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Completed

NCT Number: NCT01833377

Effect of Consumption of Caraway on Treatment of Obesity

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

caraway sample

Dietary Supplement

Other names: caraway water extract product

Placebo

Dietary Supplement

Primary outcomes

  1. Change in body mass index

    Time frame: Baseline and 12 weeks

    The changes in BMI from baseline at 12 weeks are measured.

Secondary outcomes

  1. change in all blood parameters

    Time frame: Baseline and 12 weeks

    The changes in all blood parameters from baseline at 12 weeks are measured.

  2. 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.

  3. Change in body weight

    Time frame: Baseline and 12 weeks

    The changes in body weight from baseline at 12 weeks are measured.

  4. 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.

  5. Change in appetite

    Time frame: Baseline and 12 weeks

    The changes in appetite from baseline at 12 weeks are measured.

  6. 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.

  7. Change in body weight (kg)

    Time frame: Baseline and 12 weeks

    The changes in body weight from baseline at 12 weeks are measured.

  8. 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.

  9. 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.

  10. Change in urine specific gravity

    Time frame: Baseline and 12 weeks

    The changes in urine specific gravity from baseline at 12 weeks are measured.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 16, 2013
Registry last updated
Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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