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The effects of dietary modification programme (low-fat, low-carb and high-protein diet) on mood status, fatigue and quality of life in patients with ulcerative colitis

Protocol summary

Study aim
The aim of the current study was to evaluate the effects of dietary modification programme (low-fat, low-carb and high-protein diet) on fatigue, mood status, quality of life and lipid profile of ulcerative colitis patients during remission phase.
Design
This was a parallel group, randomized controlled trial Which has been performed on 80 patients with ulcerative colitis. Blocked randomization has been used for randomization.
Settings and conduct
We consecutively evaluated patients with suspect of ulcerative colitis in the inflammatory bowel disease center, Salamat clinic, Isfahan University of Medical Sciences, Isfahan, Iran. Subjects were admitted directly in our inflammatory bowel disease clinic or referred from other general medicine or gastroenterology clinics located in Isfahan city. Patients who were assigned to the intervention group participated in a 3-months dietitian-led dietary modification programme (low-fat, low-carb and high-protein diet). Patients randomized to the control group received routine care at the inflammatory bowel disease center.
Participants/Inclusion and exclusion criteria
Patients aged 18–80 years with a confirmed diagnosis of ulcerative colitis by gastroenterologist were eligible for inclusion. Subjects with dose changes of azathioprine, mercaptopurine, methotrexate, or biologics in the preceding 12 weeks; oral antibiotics, probiotics, prebiotics or especial diet in the preceding 8 weeks were excluded.
Intervention groups
Patients who were assigned to the intervention group participated in a 3-months dietitian-led dietary modification programme (low-fat, low-carb and high-protein diet). Patients randomized to the control group received routine care at the inflammatory bowel disease center.
Main outcome variables
Mood status, fatigue and quality of life are the main outcomes of this study

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150304021342N2
Registration date: 2020-05-23, 1399/03/03
Registration timing: retrospective

Last update: 2020-05-23, 1399/03/03
Update count: 0
Registration date
2020-05-23, 1399/03/03
Registrant information
Name
Babak Tamizifar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 5555
Email address
tamizib@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
2019-11-22, 1398/09/01
Actual recruitment end date
2020-04-19, 1399/01/31
Trial completion date
2020-04-24, 1399/02/05
Scientific title
The effects of dietary modification programme (low-fat, low-carb and high-protein diet) on mood status, fatigue and quality of life in patients with ulcerative colitis
Public title
Effect of low-fat, low-carb and high-protein diet in ulcerative colitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18–80 years Confirmed diagnosis of ulcerative colitis by gastroenterologist
Exclusion criteria:
Subjects with dose changes of azathioprine, mercaptopurine, methotrexate, or biologics in the preceding 12 weeks Consumption of probiotics, prebiotics or following especial diet in the preceding 8 weeks
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
A blocked randomization method with randomly permuted blocks sizes 4 was used to assign each patients to an intervention or control group, to guarantee recruitment balance between the 2 groups and avoid possible risk for selection bias. Depending on age and gender, individuals are placed in blocks of four and are placed in one of the intervention and control groups using a table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.065

Health conditions studied

1

Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
Mood status
Timepoint
At baseline and after 12 weeks
Method of measurement
Depression, Anxiety, Stress-21 questionnaire

2

Description
Fatigue
Timepoint
At baseline and after 12 weeks
Method of measurement
Fatigue Severity Scale

3

Description
Quality of life
Timepoint
At baseline and after 12 weeks
Method of measurement
36-Item Short Form Survey

Secondary outcomes

1

Description
Lipid profile
Timepoint
At baseline and after 12 weeks
Method of measurement
Colorimetric method

Intervention groups

1

Description
Intervention group: Patients who were assigned to the intervention group participated in a 3-months dietitian-led dietary modification programme (low-fat, low-carb and high-protein diet). Participants were provided dietary guidelines in the form of an educational booklet and dedicated diet. The dietary guidelines of dietary modification programme primarily focused on the reduction of ulcerative colitis symptoms and nutritional deficiency risks. The provided guidelines endeavored to consolidate the existing documents as well as existing guidelines on diet and ulcerative colitis. The dietary modification programme consisted of recommendation that participants eat often and little (4-6 times per day), consume foods at a balanced temperature, decrease consumption of spicy foods, decrease excess intake of fat, decrease simple carbohydrate and drink adequate fluids. Moreover, increase good quality protein and eliminate dairy products in the presence of lactose intolerance. Furthermore, it included avoidance of margarine, limiting alcohol, caffeine and commercially prepared foods including fast foods, ready meals and canned foods.
Category
Treatment - Other

2

Description
Control group: Patients randomized to the control group received routine care at the inflammatory bowel disease center. Usual dietary advice included general oral and written information about healthy food choices based on the Healthy Eating Plate with 50–60% carbohydrates, 15–20% protein and 30% total fat. This composition was more parallel to the Iranian dietary pattern.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Salamat Clinic
Full name of responsible person
Babak Tamizifar
Street address
Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
btamizi@med.mui.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou
Street address
Hezarjarib Ave., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Babak Tamizifar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroentrologist
Street address
Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
btamizi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Tamizifar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroentrologist
Street address
Depart. of G.I, Alzahra University hopspital, Sofe BLVD
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Fax
+98 31 3668 4510
Email
tamizib@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Tamizifar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroentrologist
Street address
Depart. of G.I, Alzahra University hopspital, Sofe BLVD
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Fax
+98 31 3668 4510
Email
tamizib@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Major part of information will be available for population
When the data will become available and for how long
12 months after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
To conduct similar studies
From where data/document is obtainable
Babak Tamizifar
What processes are involved for a request to access data/document
The data will send as soon as possible, after receiving the request
Comments
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