Protocol summary
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Study aim
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The aim of this study was to compare the effect of high protein versus high carbohydrate intake at evening meal on quality of life, sleep quality and inflammation 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 were 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 with attrition rate of 20%.
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Settings and conduct
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The Participants were followed for 10 weeks, during which they visited the specially designated clinic in Shiraz city at weeks 2, 5 and 10. Anthropometric measurements and blood pressure were monitored at weeks 0, 5 and 10. Inflammatory marker hs-CRP was measured at the beginning and at the end of the study. Quality of life and sleep quality questionnaires were filled by the participants at weeks 0, 5 and 10. Participants were unaware of random allocation into different groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria were type 2 diabetes; hemoglobin A1c equal or less than 8%; body mass index equal or greater than 22 and less than 35 kilograms per square meter; not taking insulin or α glucosidase inhibitors; not having heart, liver, kidney, thyroid, gastrointestinal and respiratory disorders or malignancies; not being pregnant or lactating.
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Intervention groups
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In Standard evening group, protein and carbohydrate were rather evenly distributed among meals. In High carbohydrate evening meal group, 40-45% of total carbohydrate intake was provided at dinner and evening snack. In High protein evening meal group, 40-45% of total protein intake was at dinner and evening snack.
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Main outcome variables
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Main outcome of current study was change in quality of life of study participants.
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:
IRCT20170427033666N2
Registration date:
2018-11-22, 1397/09/01
Registration timing:
retrospective
Last update:
2020-10-19, 1399/07/28
Update count:
2
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Registration date
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2018-11-22, 1397/09/01
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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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2018-05-05, 1397/02/15
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Expected recruitment end date
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2018-05-20, 1397/02/30
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Actual recruitment start date
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2018-04-29, 1397/02/09
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Actual recruitment end date
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2018-05-05, 1397/02/15
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Trial completion date
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2018-08-06, 1397/05/15
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Scientific title
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Effect of high protein versus high carbohydrate intake at evening meal on quality of life, sleep quality and inflammation in patients with type 2 diabetes
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Public title
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The effect of diet on quality of life and sleep quality of patients with diabetes
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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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2018-04-29, 1397/02/09
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Ethics committee reference number
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IR.SUMS.REC.1397.101
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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E 11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Quality of life
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Timepoint
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The beginning, middle and the end of the study
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Method of measurement
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Questionnaire
Secondary outcomes
1
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Description
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Sleep quality
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Timepoint
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The beginning, middle and the end of the study
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: A 10-week diet in which 40-45% of total carbohydrate intake was provided at dinner and evening 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-weeks diet in which 40-45% of total protein intake was at dinner and evening snack.
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Category
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Lifestyle
3
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Description
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Control group: A 10-weeks diet in which protein and carbohydrate were rather evenly distributed among meals.
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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I have no plan to share it.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable