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The effects of functional cake in patients with metabolic syndrome

Protocol summary

Study aim
Evaluating the effect of cake preparation with oak flour with cake made with wheat flour following a balanced hypocaloric diet on nutritional status and metabolic profile in obese and overweight patients with metabolic syndrome
Design
90 patients are randomly divided into two groups as follows: Group A: The intervention group received 30 gr of oak cake twice a day + a balanced hypocaloric diet Group B: The control group received 30 gr of wheat cake twice a day + a balanced hypocaloric diet This process is followed for 10 weeks.
Settings and conduct
This was a randomized, double-blinded, 10-week study. Participants were randomly allocated to two groups receiving either oak cake (2×30 g)/day o or wheat (2×30 g)/day. All participants were put on a caloric-restricted diet throughout the 10-week study. Body composition and biochemical indices were assessed before and after the intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria were both sexes between 20-60 years of age, body mass index (BMI) of 25–35 kg/m2, having metabolic syndrome
Intervention groups
1: received 30 gr of oak cake twice a day + a balanced hypocaloric diet 2: received 30 gr of oak cake twice a day + a balanced hypocaloric diet
Main outcome variables
HOMA-IR

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170506033836N2
Registration date: 2020-10-15, 1399/07/24
Registration timing: retrospective

Last update: 2020-10-15, 1399/07/24
Update count: 0
Registration date
2020-10-15, 1399/07/24
Registrant information
Name
Mohsen Mohammadi Sartang
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
mohamadism@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of functional cake in patients with metabolic syndrome
Public title
The effects of functional cake
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20 to 60 years Body mass index (BMI) of 25–35 kg/m2 According to the ATP III definition, metabolic syndrome is present if three or more of the following five criteria are met: waist circumference over 102 cm (men) or 88 cm (women), blood pressure over 130/85 mmHg, fasting triglyceride (TG) level over 150 mg/dl, fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl Stable body weight (weight change less than 3 kg in the last 3 months) Not participating in weight loss programs for the past 6 months
Exclusion criteria:
Diabetic patients receiving blood sugar-lowering drugs and insulin History of alcohol consumption Smoking Pregnant and lactating women People with mental illness, cancer, thyroid, cardiovascular, pulmonary, renal, hepatic, eating disorders Taking drugs that affect appetite, body weight and lipid metabolism or have anti-inflammatory effect
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization between the two groups will be done by block randomization. In this way, the size of the blocks is considered 4 and all possible scenarios are written for two groups A and B and this process is repeated until the number reaches 80 people. Then a number is given to each of the block components using a random number table. The numbers given to each of the block components represent the number assigned to each person in advance. This identifies the group assigned to each individual.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, Investigators, and associated research and laboratory personnel will remain blinded to patient allocation until after study completion.The designed placebo is completely similar to the intervention group in terms of color, size and model. For blinding the packs of cakes is coded in A and B sounds by the third party who is not involved in the research process.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Baqiyatallah University of Medical Sciences, Tehran, Iran
Street address
Tehran, Vanak Square, Mulla Sadra Street
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.BMSU.BAQ.REC.1399.002

Health conditions studied

1

Description of health condition studied
Metabolic Syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome

2

Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Anthropometric measures
Timepoint
Before and after the intervention
Method of measurement
Bioelectric impedance analysis

2

Description
blood pressure
Timepoint
Before and after the intervention
Method of measurement
digital sphygmomanometer

3

Description
Fasting blood sugar
Timepoint
Before and after the intervention
Method of measurement
Commercial kits

4

Description
Insulin
Timepoint
Before and after the intervention
Method of measurement
ELISA kit

5

Description
Insulin resistance index (HOMA-IR)
Timepoint
Before and after the intervention
Method of measurement
Formula

6

Description
Lipids profile
Timepoint
Before and after the intervention
Method of measurement
Commercial kits

7

Description
Malon de aldehyde (MDA)
Timepoint
Before and after the intervention
Method of measurement
Tubarbitoric acid method (TBARS)

8

Description
C-reactive protein
Timepoint
Before and after the intervention
Method of measurement
ELISA kit

9

Description
Adiponectin
Timepoint
Before and after the intervention
Method of measurement
ELISA kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Functional cake group containing oak powder.The caloric content of both oak and wheat cakes will be equal, so due to the higher calorie content of oak flour, 10 grams of oak flour is sweetened in the preparation of cakes containing oak flour and about 13.8 grams of wheat flour will be used in the preparation of cakes containing wheat flour.In this way, a cake with a weight of approximately 30 grams will be produced and standardized packaging
Category
Treatment - Other

2

Description
Control group: Ordinary cake group containing wheat powder
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
hospitals and clinics
Full name of responsible person
Mohsen Mohamadi
Street address
Khalili street
City
Shiraz
Province
Fars
Postal code
11111111
Phone
+98 71 3612 2206
Email
mohsen.nut85@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Siavoosh Babajafari
Street address
Khalili street
City
Shiraz
Province
Fars
Postal code
11111111
Phone
+98 71 3612 2206
Email
mohsen.nut85@yahoo.com
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
Mohsen Mohamadi
Position
Phd
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Khalili street
City
Shiraz
Province
Fars
Postal code
11111111
Phone
+98 71 3612 2206
Email
mohsen.nut@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohsen Mohamadi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Khalili street
City
Shiraz
Province
Fars
Postal code
1111111
Phone
+98 71 3612 2206
Email
mohamadism@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohsen Mohamadi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Khalili street
City
Shiraz
Province
Fars
Postal code
1111111
Phone
+98 71 3612 2206
Email
mohamadism@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Laboratory data file can be published
When the data will become available and for how long
After the intervention
To whom data/document is available
For researchers and industry professionals
Under which criteria data/document could be used
The use of data is allowed in the industry
From where data/document is obtainable
Mohsen Mohammadi Sartang mohamadism@sums.ac.ir
What processes are involved for a request to access data/document
The possibility of requesting is checked via email and will be answered within a week
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