Effects of Zinc Supplementation on Anthropometric Factors, Apelin and Inflammatory Markers in Obese Individuals
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 obesity
Started Oct 2014
Shorter than P25 for phase_2 obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 30, 2015
CompletedFirst Posted
Study publicly available on registry
August 6, 2015
CompletedAugust 6, 2015
August 1, 2015
6 months
July 30, 2015
August 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
weight
15 weeks
Study Arms (2)
zinc sulfate
ACTIVE COMPARATOR1 zinc sulfate capsule for 15 weeks
starch
PLACEBO COMPARATOR1 corn starch capsule for 15 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Age of 18 to 45 years
- Non-smoking
- Body Mass Index (BMI) more than 30
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31827626DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Azita Hekmatdoost, MD,PHD
National Nutrition and Food Technology Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 30, 2015
First Posted
August 6, 2015
Study Start
October 1, 2014
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
August 6, 2015
Record last verified: 2015-08