Protocol summary
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Study aim
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The aim of present study is to compare the effects of high protein versus high carbohydrate intake at evening meal on glycemic control, lipid profile and oxidative stress in patients with type 2 diabetes.
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Design
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This is a 10-week single blinded, randomized controlled trial. Applying block randomization, the participants will randomly assigned to either of the following three groups: Standard evening meal, High carbohydrate evening meal and High protein evening meal. Sample size was calculated to be 30 in each group.
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Settings and conduct
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The Participants will be followed for 10 weeks, during which they visit the specially designated clinic in Shiraz city at weeks 2, 5 and 10.Body weight and waist circumference will be measured before the intervention, at week 5 and at the end of the intervention. Furthermore fasting glucose, HbA1c, insulin, lipid profile and oxidative stress will be measured at the beginning and at the end of the intervention. Fasting glucose will be also measured at week 5. Participants will be unaware of random allocation into different groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria are having type 2 diabetes; diabetes duration of 1-15 years; age of 30-65 years old; HbA1c ≤ 8%; BMI 22-35 Kg/m2; not taking insulin or α glucosidase inhibitors; weight maintenance during past 3 month; not having heart, liver, kidney, thyroid, gastrointestinal and respiratory disorders or malignancies; not consuming alcohol; not being on special diets like vegan; not being pregnant or lactating.
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Intervention groups
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In Standard evening group, protein and carbohydrate are rather evenly distributed among meals. In High carbohydrate evening meal group, 40-45% of total carbohydrate intake is provided at dinner and evening snack. In High protein evening meal group, 40-45% of total protein intake is at dinner and evening snack.
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Main outcome variables
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Hemoglobin A1c
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017042733666N1
Registration date:
2017-06-30, 1396/04/09
Registration timing:
prospective
Last update:
2019-04-01, 1398/01/12
Update count:
1
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Registration date
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2017-06-30, 1396/04/09
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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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Vice chancellery for research of Shiraz University of Medical Sciences
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Expected recruitment start date
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2017-07-01, 1396/04/10
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Expected recruitment end date
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2017-10-02, 1396/07/10
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Actual recruitment start date
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2017-07-01, 1396/04/10
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Actual recruitment end date
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2017-12-22, 1396/10/01
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Trial completion date
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2018-03-17, 1396/12/26
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Scientific title
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Comparison of the effect of high protein versus high carbohydrate intake at evening meal on glycemic control, lipid profile and oxidative stress in patients with type 2 diabetes
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Public title
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The effect of diet on diabetes management
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having type 2 diabetes mellitus according to American Diabetes Association criteria
Diabetes duration of 1-15 years
Age range of 30-65 years old
Hemoglobin A1c (HbA1c) less than or equal to 8%
Body mass index (BMI) 22- 35 kilograms per square meter
Weight maintenance (± 3 kg) during past 3 month
Stable medications during at least past two month
Willingness to participate in study
Exclusion criteria:
Not taking insulin or α glucosidase inhibitors
Not having heart, liver, kidney, thyroid, gastrointestinal and respiratory disorders or malignancies
Not consuming alcohol
Not being on special diets like gluten free or vegan
Not being pregnant or lactating
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Age
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From 30 years old to 65 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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- Participant
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
90
Actual sample size reached:
96
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants were randomly assigned into three groups using block randomization. Block size of 3 was used. To do this, first participant was assigned into the first group, second participant into the second group and third participant into the third group and the process was continued.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants were not aware of random allocation to different groups. Statistics specialist is also unaware of intervention each group received.
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Placebo
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Not used
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Assignment
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Parallel
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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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2017-04-17, 1396/01/28
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Ethics committee reference number
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IR.SUMS.REC.1396.7
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes
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ICD-10 code
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E11
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ICD-10 code description
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Non-insulin-dependent diabetes mellitus
Primary outcomes
1
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Description
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Hemoglobin A1c
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Timepoint
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The begining and the end of the stuy
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Method of measurement
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In percent by using the assay kit
Secondary outcomes
1
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Description
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Serum malondialdehyde
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Timepoint
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The begining and the end of the study
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Method of measurement
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In micromolar by using the assay kit
2
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Description
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Anthropometric measurements (body weight and waist circumference)
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Timepoint
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The begining, middle and the end of the study
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Method of measurement
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By weighting scale with accuracy of 0.1 kg and measuring tape with accuracy of 0.1 cm
3
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Description
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Lipid profile (Triglyceride, Total cholestrol, Low density lipoprotein cholestrol, High density lipoprotein cholestrol)
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Timepoint
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The begining and the end of the study
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Method of measurement
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In milligram per deciliter by using the assay kit
4
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Description
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Fasting serum insulin
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Timepoint
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The begining and the end of the study
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Method of measurement
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In picomole per liter by using the assay kit
5
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Description
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Fasting serum glucose
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Timepoint
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The begining of the study, the end of weeks 2 and 5, the end of the study
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Method of measurement
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In milligram per deciliter by using the assay kit
Intervention groups
1
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Description
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Intervention group: A 10-week diet with 40-45% of daily carbohydrate intake at evening meal and bedtime snack
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Category
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Lifestyle
2
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Description
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Intervention group: A 10-week diet with 40-45% of daily protein intake at evening meal and bedtime snack
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Category
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Lifestyle
3
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Description
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Control group: A standard diet with balanced distribution of carbohydrate, protein and fat throughout the day
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Category
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Lifestyle
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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Shiraz University of Medical Sciences
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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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Public
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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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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable