Effect of Oral Cinnamon Intervention in Metabolic Syndrome

Diabetes Foundation, India

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Cinnamon

Study type: Interventional

Funder types: Other

Identifiers

NCT02455778

Cinnamon 2010

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 2 patient groups, including a placebo group

Cinnamon

Experimental group

Description:

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

Treatment:

Dietary Supplement: Cinnamon

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo