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Effect of Oral Cinnamon Intervention in Metabolic Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02455778
Enrollment
103
Registered
2015-05-28
Start date
2011-08-31
Completion date
2013-04-30
Last updated
2015-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

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.

Interventions

DIETARY_SUPPLEMENTCinnamon
DIETARY_SUPPLEMENTPlacebo

Sponsors

Institute of Home Economics, India
CollaboratorOTHER
Diabetes Foundation, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Fasting Blood Glucosebaseline to 4 months

Secondary

MeasureTime frame
HbA1cbaseline to 4 months
Lipid profilebaseline to 4 months
Body fat percentagebaseline to 4 months
Blood pressurebaseline to 4 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026