Effect of legume consumption on serum adiponectin level, inflammatory biomarkers and cardiovascular risk factors in healthy first degree relatives of diabetic patients
The objective of this study is to investigate the effect of legume consumption on serum adiponectin level, inflammatory biomarkers and cardiovascular risk factors in healthy first degree relatives of diabetic patients. Adults aged more than 30 years who are the healthy first degree relatives of diabetic patients are included. The subjects not following the legume consumption will be excluded. The requirement sample size is 19 subjects. This cross-over study will be conducted in 14 weeks that including two 6-weeks and one 2-weeks wash-out period. At the beginning of study, one group randomly assigned to legume packages and one group assigned to healthy recommendations and at the next course, the two groups will be crossed over. At the beginning and end of each period, anthropometric indices, blood pressure, inflammatory markers, adiponectin, lipid profiles, fasting blood glucose and hemoglobin A1C will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306212839N5
Registration date:2013-07-01, 1392/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-01, 1392/04/10
Registrant information
Name
Leila Azadbakht
Name of organization / entity
Nutrition department, School of health, Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2719
Email address
azadbakht@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of legume consumption on serum adiponectin level, inflammatory biomarkers and cardiovascular risk factors in healthy first degree relatives of diabetic patients
Public title
Effect of legume consumption on cardiovascular risk factors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 30 years, lack of pregnancy and lactation, no history of liver and kidney diseases, cancers, allergies, hypo- and hyperthyroidism, gastrointestinal problems (bloating and irritable bowel syndrome) and psychosomatic problems. Not using of anti-inflammatory drugs (corticosteroids) and blood glucose lowering drugs (Metformin and Insulin). Not changes in body weight more than 3 kilograms during last two months. Not cigarette smoking. Not following a particular diet.
Exclusion criteria:
Not using recommended amounts of legumes, not following the research protocol, beginning to consume particular medications during the study, beginning to cigarette smoking during the study, being pregnant during the study, incidence of liver and kidney diseases, kidney stones, cancers, allergies, hypo- and hyperthyroidism, gastrointestinal problems (bloating and irritable bowel syndrome), trauma, surgery and psychosomatic problems during the study. To start Insulin use or blood glucose lowering drugs (Metformin) during the study, change in type and dosage of medications during the study.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
19
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Commitee of Isfahan university of medical sciences
Street address
Azadi square, Hezar jarib street, Isfahan university of medical sciences