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
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. This study is a randomized controlled trial (parallel design) with study duration of 10 weeks. One hundred and thirty five patients with type 2 diabetes mellitus who have hemoglobin A1c (HbA1c) less than or equal to 8% and do not take insulin or α glucosidase inhibitors will be recruited by convenience sampling. Then they will be randomly assigned into three groups of “standard evening meal”, “high protein evening meal” and “high carbohydrate evening meal” and receive their respective diets. In “standard evening meal” group; carbohydrate, protein and fat have a balanced distribution among meals while in “high carbohydrate evening meal” group 40-45% of daily carbohydrate intake and in “high protein evening meal” group, 40-45% of daily protein intake will be allocated to evening meal and bedtime snack. Participants with poor dietary adherence will be excluded from the study. 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 weeks 2 and 5.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042733666N1
Registration date:2017-06-30, 1396/04/09
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Fatemeh Nouripour
Name of organization / entity
Shiraz Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1007
Email address
nouripourf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for research of Shiraz University of Medical Sciences
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2017-10-02, 1396/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of diet on diabetes management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are 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) less than 35 kilograms per square meter; not taking insulin or α glucosidase inhibitors; weight maintenance (± 3 kg) 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 gluten free or vegan; not being pregnant or lactating ; and willingness to participate in study. Exclusion criteria are unwillingness to continue participating in study, poor dietary adherence and any change in medications or physical activity level during study.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Postal code
14336 - 71348
Approval date
2017-04-17, 1396/01/28
Ethics committee reference number
IR.SUMS.REC.1396.7
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Hemoglobin A1c
Timepoint
The begining and the end of the stuy
Method of measurement
In percent by using the assay kit
Secondary outcomes
1
Description
Serum malondialdehyde
Timepoint
The begining and the end of the study
Method of measurement
In micromolar by using the assay kit
2
Description
Anthropometric measurements (body weight and waist circumference)
Timepoint
The begining, middle and the end of the study
Method of measurement
By weighting scale with accuracy of 0.1 kg and measuring tape with accuracy of 0.1 cm
3
Description
Lipid profile (Triglyceride, Total cholestrol, Low density lipoprotein cholestrol, High density lipoprotein cholestrol)
Timepoint
The begining and the end of the study
Method of measurement
In milligram per deciliter by using the assay kit
4
Description
Fasting serum insulin
Timepoint
The begining and the end of the study
Method of measurement
In picomole per liter by using the assay kit
5
Description
Fasting serum glucose
Timepoint
The begining of the study, the end of weeks 2 and 5, the end of the study
Method of measurement
In milligram per deciliter by using the assay kit
Intervention groups
1
Description
Intervention group: A 10-week diet with 40-45% of daily carbohydrate intake at evening meal and bedtime snack
Category
Lifestyle
2
Description
Intervention group: A 10-week diet with 40-45% of daily protein intake at evening meal and bedtime snack
Category
Lifestyle
3
Description
Control group: A standard diet with balanced distribution of carbohydrate, protein and fat throughout the day
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic
Full name of responsible person
Fatemeh Nouripour
Street address
Namazi Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for research of Shiraz University of Medical Sciences
Full name of responsible person
Kambiz Eskandari
Street address
Central building of Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research of Shiraz University of Medical Sciences