DepressionNCT02362113
Glycemic Index/ Load and Mental Disorders
An observational study of Depression and Anxiety, run by Isfahan University of Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression, Anxiety, Psychological Distress
- What is being tested?
- GI/GL
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jun 2015
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Men and women aged 18-75 years of free-living individuals.
Who cannot join
- Over or underestimating of total energy intake
- Uncompleted questionnaire (more than 30% of questions)
About this study
Official title: Glycemic Index, Glycemic Load and Common Psychological Disorders
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.
Read the detailed 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.
- Conditions
- Depression, Anxiety, Psychological Distress
- Being tested
- GI/GL
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI/GLOther
GI and GL would be categorized as tertile. due to cross-sectional design of this study, intervention would not be applicable.
| Study group | Role | What they receive |
|---|---|---|
| Isfahani adults | GI/GL Receives: Other: GI/GL |
What is being measured
The primary outcome is the main question the study is designed to answer.
odds ratio for having depression resulted from statistical analysis
Measured: up to 4 months
Secondary outcomes (1)
depression score resulted from Hospital Anxiety and Depression Scale
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
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 DepressionStudies 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Azadbakht, Isfahan University of Medical Sciences
- Investigators
- Peyman Adibi, MD, Study chair, Integrative Functional Gastroenterology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362113
- Sponsor's protocol ID
- 1364
- Status last verified
- Feb 2015
- First submitted
- 2 Feb 2015
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26607943
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Index, Glycemic Load and Common Psychological Disorders
- ClinicalTrials.gov ID
- NCT02362113
- Acronym / sponsor ID
- 1364
- Conditions
- Depression, Anxiety, Psychological Distress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 12 Feb 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.
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.
Detailed 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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isfahani adults | – | Other: GI/GLGI/GL |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Men and women aged 18-75 years of free-living individuals.
Key exclusion criteria (2 listed)
- Over or underestimating of total energy intake
- Uncompleted questionnaire (more than 30% of questions)
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 |
|---|---|---|
| GI/GLGI and GL would be categorized as tertile. due to cross-sectional design of this study, intervention would not be applicable. | Other | Isfahani adults |
Primary outcome
odds ratio for having depression resulted from statistical analysis
Time frame: up to 4 months
1 secondary outcome
depression score resulted from Hospital Anxiety and Depression Scale
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
- Derived from this study: PubMed 26607943Haghighatdoost 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.
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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.
Peyman Adibi, MD study chair
Integrative Functional Gastroenterology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Isfahan University of Medical Sciences.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Feb 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
odds ratio for having depression resulted from statistical analysis (time frame: up to 4 months). 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 NCT02362113, 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 12 Feb 2015.