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NCT Number: NCT02455778

Effect of Oral Cinnamon Intervention in Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Delhi, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cinnamon

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Fasting Blood Glucose

    Time frame: baseline to 4 months

Secondary outcomes

  1. HbA1c

    Time frame: baseline to 4 months

  2. Lipid profile

    Time frame: baseline to 4 months

  3. Body fat percentage

    Time frame: baseline to 4 months

  4. Blood pressure

    Time frame: baseline to 4 months

Sponsors and collaborators

Lead sponsor

Diabetes Foundation, India

Other

Collaborators

  • Institute of Home Economics, India

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
May 28, 2015
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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