Effect of Consumption of Caraway on Treatment of Obesity

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Dietary Supplement: caraway sample; Dietary Supplement: placebo

• Registration Number: NCT01833377
• Lead Sponsor: University of Malaya

Brief Summary

This study aims to investigate the applicability of caraway (black cumin) intake on the treatment of obesity. So, a randomized placebo controlled clinical trial will be conducted to examine the applicability of caraway product in terms of safety and efficacy.

Detailed Description

A randomized placebo-controlled clinical trial, was done on 120 healthy overweight and obese women aged 20-55 in Iran. data were collected trough questionaires, interview and physical examination. the required parameters including anthropometric indices, body composition vital parameters (heart rate and blood pressure)and full blood parameters, were measured before and after intervention. volunteers were randomized into test and control group and were asked to consume either caraway samples or placebo during 12 intervention weeks.

the outcome measure will be assessed for both primary and secondary data from baseline through week 12 (3 months).

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-03-26
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-15
• Last Update Submitted: 2013-04-15
• Study First Posted: 2013-04-16
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• overweight and obese women (BMI> 25)
• aged 20-55 years old
• healthy subjects

Exclusion Criteria

• Pregnant and lactating women
• Thyroid disease
• type I or II diabetes mellitus
• hypertension (systolic BP 140 and/or diastolic BP 90)
• endocrine dysfunction
• impaired liver function
• chronic renal disease
• cardiovascular disease
• primary dyslipidemia
• myopathy
• patients using drugs which affect on metabolism or appetite
• a maintained weight loss in the preceding 3 months
• meals not eaten at regular intervals
• participation in another investigation study within the past 30 days
• a history of alcohol or drug abuse within the past year
• smoking
• a history of sleep disorders
• clinical depression or other psychiatric conditions
• abnormal obese
• allergy or sensitivity to any of the 'active' or 'placebo' product ingredients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
caraway sample	caraway sample	caraway sample
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Change in body mass index	Baseline and 12 weeks	The changes in BMI from baseline at 12 weeks are measured.

Secondary Outcome Measures

Name	Time	Method
Change in appetite	Baseline and 12 weeks	The changes in appetite from baseline at 12 weeks are measured.
Change in anthropometric indices including waist, hip, thigh and mid-upper arm circumference (cm)	Baseline and 12 weeks	The changes in anthropometric indices including waist, hip, thigh and mid-upper arm circumference from baseline at 12 weeks are measured.
Change in body weight	Baseline and 12 weeks	The changes in body weight from baseline at 12 weeks are measured.
change in all blood parameters	Baseline and 12 weeks	The changes in all blood parameters from baseline at 12 weeks are measured.
Change in basic and active metabolic rate	Baseline and 12 weeks	The changes in BMR and AMR from baseline at 12 weeks are measured.
Change in vital parameters (systolic and diastolic blood pressure and pulse rate)	Baseline and 12 weeks	The changes in systolic and diastolic blood pressure and pulse rate from baseline at 12 weeks are measured.
Change in body composition including fat percentage, muscle mass, lean body mass, bone mass and water percentage	Baseline and 12 weeks	The changes in body composition from baseline at 12 weeks are measured.
Change in urine specific gravity	Baseline and 12 weeks	The changes in urine specific gravity from baseline at 12 weeks are measured.
Change in body weight (kg)	Baseline and 12 weeks	The changes in body weight from baseline at 12 weeks are measured.
Change in food intake	Baseline and 12 weeks	Change in food intake; The changes in food intake (macro and micro nutrient intake) from baseline at 12 weeks are measured.