NCT02455778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

May 25, 2015

Last Update Submit

May 28, 2015

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Fasting Blood Glucose

    baseline to 4 months

Secondary Outcomes (4)

  • HbA1c

    baseline to 4 months

  • Lipid profile

    baseline to 4 months

  • Body fat percentage

    baseline to 4 months

  • Blood pressure

    baseline to 4 months

Study Arms (2)

Cinnamon

EXPERIMENTAL

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

Dietary Supplement: Cinnamon

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

CinnamonDIETARY_SUPPLEMENT
Cinnamon
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Delhi, India

Location

Related Publications (1)

  • 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.

    PMID: 28606084DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 25, 2015

First Posted

May 28, 2015

Study Start

August 1, 2011

Primary Completion

November 1, 2012

Study Completion

April 1, 2013

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

IN(1)