The aim of this study was to determine the effect of legume intake on lipid profiles, stress oxidative and inflammatory markers in insulin resistance subjects. 30 insulin resistance subjects participate. Insulin resistance defined as Homeostasis model assessment of insulin resistance (HOMA-IR)> 4.65. Inclusion criteria are body mass index 25-30 Kg/m2 and intake of 2 or lower serving/wk of legumes and exclusion criteria is intake of antioxidant and multivitamin supplement. After 3 weeks of run-in period on a usual diet, we randomly assigned subjects to three interventional groups: control diet including Therapeutic Lifestyle Change or TLC (A diet), TLC diets with 1 ser/d of legumes intake that legume replace with meat intake (B diet), or TLC diet with 3 ser/d of legumes intake that replace with meat intake (C diet), each one for 8 weeks. Each subject followed the three diets and had two washout periods, each washout for 4 weeks. 6 different models were in this study including ABC, ACB, BCA, CBA, BAC, and CAB. Blood samples were drawn at baseline and end of interventions and washout period and biochemical index measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202251640N7
Registration date:2012-03-19, 1390/12/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-19, 1390/12/29
Registrant information
Name
Parvin Mirmiran
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
mirmiran@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of legumes intake on the lipid profile, stress oxidative and inflammatory markers in insulin resistance
Public title
Evaluation of legumes intake effects on the lipid profile, stress oxidative and inflammatory markers in insulin resistance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: subjects aged 16-80 years; no changes in weight over the past 3 months; consumption of 2 or less serving of legumes per week; no specific diet; body mass index 25-30 kg/m2. Exclusion criteria: hepatic, renal and gastrointestinal diseases, allergy, diabetes mellitus, hyperlipidemia; take of antioxidants and multivitamins-minerals supplementation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Street address
No 24, Parvaneh st., Yemen Blvd., Chamran exp.
City
Tehran
Postal code
Approval date
2012-02-22, 1390/12/03
Ethics committee reference number
393
Health conditions studied
1
Description of health condition studied
Insulin resistance
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test
2
Description of health condition studied
Insulin resistance
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Glucose
Timepoint
Baseline, 8 and 12 weeks after intervention
Method of measurement
Biochemical analysis
2
Description
Insulin
Timepoint
Baseline, 8 and 12 weeks after intervention
Method of measurement
Biochemistery analysis
3
Description
Lipid profile
Timepoint
Baseline, 8 and 12 weeks after intervention
Method of measurement
Biochemical analysis
4
Description
Oxidative stress
Timepoint
Baseline, 8 and 12 weeks after intervention
Method of measurement
Biochemical analysis
5
Description
Inflammatory markers
Timepoint
Baseline, 8 and 12 weeks after intervention
Method of measurement
Biochemical analysis
Secondary outcomes
empty
Intervention groups
1
Description
Legumes- control diet including 15% protein, 30% fat and 55% carbohydrate with 1 serving legumes for 8 weeks
Category
Treatment - Other
2
Description
control diet including 15% protein, 30% fat and 55% carbohydrate for 8 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes clinice of Talaghani Hospital
Full name of responsible person
Street address
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
Parvin Mirmiran
Street address
No.24, Parveneh St., Yemen Blvd., Chamran Exp.
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
Name of organization / entity
Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, N