NCT02362113

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

February 2, 2015

Last Update Submit

February 7, 2015

Conditions

DepressionAnxietyPsychological Distress

Outcome Measures

Primary Outcomes (1)

  • odds ratio for having depression resulted from statistical analysis

    up to 4 months

Secondary Outcomes (1)

  • depression score resulted from Hospital Anxiety and Depression Scale

    up to 6 months

Study Arms (1)

Isfahani adults

GI/GL

Other: GI/GL

Interventions

GI/GLOTHER

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

Isfahani adults

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

non-academic staff of Isfahan University of Medical Sciences (IUMS), Isfahan, Iran, who were working in hospitals, university campus and health centers affiliated with IUMS

You may qualify if:

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

You may not qualify if:

  • Over or underestimating of total energy intake
  • Uncompleted questionnaire (more than 30% of questions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Haghighatdoost F, Azadbakht L, Keshteli AH, Feinle-Bisset C, Daghaghzadeh H, Afshar H, Feizi A, Esmaillzadeh A, Adibi P. Glycemic index, glycemic load, and common psychological disorders. Am J Clin Nutr. 2016 Jan;103(1):201-9. doi: 10.3945/ajcn.114.105445. Epub 2015 Nov 25.

    PMID: 26607943DERIVED

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Peyman Adibi, MD

    Integrative Functional Gastroenterology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Community Nutrition, School of Nutrition and Food Science

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 12, 2015

Study Start

December 1, 2014

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

February 12, 2015

Record last verified: 2015-02