnamon
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 26, 2012