Effect of Oral Cinnamon Intervention in Metabolic Syndrome

NCT ID: NCT02455778

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-04-30

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.

Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cinnamon

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

Group Type EXPERIMENTAL

Cinnamon

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Cinnamon

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of Home Economics, India

OTHER

Sponsor Role collaborator

Diabetes Foundation, India

OTHER

Sponsor Role lead

Responsible Party

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Dr Anoop Misra

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Delhi, , India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 28606084 (View on PubMed)

Other Identifiers

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Cinnamon 2010

Identifier Type: -

Identifier Source: org_study_id