Protocol summary
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Study aim
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Investigating the effectiveness of consuming semi-prepared natural parsley soup on blood glucose and lipids in diabetic patients
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Design
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Crossover clinical trial with a control group, randomized on 28 type 2 diabetic patients in two periods of 8 weeks.
Intervention group: Semi ready parsley soup
Control group: There is no intervention
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Settings and conduct
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28 type 2 diabetic patients with a lipid profile higher than the normal range, with medical records and being treated and covered by the Yazd Diabetes Center, will be included in the study. Then the volunteers are randomly divided into two equal intervention and control groups. In the first stage, the participants in the intervention group eat the soup twice a day (morning and night) for 8 weeks. No intervention will be done in the control group. After 8 weeks, we change the places of the two groups. That is, the group that received soup in the first stage will not receive soup in the second stage, but the other group will receive soup. This process also continues for 8 weeks, it is recommended that both study groups be under the supervision of a physician in terms of medication regimen. Also, do not change your usual diet and physical activity level during the study period. At the beginning, at the end of week 8 and at the end of week 16, weight, height, blood pressure, HbA1c and blood lipid profile (T.G, CHOL) of both test groups will be measured.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age over 18 years of both gender
A1c≤8
A resident of Yazd
Exclusion criteria:
Hyperthyroidism or hypothyroidism
A1c>8
Severe liver disorders
Severe kidney disorders
Advanced heart failure
Severe pulmonary disease
Immune system deficiency diseases
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Intervention groups
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Intervention group: Semi ready parsley soup
Control group: There is no intervention
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Main outcome variables
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HbA1c
General information
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Reason for update
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Changing the study method
Changing the sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160221026684N6
Registration date:
2024-04-21, 1403/02/02
Registration timing:
prospective
Last update:
2024-07-04, 1403/04/14
Update count:
1
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Registration date
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2024-04-21, 1403/02/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-07-06, 1403/04/16
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Expected recruitment end date
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2024-11-01, 1403/08/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effectiveness of consuming semi-prepared natural parsley soup on blood glucose and lipids in diabetic patients
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Public title
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Effect of parsley soup in treatment of diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age over 18 years of both gender
A1c≤8
A resident of Yazd
Exclusion criteria:
Hyperthyroidism or hypothyroidism
A1c>8
Severe liver disorders
Severe kidney disorders
Advanced heart failure
Severe pulmonary disease
Immune system deficiency diseases
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
28
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, 28 patients with type 2 diabetes and meeting the inclusion criteria will be selected through available sampling. After determining all the samples, the patients will be randomly divided into two intervention and control groups.
Intervention allocation or random allocation is in the form of a closed envelope that the individual chooses before entering the researcher's room. The envelope with the letter A will be the intervention group and B will be the control group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-01-17, 1402/10/27
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Ethics committee reference number
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IR.SSU.REC.1402.120
Health conditions studied
1
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Description of health condition studied
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Diabetes
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ICD-10 code
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E08
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ICD-10 code description
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Diabetes mellitus due to underlying condition
Primary outcomes
1
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Description
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HbA1c
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Timepoint
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At the beginning of the study, at the end of week 8 and at the end of week 16
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Method of measurement
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Chromatography (HPLC)
Secondary outcomes
1
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Description
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Serum triglyceride level
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Timepoint
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At the beginning of the study, at the end of week 8 and at the end of week 16
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Method of measurement
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Enzymatic method
2
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Description
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Serum total cholesterol level
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Timepoint
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At the beginning of the study, at the end of week 8 and at the end of week 16
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Method of measurement
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Enzymatic method
Intervention groups
1
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Description
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Intervention group: Semi ready parsley soup: This soup is prepared and packed in 75 gram packets containing wheat semolina, parsley, lemon powder, olive oil, salt and turmeric in "Mahnam" food industry located in Karaj. Also, this soup is consumed twice a day for 2 months.
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Category
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Treatment - Other
2
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Description
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Control group: There is no intervention
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Behdane Baran Salem Abi
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Data on the main outcome will be made available to other researchers
with the permission of the first executor
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When the data will become available and for how long
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starting 6 months after publication
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To whom data/document is available
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people working in academic institutions
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Under which criteria data/document could be used
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Coordinate with project analyzer
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From where data/document is obtainable
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Dr Seyed Ali Khodaie :03537280215 dr.seyedalikhodaie@yahoo.com
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What processes are involved for a request to access data/document
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Request data from Yazd University of Medical Sciences, Consent of the Research Assistant of the Diabetes Research Center, approval of the first executor of the project
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Comments
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