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

NCT ID: NCT02516475

Last Updated: 2015-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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zinc sulfate

1 zinc sulfate capsule for 15 weeks

Group Type ACTIVE_COMPARATOR

zinc sulfate

Intervention Type DIETARY_SUPPLEMENT

1 zinc sulfate capsule for 15 weeks

starch

1 corn starch capsule for 15 weeks

Group Type PLACEBO_COMPARATOR

corn starch

Intervention Type OTHER

1 corn starch capsule for 15 weeks

Interventions

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zinc sulfate

1 zinc sulfate capsule for 15 weeks

Intervention Type DIETARY_SUPPLEMENT

corn starch

1 corn starch capsule for 15 weeks

Intervention Type OTHER

Other Intervention Names

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placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Azita Hekmatdoost

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Azita Hekmatdoost, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

National Nutrition and Food Technology Research Institute

References

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Khorsandi H, Nikpayam O, Yousefi R, Parandoosh M, Hosseinzadeh N, Saidpour A, Ghorbani A. Zinc supplementation improves body weight management, inflammatory biomarkers and insulin resistance in individuals with obesity: a randomized, placebo-controlled, double-blind trial. Diabetol Metab Syndr. 2019 Dec 2;11:101. doi: 10.1186/s13098-019-0497-8. eCollection 2019.

Reference Type DERIVED
PMID: 31827626 (View on PubMed)

Other Identifiers

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055570

Identifier Type: -

Identifier Source: org_study_id

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