- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02516475
Effects of Zinc Supplementation on Anthropometric Factors, Apelin and Inflammatory Markers in Obese Individuals
August 3, 2015 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
Effects of Zinc Supplementation on Weight, Body Mass Index (BMI), Waist Circumference, Fat Mass and Lean Mass, Apelin and Inflammatory Markers in Obese Individuals
To study the effects of zinc supplement on anthropometric factors, Apelin and inflammatory markers in obese individuals, 50 obes person who referred to Diet and Nutrition clinic of Shahid Beheshti University of Medical Sciences will be randomly allocated to receive 50 mg zinc capsules or placebos for 15 weeks; both groups will be advised to adherence the investigators' diet .
At the first and the end of the intervention,weight, body mass index (BMI), waist circumference, fat mass and lean body mass, concentration of zinc, albumin, hs-CRP, TNF-α and plasma apelin will be assessed and compared between groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
- Phase 3
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age of 18 to 45 years
- Non-smoking
- Body Mass Index (BMI) more than 30
Exclusion Criteria:
- Pregnancy, lactation or menopause in women
- History of liver disease, kidney, thyroid, diabetes and other metabolic diseases
- Use of drugs interfering with lipid profile, blood-thinning drugs, beta-blockers
- Patients with immune deficiency
- Use of zinc, calcium and iron supplement in the last 2 months
- Use of weight loss medication or special diet
- Following program to lose weight in recent 2 months
- Recent surgery
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: zinc sulfate
1 zinc sulfate capsule for 15 weeks
|
1 zinc sulfate capsule for 15 weeks
|
Placebo Comparator: starch
1 corn starch capsule for 15 weeks
|
1 corn starch capsule for 15 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weight
Time Frame: 15 weeks
|
15 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Azita Hekmatdoost, MD,PHD, National Nutrition and Food Technology Research Institute
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.
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
October 1, 2014
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
July 30, 2015
First Submitted That Met QC Criteria
August 3, 2015
First Posted (Estimate)
August 6, 2015
Study Record Updates
Last Update Posted (Estimate)
August 6, 2015
Last Update Submitted That Met QC Criteria
August 3, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 055570
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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