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Effects of Zinc Supplementation on Anthropometric Factors, Apelin and Inflammatory Markers in Obese Individuals

Sponsor
National Nutrition and Food Technology Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02516475
Collaborator
(none)
50
Enrollment
2
Arms
8
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: zinc sulfate
  • Other: corn starch
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Zinc Supplementation on Weight, Body Mass Index (BMI), Waist Circumference, Fat Mass and Lean Mass, Apelin and Inflammatory Markers in Obese Individuals
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: zinc sulfate

1 zinc sulfate capsule for 15 weeks

Dietary Supplement: zinc sulfate
1 zinc sulfate capsule for 15 weeks
Placebo Comparator: starch

1 corn starch capsule for 15 weeks

Other: corn starch
1 corn starch capsule for 15 weeks
Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. weight [15 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Nutrition and Food Technology Institute

    Investigators

    • Principal Investigator: Azita Hekmatdoost, MD,PHD, National Nutrition and Food Technology Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Azita Hekmatdoost, Principal Investigator, National Nutrition and Food Technology Institute
    ClinicalTrials.gov Identifier:
    NCT02516475
    Other Study ID Numbers:
    • 055570
    First Posted:
    Aug 6, 2015
    Last Update Posted:
    Aug 6, 2015
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Zinc Sulfate

    Study Results

    No Results Posted as of Aug 6, 2015