Obesity, Overweight
Conditions
Keywords
obesity, overweight, BMI
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).
Interventions
DIETARY_SUPPLEMENTcaraway sample
DIETARY_SUPPLEMENTplacebo
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass index | Baseline and 12 weeks | The changes in BMI from baseline at 12 weeks are measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in all blood parameters | Baseline and 12 weeks | The changes in all blood parameters 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 weight | Baseline and 12 weeks | The changes in body weight 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 urine specific gravity | Baseline and 12 weeks | The changes in urine specific gravity 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 body weight (kg) | Baseline and 12 weeks | The changes in body weight 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 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. |
| Change in appetite | Baseline and 12 weeks | The changes in appetite from baseline at 12 weeks are measured. |
Outcome results
None listed