Effect of Oral Cinnamon Intervention in Metabolic Syndrome

May 28, 2015 updated by: Dr Anoop Misra, Diabetes Foundation, India

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fasting Blood Glucose
Time Frame: baseline to 4 months
baseline to 4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diabetes Foundation, India

Collaborators

Institute of Home Economics, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 25, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cinnamon 2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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