Is There a Metabolic Effect of Cinnamon on HbA1c, Blood Pressure and Serum Lipids in Type 2 Diabetes Mellitus?
NCT ID: NCT00846898
Last Updated: 2011-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2008-03-31
2009-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Wembley Health Care centre, NHS, UK.
UNKNOWN
Monks Park Primary care centre, NHS UK.
UNKNOWN
Willesden Health centre, NHS, UK.
UNKNOWN
Thames Valley University
OTHER
Responsible Party
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Thames Valley University
Principal Investigators
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Amalia Tsiami, PhD,MSc,BSc
Role: STUDY_DIRECTOR
Thames Valley University
Locations
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Brent teaching Primary Care trust (NHS)
Wembley, London, United Kingdom
Countries
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Other Identifiers
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07/H0717/47
Identifier Type: -
Identifier Source: org_study_id