Effect of Consumption of Caraway on Treatment of Obesity

NCT01833377 | Completed DMC

• 1 other identifier: NCT12345678
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Overweight

Keywords

obesity; overweight; BMI

Outcome Measures

Primary Outcomes (1)

• Change in body mass index

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

  Baseline and 12 weeks

Secondary Outcomes (10)

• change in all blood parameters

  Baseline and 12 weeks

• Change in vital parameters (systolic and diastolic blood pressure and pulse rate)

  Baseline and 12 weeks

• Change in body weight

  Baseline and 12 weeks

• Change in anthropometric indices including waist, hip, thigh and mid-upper arm circumference (cm)

  Baseline and 12 weeks

• Change in appetite

  Baseline and 12 weeks

Study Arms (2)

caraway sample

EXPERIMENTAL

caraway sample

Dietary Supplement: caraway sample

Placebo

ACTIVE COMPARATOR

Dietary Supplement: placebo

Interventions

caraway sample DIETARY_SUPPLEMENT

Also known as: caraway water extract product

caraway sample

placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• overweight and obese women (BMI\> 25)
• aged 20-55 years old
• healthy subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Related Publications (2)

• 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.

  PMID: 32410532 DERIVED

• 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.

  PMID: 24319489 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• che wan jasimah mohamed radzi, PhD

  University of Malaya

  STUDY CHAIR

• Majid Hajifaraji, PhD

  Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 16, 2013
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 16, 2013

Record last verified: 2013-04