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Effect of Oral Cinnamon Intervention in Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Cinnamon
Placebo
Sponsored by
Diabetes Foundation, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cinnamon

Placebo

Arm Description

3 grams of oral cinnamon per day in form of capsules (6) along with standard diet and exercise protocol

2.5 grams of wheat flour per day in form of capsules ( 6) along with standard diet and exercise protocol

Outcomes

Primary Outcome Measures

Fasting Blood Glucose

Secondary Outcome Measures

HbA1c
Lipid profile
Body fat percentage
Blood pressure

Full Information

First Posted
May 25, 2015
Last Updated
May 28, 2015
Sponsor
Diabetes Foundation, India
Collaborators
Institute of Home Economics, India
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1. Study Identification

Unique Protocol Identification Number
NCT02455778
Brief Title
Effect of Oral Cinnamon Intervention in Metabolic Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diabetes Foundation, India
Collaborators
Institute of Home Economics, India

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cinnamon
Arm Type
Experimental
Arm Description
3 grams of oral cinnamon per day in form of capsules (6) along with standard diet and exercise protocol
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2.5 grams of wheat flour per day in form of capsules ( 6) along with standard diet and exercise protocol
Intervention Type
Dietary Supplement
Intervention Name(s)
Cinnamon
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Fasting Blood Glucose
Time Frame
baseline to 4 months
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
baseline to 4 months
Title
Lipid profile
Time Frame
baseline to 4 months
Title
Body fat percentage
Time Frame
baseline to 4 months
Title
Blood pressure
Time Frame
baseline to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology
City
Delhi
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
28606084
Citation
Gupta Jain S, Puri S, Misra A, Gulati S, Mani K. Effect of oral cinnamon intervention on metabolic profile and body composition of Asian Indians with metabolic syndrome: a randomized double -blind control trial. Lipids Health Dis. 2017 Jun 12;16(1):113. doi: 10.1186/s12944-017-0504-8.
Results Reference
derived

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Effect of Oral Cinnamon Intervention in Metabolic Syndrome

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