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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Change in body mass index
The changes in BMI from baseline at 12 weeks are measured.
Time frame: Baseline and 12 weeks
change in all blood parameters
The changes in all blood parameters from baseline at 12 weeks are measured.
Time frame: Baseline and 12 weeks
Change in vital parameters (systolic and diastolic blood pressure and pulse rate)
The changes in systolic and diastolic blood pressure and pulse rate from baseline at 12 weeks are measured.
Time frame: Baseline and 12 weeks
Change in body weight
The changes in body weight from baseline at 12 weeks are measured.
Time frame: Baseline and 12 weeks
Change in anthropometric indices including waist, hip, thigh and mid-upper arm circumference (cm)
The changes in anthropometric indices including waist, hip, thigh and mid-upper arm circumference from baseline at 12 weeks are measured.
Time frame: Baseline and 12 weeks
Change in appetite
The changes in appetite from baseline at 12 weeks are measured.
Time frame: Baseline and 12 weeks
Change in body composition including fat percentage, muscle mass, lean body mass, bone mass and water percentage
The changes in body composition from baseline at 12 weeks are measured.
Time frame: Baseline and 12 weeks
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Change in body weight (kg)
The changes in body weight from baseline at 12 weeks are measured.
Time frame: Baseline and 12 weeks
Change in basic and active metabolic rate
The changes in BMR and AMR from baseline at 12 weeks are measured.
Time frame: Baseline and 12 weeks
Change in food intake
Change in food intake The changes in food intake (macro and micro nutrient intake) from baseline at 12 weeks are measured.
Time frame: Baseline and 12 weeks
Change in urine specific gravity
The changes in urine specific gravity from baseline at 12 weeks are measured.
Time frame: Baseline and 12 weeks