Protocol summary

Summary
The purpose of this randomized controlled trial is to investigate the effect of lentil sprouts consumption on inflammation and oxidative stress of patients with Type 2 Diabetes mellitus. According to statistical calculations 40 patients (male and female) with Type2 Diabetes attending Diabetes, Association, Iran, Branch center will be recruited. These patients will be randomly divided into 2 groups (intervention and control). Patients not taking Insulin will be enrolled in this study. Pregnant or breast feeding women won’t be participated in this study. Patients in the intervention group (20) will consume 60-grams lentil sprouts daily and those in the control group (20) will receive 1 cup of boiled water daily for 8 weeks, they will continue their habitual diet, without getting lentil sprouts. All patients were asked to maintain their usual diet and physical activity level, and not to alter their life style during the intervention. Patients will be matched in two groups according to their age, sex, medications and biomass index. At the beginning and end point of the study, medical history, 3 day food records and physical activity questionnaires will be collected and anthropometric measurements (length and, weight) will be recorded. At the beginning and end point of the study, after 14 hour overnight fasting blood samples will be taken for biochemical analysis, including inflammatory factors (High-sensitivity C - reactive protein, Tumor necrosis factor alph and adiponektin) and antioxidant indicators (total antioxidant capacity, total oxidant statue).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201310274105N15
Registration date: 2014-02-08, 1392/11/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-08, 1392/11/19
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical science
Expected recruitment start date
2013-10-25, 1392/08/03
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Lentil sprouts consumption on oxidative stress and inflammatory factors of overweight and obesity patients with Typ2 diabetes mellitus.
Public title
Effect of lentil sprouts on diabetic people.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: - type II diabetes; lack of Insulin; being in the age range 65-30 years old and BMI=40-25. Exclusion criteria: pregnancy and breast-feeding women; liver disease, renal, hypothyroidism and hyperthyroidism disease; alcohol consumption, smoking, contraceptive pills; taking glucocorticoid drugs; consumption of lentil sprouts, supplements or multivitamins containing antioxidants during the 3 months prior to 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: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee, Research Institute For Endocrine Sciences, Shahid Beheshti University of Medical S
Street address
#24, Parvaneh st, Yemen st, Chamran Exp
City
tehran
Postal code
0098
Approval date
2013-10-22, 1392/07/30
Ethics committee reference number
22ECRIES92.7.30

Health conditions studied

1

Description of health condition studied
Diabetes Type2
ICD-10 code
E10-14
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Total Antioxidant capacity(TAC)
Timepoint
before and after 8 weeks of intervention
Method of measurement
kit, TAC

2

Description
Total oxidant status
Timepoint
before and after 8 weeks of intervention
Method of measurement
kit, TOC

3

Description
Adiponecktin
Timepoint
before and after 8 weeks of intervention
Method of measurement
adiponecktin kit

4

Description
High-sensitivity C-reactive Protein
Timepoint
before and after 8 weeks of intervention
Method of measurement
hs-CRP Kit

5

Description
Tumor necrosis factor alph
Timepoint
before and after 8 weeks of intervention
Method of measurement
TNFα kit

Secondary outcomes

empty

Intervention groups

1

Description
Patients in intervention group received 60 grams of lentil sprouts per day. People will take lentil sprouts into salad with lunch and dinner. Duration of intervention will be 8 weeks. Sprouts recipe lentils (brown lentils, dry): 1. lentils place into water within 24 hours; 2. at this stage, lentils are placed into a lattice; 3. after 30 hours, lentil sprouts are prepared. We keep this stuff into refrigerator.
Category
Other

2

Description
Patients in control group will drunk one cup of boiling water a day for 8 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Association, Iran
Full name of responsible person
Zahra aslani
Street address
#27, Ramin Malekooti st , patris lomomba st, sattarkhan EXP , Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fereidon azizi
Street address
Research Institute for Endocrine Sciences, #24 Parvaneh st, Yemen st, Chamran Exp, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Full name of responsible person
Parvin Mirmiran
Position
p.h.D
Other areas of specialty/work
Street address
Research Institute For Endocrine Sciences, #24 Parvaneh st, Yemen st, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2503
Fax
Email
mirmiran@endocrine.ac.ir , parvin.mirmiran@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
zahra aslani
Position
MSc student in Health Sciences in Nutrition
Other areas of specialty/work
Street address
Research Institute For Endocrine Sciences, #24 Parvaneh st, Yemen st, Chamran Exp Tehran
City
Tehran
Postal code
0098
Phone
+98 21 2243 2500
Fax
Email
aslani_zahra@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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