- Objective: To determine the effects of Crocus sativus L. supplementation on weight and depression among overweight women with depression compared with the control group. - Main inclusion criteria: Age 18 to 50 years, female gender, body mass index above 25, the diagnosis of depression - Main exclusion criteria: Taking drugs that affect on depression and weight, hormonal and metabolic disorders - Study population: The 18-50 years women with depression who are overweight or obese - Sample size: 50 - Intervention Study: Crocus sativus L. - Intervention duration: 12 weeks - Primary outcome or outcomes studied: Depression, weight, body mass index - Design of the study: fifty patients with mild depression (based on a semi-structured diagnostic interview and the Hamilton depression scale test) who are overweight or obese will participate in this double-blind, 12-week, placebo-controlled study. Participants will sign the informed consent form and then they will be randomly assigned to one of two groups receiving daily 30 mg of Crocus sativus L. capsules or placebo. The groups will be blinded by placebo to participants and will be blinded to researcher by coding. At the end, hypothesis of the study will be tested.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041916465N2
Registration date:2014-06-16, 1393/03/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-06-16, 1393/03/26
Registrant information
Name
Seyed-Ali Mostafavi
Name of organization / entity
Psychiatry Research Center/ Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 2002
Email address
mostafavi_a@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2016-03-18, 1394/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Crocus sativus L. supplementation on weight and depression among overweight women with depression compared with the placebo
Public title
Evaluating the effects of Crocus sativus L. (Saffron) on weight and depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 to 50 years; females; Body Mass Index above 25; patients with mild (minor) depression based on semi- structured diagnostic interview by a psychiatrist; to sign a consent form
Exclusion Criteria: Those who are taking antidepressants; severe (major) depression; psychotic depression or have suicidal thoughts; use of anti-inflammatory glucocorticoids, and steroids; those who take medicines to reduce appetite or weight; those with diabetes who are taking medications or insulin; those with heart disease or hypercholesterolemia who are taking medication (statins, fibrates, diuretics); those how are taking oral anti-inflammatory drugs corticosteroids or any drug that causes weight loss or gain; taking hormonal contraceptives; pregnancy and lactation; menopause; severe mental disorder; schizophrenia and bipolar; hypothyroidism; exercise professionals; those with special diets such as the diets for kidney disorders.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Committee on Ethics in Medical Research, Research Council, Central Building of Tehran University of Medical Sciences, Keshavarz Blvd Tehran, Iran
City
Tehran
Postal code
Approval date
2013-12-05, 1392/09/14
Ethics committee reference number
130/2045/د/92
Health conditions studied
1
Description of health condition studied
Mild Depression
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode Two or three of the above symptoms are usually present. The patient is usually distressed by these but will probably be able to continue with most activities.
2
Description of health condition studied
Moderate depression
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode Four or more of the above symptoms are usually present and the patient is likely to have great difficulty in continuing with ordinary activities.
3
Description of health condition studied
Obseity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Weight
Timepoint
At baseline and at weeks 2, 4, 8 and 12 after the bigining of the study
Method of measurement
Standard scales Seca
2
Description
Body Mass Index
Timepoint
At baseline and at weeks 2, 4, 8 and 12 after the bigining of the study
Method of measurement
kg/(m)2
3
Description
Depression
Timepoint
At baseline and at weeks 2, 4, 8 and 12 after the bigining of the study
Method of measurement
Hamilton rating scale for depression
Secondary outcomes
empty
Intervention groups
1
Description
30 mg Crocus sativus L. capsules for 12 weeks
Category
Treatment - Drugs
2
Description
Placebo capsule for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Private weight loss clinic
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Harati-Zadeh
Street address
No. 608, Research Coordination Centre Office, Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Psychiatric Research Center
Full name of responsible person
Seyed-Ali Mostafavi
Position
Ph.D by Research student
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar St.
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
mostafavi.n80@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Psychiatric Research Center
Full name of responsible person
Shahin Akhondzadeh
Position
Ph.D
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar St.
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
s.akhond@neda.net
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Psychiatric Research Center
Full name of responsible person
Seyed-Ali Mostafavi
Position
Ph.D by Research student
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar St.
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
mostafavi.n80@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)