Effect of Consumption of Caraway on Treatment of Obesity

Study Overview
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Brief Summary
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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
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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).

Official Title
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Caraway Intake as a Sustainable Dietary Practice: Impact on Overweight & Obese Women

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Dietary Supplement: caraway sample
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: caraway sample<br>caraway sample | Dietary Supplement: caraway sample<br> <br> * Other names: caraway water extract product;|
| Active Comparator: Placebo<br> | Dietary Supplement: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index | The changes in BMI from baseline at 12 weeks are measured. | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in all blood parameters | The changes in all blood parameters from baseline at 12 weeks are measured. | 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. | Baseline and 12 weeks | 
| Change in body weight | The changes in body weight from baseline at 12 weeks are measured. | 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. | Baseline and 12 weeks | 
| Change in appetite | The changes in appetite from baseline at 12 weeks are measured. | 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. | Baseline and 12 weeks | 
| Change in body weight (kg) | The changes in body weight from baseline at 12 weeks are measured. | Baseline and 12 weeks | 
| Change in basic and active metabolic rate | The changes in BMR and AMR from baseline at 12 weeks are measured. | 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. | Baseline and 12 weeks | 
| Change in urine specific gravity | The changes in urine specific gravity from baseline at 12 weeks are measured. | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight, BMI