Clinical trial NCT01833377: Effect of Consumption of Caraway on Treatment of Obesity
Official title: Caraway Intake as a Sustainable Dietary Practice: Impact on Overweight & Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: obesity
overweight
BMI
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in body mass index
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: change in all blood parameters
timeFrame: Baseline and 12 weeks
measure: Change in vital parameters (systolic and diastolic blood pressure and pulse rate)
timeFrame: Baseline and 12 weeks
measure: Change in body weight
timeFrame: Baseline and 12 weeks
measure: Change in anthropometric indices including waist, hip, thigh and mid-upper arm circumference (cm)
timeFrame: Baseline and 12 weeks
measure: Change in appetite
timeFrame: Baseline and 12 weeks
measure: Change in body composition including fat percentage, muscle mass, lean body mass, bone mass and water percentage
timeFrame: Baseline and 12 weeks
measure: Change in body weight (kg)
timeFrame: Baseline and 12 weeks
measure: Change in basic and active metabolic rate
timeFrame: Baseline and 12 weeks
measure: Change in food intake
timeFrame: Baseline and 12 weeks
measure: Change in urine specific gravity
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Malaya
name: che wan jasimah mohamed radzi, PhD
role: STUDY_CHAIR
affiliation: Shahid Beheshti University of Medical Sciences
name: Majid Hajifaraji, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.