Effect of Consumption of Caraway on Treatment of Obesity

April 15, 2013 updated by: University of Malaya

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Placebo
Dietary supplement: placebo
Experimental: caraway sample
Dietary supplement: caraway sample
Other Names:
  • caraway water extract product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body mass index
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
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)
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
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)
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
The changes in body composition from baseline at 12 weeks are measured.
Baseline and 12 weeks
Change in body weight (kg)
Time Frame: Baseline and 12 weeks
The changes in body weight from baseline at 12 weeks are measured.
Baseline and 12 weeks
Change in basic and active metabolic rate
Time Frame: Baseline and 12 weeks
The changes in BMR and AMR from baseline at 12 weeks are measured.
Baseline and 12 weeks
Change in food intake
Time Frame: Baseline and 12 weeks

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
Time Frame: Baseline and 12 weeks
The changes in urine specific gravity from baseline at 12 weeks are measured.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Study Chair: che wan jasimah mohamed radzi, PhD, University of Malaya
  • Study Director: Majid Hajifaraji, PhD, Shahid Beheshti University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 26, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Estimate)

April 16, 2013

Last Update Submitted That Met QC Criteria

April 15, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT12345678

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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