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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| caraway sample | Experimental | caraway sample |
|
| Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caraway sample | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index | The changes in BMI from baseline at 12 weeks are measured. | Baseline and 12 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| che wan jasimah mohamed radzi, PhD | University of Malaya | Study Chair |
| Majid Hajifaraji, PhD | Shahid Beheshti University of Medical Sciences | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32410532 | Derived | Kazemipoor M, Rezaeian M, Kazemipoor M, Hamzah S, Shandilya SK. Computational Intelligence Techniques for Assessing Anthropometric Indices Changes in Female Athletes. Curr Med Imaging. 2020;16(4):288-295. doi: 10.2174/1573405614666180905111814. | |
| 24319489 | Derived | Kazemipoor M, Radzi CW, Hajifaraji M, Haerian BS, Mosaddegh MH, Cordell GA. Antiobesity effect of caraway extract on overweight and obese women: a randomized, triple-blind, placebo-controlled clinical trial. Evid Based Complement Alternat Med. 2013;2013:928582. doi: 10.1155/2013/928582. Epub 2013 Nov 10. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| placebo |
| Dietary Supplement |
|
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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |