ObesityPhase 2/3NCT02516475
Effects of Zinc Supplementation on Anthropometric Factors, Apelin and Inflammatory Markers in Obese Individuals
A Phase 2/3 study testing zinc sulfate and corn starch in people with Obesity, run by National Nutrition and Food Technology Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- zinc sulfate and corn starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Jun 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 18 to 45 years
- Non-smoking
- Body Mass Index (BMI) more than 30
Who cannot join
- 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
About this study
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
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.
- Conditions
- Obesity
- Being tested
- zinc sulfate, corn starch
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc sulfateDietary supplement
1 zinc sulfate capsule for 15 weeks
corn starchOther
Also called placebo
1 corn starch capsule for 15 weeks
| Study group | Role | What they receive |
|---|---|---|
| zinc sulfate | Active comparator | 1 zinc sulfate capsule for 15 weeks Receives: Dietary Supplement: zinc sulfate |
| starch | Placebo comparator | 1 corn starch capsule for 15 weeks Receives: Other: corn starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
- Investigators
- Azita Hekmatdoost, MD,PHD, Principal investigator, National Nutrition and Food Technology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516475
- Sponsor's protocol ID
- 055570
- Status last verified
- Aug 2015
- First submitted
- 30 Jul 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31827626
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02516475
- Acronym / sponsor ID
- 055570
- Conditions
- Obesity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zinc sulfate | Active comparator | Dietary Supplement: zinc sulfate1 zinc sulfate capsule for 15 weeks |
| starch | Placebo comparator | Other: corn starch1 corn starch capsule for 15 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of 18 to 45 years
- Non-smoking
- Body Mass Index (BMI) more than 30
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc sulfate1 zinc sulfate capsule for 15 weeks | Dietary supplement | zinc sulfate |
| corn starchAlso: placebo1 corn starch capsule for 15 weeks | Other | starch |
Primary outcome
weight
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Derived from this study: PubMed 31827626Khorsandi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azita Hekmatdoost, MD,PHD principal investigator
National Nutrition and Food Technology Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing zinc sulfate and corn starch in people with Obesity, run by National Nutrition and Food Technology Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02516475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.