Effect of Consumption of Caraway on Treatment of Obesity

University of Malaya

Status: Completed

Conditions: Overweight; Obesity

Treatments: Dietary Supplement: caraway sample; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01833377

NCT12345678

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: Female

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

caraway sample

Experimental group

Description:

caraway sample

Treatment:

Dietary Supplement: caraway sample

Placebo

Active Comparator group

Treatment:

Dietary Supplement: placebo