Effect of Oral Cinnamon Intervention in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455778
• Other study ID #: Cinnamon 2010
• Status: Completed
• Phase: N/A
• First received: May 25, 2015
• Last updated: May 28, 2015
• Start date: August 2011
• Est. completion date: April 2013

Study information

• Verified date: May 2015
• Source: Diabetes Foundation, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Cinnamon

• Placebo

Locations

Country	Name	City	State
India	Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Diabetes Foundation, India	Institute of Home Economics, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Blood Glucose		baseline to 4 months	No
Secondary	HbA1c		baseline to 4 months	No
Secondary	Lipid profile		baseline to 4 months	No
Secondary	Body fat percentage		baseline to 4 months	No
Secondary	Blood pressure		baseline to 4 months	No