Effect of Consumption of Caraway on Treatment of Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833377
• Other study ID #: NCT12345678
• Status: Completed
• Phase: N/A
• First received: March 26, 2013
• Last updated: April 15, 2013
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: 'MEDICAL ETHICS COMMITTEE: UNIVERSITY MALAYA MEDICAL CENTRE, KUALA LUMPUR, MALAYSIA'
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• caraway sample

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index	The changes in BMI from baseline at 12 weeks are measured.	Baseline and 12 weeks	No
Secondary	change in all blood parameters	The changes in all blood parameters from baseline at 12 weeks are measured.	Baseline and 12 weeks	Yes
Secondary	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	Yes
Secondary	Change in body weight	The changes in body weight from baseline at 12 weeks are measured.	Baseline and 12 weeks	No
Secondary	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	No
Secondary	Change in appetite	The changes in appetite from baseline at 12 weeks are measured.	Baseline and 12 weeks	No
Secondary	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	No
Secondary	Change in body weight (kg)	The changes in body weight from baseline at 12 weeks are measured.	Baseline and 12 weeks	No
Secondary	Change in basic and active metabolic rate	The changes in BMR and AMR from baseline at 12 weeks are measured.	Baseline and 12 weeks	No
Secondary	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	No
Secondary	Change in urine specific gravity	The changes in urine specific gravity from baseline at 12 weeks are measured.	Baseline and 12 weeks	Yes