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Effect of Consumption of Caraway on Treatment of Obesity

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
caraway sample
placebo
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, overweight, BMI

Eligibility Criteria

20 Years - 55 Years (Adult)FemaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    caraway sample

    Placebo

    Arm Description

    caraway sample

    Outcomes

    Primary Outcome Measures

    Change in body mass index
    The changes in BMI from baseline at 12 weeks are measured.

    Secondary Outcome Measures

    change in all blood parameters
    The changes in all blood parameters from baseline at 12 weeks are measured.
    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.
    Change in body weight
    The changes in body weight from baseline at 12 weeks are measured.
    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.
    Change in appetite
    The changes in appetite from baseline at 12 weeks are measured.
    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.
    Change in body weight (kg)
    The changes in body weight from baseline at 12 weeks are measured.
    Change in basic and active metabolic rate
    The changes in BMR and AMR from baseline at 12 weeks are measured.
    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.
    Change in urine specific gravity
    The changes in urine specific gravity from baseline at 12 weeks are measured.

    Full Information

    First Posted
    March 26, 2013
    Last Updated
    April 15, 2013
    Sponsor
    University of Malaya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01833377
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Malaya

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Overweight
    Keywords
    obesity, overweight, BMI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    caraway sample
    Arm Type
    Experimental
    Arm Description
    caraway sample
    Arm Title
    Placebo
    Arm Type
    Active Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    caraway sample
    Other Intervention Name(s)
    caraway water extract product
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    Change in body mass index
    Description
    The changes in BMI from baseline at 12 weeks are measured.
    Time Frame
    Baseline and 12 weeks
    Secondary Outcome Measure Information:
    Title
    change in all blood parameters
    Description
    The changes in all blood parameters from baseline at 12 weeks are measured.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in vital parameters (systolic and diastolic blood pressure and pulse rate)
    Description
    The changes in systolic and diastolic blood pressure and pulse rate from baseline at 12 weeks are measured.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in body weight
    Description
    The changes in body weight from baseline at 12 weeks are measured.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in anthropometric indices including waist, hip, thigh and mid-upper arm circumference (cm)
    Description
    The changes in anthropometric indices including waist, hip, thigh and mid-upper arm circumference from baseline at 12 weeks are measured.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in appetite
    Description
    The changes in appetite from baseline at 12 weeks are measured.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in body composition including fat percentage, muscle mass, lean body mass, bone mass and water percentage
    Description
    The changes in body composition from baseline at 12 weeks are measured.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in body weight (kg)
    Description
    The changes in body weight from baseline at 12 weeks are measured.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in basic and active metabolic rate
    Description
    The changes in BMR and AMR from baseline at 12 weeks are measured.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in food intake
    Description
    Change in food intake The changes in food intake (macro and micro nutrient intake) from baseline at 12 weeks are measured.
    Time Frame
    Baseline and 12 weeks
    Title
    Change in urine specific gravity
    Description
    The changes in urine specific gravity from baseline at 12 weeks are measured.
    Time Frame
    Baseline and 12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    che wan jasimah mohamed radzi, PhD
    Organizational Affiliation
    University of Malaya
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Majid Hajifaraji, PhD
    Organizational Affiliation
    Shahid Beheshti University of Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32410532
    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.
    Results Reference
    derived
    PubMed Identifier
    24319489
    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.
    Results Reference
    derived

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    Effect of Consumption of Caraway on Treatment of Obesity

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