Effect of Oral Cinnamon Intervention in Metabolic Syndrome

Study Overview
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Brief Summary
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This double blind placebo control study with supplementation of oral Cinnamon is being conducted to test the hypothesis that in subjects with Metabolic Syndrome oral cinnamon may lead to improvement in body composition and metabolic parameters.

Official Title
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Effect of Intervention With Oral Cinnamon on Metabolic Profile and Body Composition of Asian Indians With Metabolic Syndrome in North India: A 16 Week Double Blind Placebo Control Trial

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Cinnamon
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged between 25 -65 years Subjects identified with any three of following: Fasting blood glucose ≥100 mg/ dL Waist circumference ≥ 90 cm ( males) ≥ 80 cm (females) Triglycerides ≥ 150 mg/dL High density lipoprotein cholesterol ≤ 40 mg/dL ( in males) , ≤ 50 mg/dL (in females) Blood pressure Systolic BP ≥ 130 mm Hg Diastolic BP ≥ 85 mm Hg Subjects who were willing to participate in the study. Subjects, if on medication for high blood pressure were stable and there was no change in the dosage for the past 3 months. Exclusion Criteria: Subjects suffering from other chronic diseases and metabolic complications such as cardiovascular disease, diabetes, renal disease, myocardial infarction and other endocrine disorders. Subjects who were allergic to wheat flour and cinnamon. Subjects who were on medication of anti dyslipidemic or hypoglycemic drugs. Subjects who had undergone bypass procedure. Subjects suffering from any debilitating disease such as tuberculosis, HIV etc. Subjects suffering from uncontrolled hypothyroidism/ hyperthyroidism Pregnant and lactating mothers

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cinnamon<br>3 grams of oral cinnamon per day in form of capsules (6) along with standard diet and exercise protocol | Dietary Supplement: Cinnamon<br> <br> |
| Placebo Comparator: Placebo<br>2.5 grams of wheat flour per day in form of capsules ( 6) along with standard diet and exercise protocol | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Blood Glucose |  | baseline to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | baseline to 4 months | 
| Lipid profile |  | baseline to 4 months | 
| Body fat percentage |  | baseline to 4 months | 
| Blood pressure |  | baseline to 4 months |