Effect of Oral Cinnamon Intervention in Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Cinnamon

• Registration Number: NCT02455778
• Lead Sponsor: Diabetes Foundation, India

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-11
• Study Completion: 2013-04
• Status Verified: 2015-05
• Study First Submitted: 2015-05-25
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-28
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1. Subjects aged between 25 -65 years

2. Subjects identified with any three of following:

   1. Fasting blood glucose ≥100 mg/ dL
   2. Waist circumference ≥ 90 cm ( males) ≥ 80 cm (females)
   3. Triglycerides ≥ 150 mg/dL
   4. High density lipoprotein cholesterol ≤ 40 mg/dL ( in males) , ≤ 50 mg/dL (in females)
   5. Blood pressure Systolic BP ≥ 130 mm Hg
   6. Diastolic BP ≥ 85 mm Hg

3. Subjects who were willing to participate in the study.

4. 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

1. Subjects suffering from other chronic diseases and metabolic complications such as cardiovascular disease, diabetes, renal disease, myocardial infarction and other endocrine disorders.
2. Subjects who were allergic to wheat flour and cinnamon.
3. Subjects who were on medication of anti dyslipidemic or hypoglycemic drugs.
4. Subjects who had undergone bypass procedure.
5. Subjects suffering from any debilitating disease such as tuberculosis, HIV etc.
6. Subjects suffering from uncontrolled hypothyroidism/ hyperthyroidism
7. Pregnant and lactating mothers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2.5 grams of wheat flour per day in form of capsules ( 6) along with standard diet and exercise protocol
Cinnamon	Cinnamon	3 grams of oral cinnamon per day in form of capsules (6) along with standard diet and exercise protocol

Primary Outcome Measures

Name	Time	Method
Fasting Blood Glucose	baseline to 4 months

Secondary Outcome Measures

Name	Time	Method
HbA1c	baseline to 4 months
Lipid profile	baseline to 4 months
Body fat percentage	baseline to 4 months
Blood pressure	baseline to 4 months

Trial Locations

Locations (1)

Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology; 🇮🇳 Delhi, India