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Effects of zinc and vitamin D separately and in combination on mood, cortisol, tryptophan—kynurenine pathway, BDNF and hs-CRP in overweight and obese subjects

Protocol summary

Summary
Objectives: To determine effects of zinc and vitamin D separately and in combination on mood, cortisol, tryptophan—kynurenine pathway, BDNF and hs-CRP in overweight and obese subjects. Design: Randomized double-blind placebo-controlled clinical trial. Participants: overweight and obese subjects. Setting and conduct: one hundred forty eligible overweight and obese subjects will be form Iran University of Medical Sciences personnel. Thy will be randomly assigned into four groups to receive daily 2000 IU vitamin D and 30 mg zinc, 2000 IU vitamin D and zinc placebo, 30 mg zinc and vitamin D placebo either zinc and vitamin D placebo for 12 weeks. Mood will be assessed at baseline and after weeks 12. 10 cc fasting venous blood samples will be obtained at the beginning and end of intervention and serum cortisol, tryptophan, kynurenine, BDNF and hs-CRP will be measured by ELISA. In order to control confounding factors, food intakes and physical activity will be assessed before and after intervention. Intervention: 2000 IU vitamin D and 30 mg zinc or placebo. Main outcome measures: mood, serum cortisol, tryptophan, kynurenine, BDNF and hs-CRP

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201601252394N31
Registration date: 2016-10-31, 1395/08/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research,Iran University of Medical Sciences
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2017-05-01, 1396/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of zinc and vitamin D separately and in combination on mood, cortisol, tryptophan—kynurenine pathway, BDNF and hs-CRP in overweight and obese subjects
Public title
Effects of zinc and vitamin D separately and in combination on mood in overweight and obese subjects
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:age between 20 to 60 years old; BMI > 27; willing to participate; weight stable in 3 last months. Exclusion criteria: Having a history of coronary artery disease; acute or chronic renal failure; acute or chronic hepatic failure; presence of any chronic inflammatory and autoimmune disease; and any known malignancy; hormone therapy; Other non-pathological exclusion criteria included pregnancy; breast feeding; post-menopause; smoking, professional athlete; uncontrolled thyroid disorder; use of medications for dyslipidemia or hypertension; having a special diet for any reason prescribed by the clinic dietitian; consumption of nutritional supplements within the past 8 weeks.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Iran university of medical science
Street address
Iran University of Medical Sciences, Shahid Hemmet Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-06-12, 1395/03/23
Ethics committee reference number
IR.IUMS.REC 1395.9221324205

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS

Primary outcomes

1

Description
Mood
Timepoint
At baseline and after weeks 12
Method of measurement
Beck Depression Inventory

2

Description
serum cortisol
Timepoint
At baseline and after weeks 12
Method of measurement
ELISA

3

Description
serum tryptophan
Timepoint
At baseline and after weeks 12
Method of measurement
ELISA

4

Description
serum kynurenine
Timepoint
At baseline and after weeks 12
Method of measurement
ELISA

5

Description
serum BDNF
Timepoint
At baseline and after weeks 12
Method of measurement
ELISA

Secondary outcomes

1

Description
serum hs-CRP
Timepoint
At baseline and after weeks 12
Method of measurement
ELISA

Intervention groups

1

Description
vitamin D- 2000 IU /day for 12 week zinc- 30 mg/day for 12 week
Category
Treatment - Other

2

Description
zinc Placebo- 30 mg/day for 12 week vitamin D Placebo- 2000 IU/day for 12 week
Category
Placebo

3

Description
vitamin D 2000 IU/day for 12 week and zinc placebo for 12 week
Category
Treatment - Drugs

4

Description
zinc 30 mg/day 12 week and vitamin D placebo for 12 week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Science
Full name of responsible person
Somaye Yosaee
Street address
Tehran, Hemat Pathway, Iran University of Medical Science
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Science
Full name of responsible person
Dr. Seyed Ali Javad Moosavi
Street address
Iran University of Medical Sciences, Next to the Milad Hospital, Between the Intersection of Sheikh Fazlollah Noori and Chamran, Hemmat Highway
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Iran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Nutrition, School of public Health, Iran University of Medical Sciences
Full name of responsible person
Somaye Yosaee
Position
ph.D Candidate
Other areas of specialty/work
Street address
Iran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8670 4805
Fax
Email
s_yousai2006@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Nutrition, School of public Health, Iran University of Medical Sciences
Full name of responsible person
Dr. Shima Jazayeri
Position
MD, PhD /Assistant Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran. Tehran
City
Tehran
Postal code
Phone
+98 21 8670 4805
Fax
Email
sh_jazayeri@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somaye Yosaee
Position
ph.D candidate
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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