Effect of Consumption of Caraway on Treatment of Obesity

Submitted by Anonymous (not verified) on
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.
Brief Title
Effect of Consumption of Caraway on Treatment of Obesity
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).
Categories
Obesity & Weight Management
Completion Date
Completion Date Type
Actual
Conditions
Obesity
Overweight
Eligibility Criteria
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
Inclusion Criteria
Inclusion Criteria:

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

Gender
Female
Gender Based
false
Keywords
obesity
overweight
BMI
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
55 Years
Minimum Age
20 Years
NCT Id
NCT01833377
Org Class
Other
Org Full Name
University of Malaya
Org Study Id
NCT12345678
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Caraway Intake as a Sustainable Dietary Practice: Impact on Overweight & Obese Women
Primary Outcomes
Outcome Description
The changes in BMI from baseline at 12 weeks are measured.
Outcome Measure
Change in body mass index
Outcome Time Frame
Baseline and 12 weeks
Secondary Outcomes
Outcome Description
The changes in all blood parameters from baseline at 12 weeks are measured.
Outcome Time Frame
Baseline and 12 weeks
Outcome Measure
change in all blood parameters
Outcome Description
The changes in systolic and diastolic blood pressure and pulse rate from baseline at 12 weeks are measured.
Outcome Time Frame
Baseline and 12 weeks
Outcome Measure
Change in vital parameters (systolic and diastolic blood pressure and pulse rate)
Outcome Description
The changes in body weight from baseline at 12 weeks are measured.
Outcome Time Frame
Baseline and 12 weeks
Outcome Measure
Change in body weight
Outcome Description
The changes in anthropometric indices including waist, hip, thigh and mid-upper arm circumference from baseline at 12 weeks are measured.
Outcome Time Frame
Baseline and 12 weeks
Outcome Measure
Change in anthropometric indices including waist, hip, thigh and mid-upper arm circumference (cm)
Outcome Description
The changes in appetite from baseline at 12 weeks are measured.
Outcome Time Frame
Baseline and 12 weeks
Outcome Measure
Change in appetite
Outcome Description
The changes in body composition from baseline at 12 weeks are measured.
Outcome Time Frame
Baseline and 12 weeks
Outcome Measure
Change in body composition including fat percentage, muscle mass, lean body mass, bone mass and water percentage
Outcome Description
The changes in body weight from baseline at 12 weeks are measured.
Outcome Time Frame
Baseline and 12 weeks
Outcome Measure
Change in body weight (kg)
Outcome Description
The changes in BMR and AMR from baseline at 12 weeks are measured.
Outcome Time Frame
Baseline and 12 weeks
Outcome Measure
Change in basic and active metabolic rate
Outcome Description
Change in food intake

The changes in food intake (macro and micro nutrient intake) from baseline at 12 weeks are measured.
Outcome Time Frame
Baseline and 12 weeks
Outcome Measure
Change in food intake
Outcome Description
The changes in urine specific gravity from baseline at 12 weeks are measured.
Outcome Time Frame
Baseline and 12 weeks
Outcome Measure
Change in urine specific gravity
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
55
Minimum Age Number (converted to Years and rounded down)
20
Investigators
Investigator Type
Principal Investigator
Investigator Name
Denisa Ferastraoaru
Investigator Email
dferastr@montefiore.org
Investigator Phone
866-633-8255