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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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History
# Registration date Revision Id
3 2020-10-16, 1399/07/25 155386
2 2019-06-27, 1398/04/06 100507
1 2018-11-22, 1397/09/01 67906
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  • Protocol summary

    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 24 in each group.
    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%.
    این مطالعه یک کار آزمایی کنترل شده تصادفی یک سو کور با طول مدت مداخله 10 هفته می باشد. شرکت کنندگان با استفاده از تصادفی سازی بلوکی به یکی از این سه گروه تقسیم بندی شدند: گروه دریافت کننده وعده شام استاندارد، گروه دریافت کننده وعده شام با کربوهیدرات بالا و گروه دریافت کننده وعده شام با پروتئین بالا. حجم نمونه مورد نیاز جهت انجام این مطالعه 24 نفر در هر گروه محاسبه گردید.
    این مطالعه یک کار آزمایی کنترل شده تصادفی یک سو کور با طول مدت مداخله 10 هفته می باشد. شرکت کنندگان با استفاده از تصادفی سازی بلوکی به یکی از این سه گروه تقسیم بندی شدند: گروه دریافت کننده وعده شام استاندارد، گروه دریافت کننده وعده شام با کربوهیدرات بالا و گروه دریافت کننده وعده شام با پروتئین بالا. حجم نمونه مورد نیاز جهت انجام این مطالعه با احتساب 20 درصد ریزش 30 نفر در هر گروه محاسبه گردید.

  • General information

    115
    96
    2017-07-01, 1396/04/10
    2018-05-05, 1397/02/15
    2017-10-02, 1396/07/10
    2018-05-20, 1397/02/30
    2017-07-01, 1396/04/10
    2018-04-29, 1397/02/09
    2017-12-22, 1396/10/01
    2018-05-05, 1397/02/15
    2018-03-17, 1396/12/26
    2018-08-06, 1397/05/15

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh Nouripour
    Full name of responsible person - Persian: فاطمه نوری پور
    Position - English: کارشناس ارشد تغذیه
    Position - Persian: Master of science in nutrition
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of nutrition and food sciences, Razi Blvd
    Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی School of nutrition and food sciences, Razi Blvd
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7153675541
    Phone: +98 71 3725 1007
    Mobile: +98 917 588 1726
    Fax:
    Email: nouripourf@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh Nouripour
    Full name of responsible person - Persian: فاطمه نوری پور
    Position - English: کارشناس ارشد تغذیه
    Position - Persian: Master of science in nutrition
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of nutrition and food sciences, Razi Blvd
    Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی School of nutrition and food sciences, Razi Blvd
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7153675541
    Phone: +98 71 3725 1007
    Mobile: +98 0000000000
    Fax:
    Email: nouripourf@sums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh Nouripour
    Full name of responsible person - Persian: فاطمه نوری پور
    Position - English: Master of science in nutrition
    Position - Persian: کارشناس ارشدتغذیه
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of nutrition and food sciences, Razi Blvd
    Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7153675541
    Phone: +98 71 3725 1007
    Mobile: +98 917 588 1726
    Fax:
    Email: nouripourf@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh Nouripour
    Full name of responsible person - Persian: فاطمه نوری پور
    Position - English: Master of science in nutrition
    Position - Persian: کارشناس ارشدتغذیه
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of nutrition and food sciences, Razi Blvd
    Street address - Persian: بولوار رازی، دانشکده تغذیه و علوم غذایی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7153675541
    Phone: +98 71 3725 1007
    Mobile: +98 0000000000
    Fax:
    Email: nouripourf@sums.ac.ir
    Web page address:

Protocol summary

Study aim
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.
Design
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%.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Main outcome of current study was change in quality of life of study participants.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170427033666N2
Registration date: 2018-11-22, 1397/09/01
Registration timing: retrospective

Last update: 2019-08-17, 1398/05/26
Update count: 2
Registration date
2018-11-22, 1397/09/01
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
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
2018-04-29, 1397/02/09
Actual recruitment end date
2018-05-05, 1397/02/15
Trial completion date
2018-08-06, 1397/05/15
Scientific title
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
Public title
The effect of diet on quality of life and sleep quality of patients with diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Actual sample size reached: 96
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were not aware of random allocation to different groups. Statistics specialist is also unaware of intervention each group received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand st
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.SUMS.REC.1397.101

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E 11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Quality of life
Timepoint
The beginning, middle and the end of the study
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Sleep quality
Timepoint
The beginning, middle and the end of the study
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: A 10-week diet in which 40-45% of total carbohydrate intake was provided at dinner and evening snack.
Category
Lifestyle

2

Description
Intervention group: A 10-weeks diet in which 40-45% of total protein intake was at dinner and evening snack.
Category
Lifestyle

3

Description
Control group: A 10-weeks diet in which protein and carbohydrate were rather evenly distributed among meals.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahhari Diabetes Clinic
Full name of responsible person
Fatemeh Nouripour
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7166776770
Phone
+98 71 3612 1000
Email
nouripourf@sums.ac.ir

2

Recruitment center
Name of recruitment center
Hakim Diabetes Clinic
Full name of responsible person
Fatemeh Nouripour
Street address
Farhang Shahr
City
Shiraz
Province
Fars
Postal code
0000000000
Phone
+98 71 3632 5816
Email
nouripourf@sums.ac.ir

3

Recruitment center
Name of recruitment center
AliAsghar Diabetes Clinic
Full name of responsible person
Fatemeh Nouripour
Street address
Meshkinfam street
City
Shiraz
Province
Fars
Postal code
0000000000
Phone
+98 71 3228 8602
Email
nouripourf@sums.ac.ir

4

Recruitment center
Name of recruitment center
Shahid Motahhari Clinic
Full name of responsible person
Dr. Ali Zamani
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7166776770
Phone
+98 71 3612 1000
Email
nouripourf@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Younes Ghasemi
Street address
Central building of Shiraz University of Medical Sciences, Zand st
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Nouripour
Position
کارشناس ارشد تغذیه
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of nutrition and food sciences, Razi Blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1007
Email
nouripourf@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Mazloom
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
بولوار رازی، دانشکده تغذیه و علوم غذایی
City
shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1007
Email
zohreh.mazloom@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Nouripour
Position
Master of science in nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of nutrition and food sciences, Razi Blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1007
Email
nouripourf@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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