Effect of soy flour enriched bread consumption or regular weight loss diet on anthropometric indices, blood pressure and serum lipid profile and its association with apoE genotype in over weight/ obese women: a randomized controlled trial.
Design: cross-over clinical trial. Participants: 30 girl students with overweight and obesity. Objective: Evaluation the effects of soy bread consumption on cardiovascular disease risk factor and anthropometric indices and its association with apoE genotype. Inclusion criteria: overweight or obese females. Exclusion criteria: use of specific drugs or supplements, allergy to soya. Setting and conduct: After a 2 week run-in period, all the participants will receive a weight loss diet then participants will be randomly assigned to soy bread and regular diet each for 6 weeks. After 3 weeks washout period, the second phase will be started. Then the participants will be crossed over to the alternate group for additional 6 weeks. To assess the compliance of the participants, every two week a 3 day dietary record and a 3 day physical activity record will be taken. Anthropometric measurements and biochemical assessments including serum triglyceride, total-cholesterol, low density lipoprotein (LDL-C) and high density lipoprotein cholesterol (HDL-c ) levels will be measured at the beginning and end of each phases. apoE genotype will be determined at the beginning of the study. Interventions: First the individual energy requirements will be calculated. Then of calculated calorie 300-500 calorie will be reduced for weight loss. The target macro nutrient composition for all participants will be 50-60% of energy as carbohydrate, 15-20% of energy as protein and less than 30% of energy as fat.
Women in the soy bread group were asked to replace 120 gr of soy bread with the equal amount of their usual bread intake.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013073114237N1
Registration date:2013-09-05, 1392/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-05, 1392/06/14
Registrant information
Name
Elham Sharifi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1730 6006
Email address
elham_sharifi@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-09-28, 1391/07/07
Expected recruitment end date
2012-11-04, 1391/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of soy flour enriched bread consumption or regular weight loss diet on anthropometric indices, blood pressure and serum lipid profile and its association with apoE genotype in over weight/ obese women: a randomized controlled trial.
Public title
Effect of soy flour enriched bread on cardiovascular diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were; female at age range of 19-35 years old; body mass index (BMI) between 25 and 35; no history of any chronic or acute diseases including; diabetes, CVD, hepatic diseases, renal diseases, cancer; not adherence to a specific diet or other medically prescribed diet no lactation and no pregnancy; no consumption of drugs and dietary supplements. Exclusion criteria: not adherence to the study protocol; use of specific drugs or supplementation; smoking; incidence of chronic diseases such as cardiovascular diseases and allergy to soya.
Age
From 19 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
8174673461
Approval date
2012-11-14, 1391/08/24
Ethics committee reference number
391432
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
High Density Lipoprotein
Timepoint
Week2, Week8, Week11, Week17
Method of measurement
mg/dl, Direct enzymatic method
2
Description
Low Density Lipoprotein
Timepoint
Week2, Week8, Week11, Week17
Method of measurement
mg/dl, Friedewald equation
3
Description
Serum total choolestrol levels
Timepoint
Week2, Week8, Week11, Week17
Method of measurement
mg/dl, Enzymatic method
4
Description
Serum triglyceride levels
Timepoint
Week2, Week8, Week11, Week17
Method of measurement
mg/dl, Enzymatic method
5
Description
ApoE genotype
Timepoint
Week2
Method of measurement
PCR method
Secondary outcomes
1
Description
Weight
Timepoint
baseline, Week2, Week8, Week11, Week17
Method of measurement
Kilogram, Scale
2
Description
Body Mass Index
Timepoint
Baseline, Week2, Week8, Week11, Week17
Method of measurement
kg/m2, Weight/Height square
3
Description
Waist circumference
Timepoint
Week 2, Week 8, Week 11,Week17
Method of measurement
meter, centimeter
4
Description
Hip circumference
Timepoint
Week 2, Week 8, Week 11, Week 17
Method of measurement
meter, centimeter
5
Description
Body composition
Timepoint
Week2, Week8, Week11, Week17
Method of measurement
Body Analyser systeme
6
Description
Systolic blood pressure
Timepoint
Week 2, Week 8, Week 11, Week 17
Method of measurement
Sphygmomanometer
7
Description
Diastolic blood pressure
Timepoint
Week 2, Week 8, Week 11, Week 17
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
Soy bread group: energy requirement will be calculated according to equations suggested by the Institute of Medicine, Food and Nutrition Board. for weight loss 300-500 calorie of calculated energy will be reduced . person in this intervention were asked to replace 120gr of soy bread with usual bread intake or other cereal. macronutrient composition for all participants will be 50-60% as carbohydrate, 15-20% as protein and <30% as fat.
Category
Treatment - Other
2
Description
Usual diet: energy requirement for each participant will calculated based on equations suggested by the Institute of Medicine, Food and Nutrition Board. 300-500 calorie will reduced for weight loss. subject in this diet will asked to continue their usual bread intake and other cereal products and not to consume soy product. macronutrient composition in this group is similar to the soy bread group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Hassan Entezari
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Payman Adibi
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan 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, School of Nutrition and Food Science, Isfahan University of Medica
Full name of responsible person
Elham Sharifi Zahabi
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2752
Fax
Email
Elham_sharifi@nutr.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medica
Full name of responsible person
Elham Sharifi Zahabi
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2752
Fax
Email
Elham_sharifi@nutr.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medica
Full name of responsible person
Elham Sharifi Zahabi
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2752
Fax
Email
Elham_sharifi@nutr.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)