Glycemic Index/ Load and Mental Disorders

Depression Clinical Trial

Official title:

Glycemic Index, Glycemic Load and Common Psychological Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02362113
• Other study ID #: 1364
• Status: Active, not recruiting
• Phase: N/A
• First received: February 2, 2015
• Last updated: February 7, 2015
• Start date: December 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2015
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Observational

Clinical Trial Summary

A total of 300 adults would be included in the present cross-sectional study. glycemic index (GI) and glycemic load (GL) would be assessed by using a validated self-administered dish-based semi-quantitative food frequency questionnaire. Validated Iranian versions of Hospital Anxiety and Depression Scale and General Health Questionnaire-12 would be used to assess anxiety, depression and psychological distress.

Description:

Frequency of 5 food groups will be asked in dish-based semi-quantitative food frequency questionnaire and they would be converted to grams. GI and GL will be estimated by using international table of GI and GL.

Validated Iranian versions of Hospital Anxiety and Depression Scale and General Health Questionnaire (GHQ)-12 were used to assess anxiety, depression and psychological distress.

Possible score range for anxiety and depression is from 0 to 21. Scores of 8 or higher on either section were considered as the presence of anxiety or depression and scores of 7 or less were considered as normal status. In the present study, participants who got scores of 4 or more from GHQ were considered to have psychological distress.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men and women aged 18-75 years of free-living individuals.

Exclusion Criteria:

• Over or underestimating of total energy intake

• Uncompleted questionnaire (more than 30% of questions)

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Distress

Intervention

Other:
• GI/GL
GI and GL would be categorized as tertile. due to cross-sectional design of this study, intervention would not be applicable.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	odds ratio for having depression resulted from statistical analysis		up to 4 months	Yes
Secondary	depression score resulted from Hospital Anxiety and Depression Scale		up to 6 months	Yes