Protocol summary
-
Study aim
-
Determining The effects of legume-based DASH diet on anthropometric factors, glucose & lipid profiles and testosterone level in women with polycystic ovary syndrome (PCOS)
-
Design
-
Randomized clinical trial
-
Settings and conduct
-
The present study is a randomized controlled clinical trial to evaluate the effect of legume-based DASH counseling and diet on anthropometric factors, glucose & lipid profiles and testosterone level factors in patients with polycystic ovary syndrome, which is referred to Shahid Sadoughi hospital will be performed in Yazd for 12 weeks. In addition, people with PCOS receive their routine treatment under the supervision of a specialist. Age and BMI is a confounding factor and is eliminated in statistical models. Participation in the study is completely free and is managed by explaining in detail the study process, goals, benefits and limitations and obtaining written and oral consent with the patient's signature.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:
1. Women of reproductive age and before menopause (20-50 years)
2. Women with PCOS according to the Rotterdam criteria
3. Oligomenorrhea or amenorrhea
4. Clinical or laboratory hyperandrogenism
Exclusion criteria:
1. Age less than 20 or more than 50 years
2. Pregnancy, miscarriage or breastfeeding in the last 6 months
3. Oligomenorrhea caused by secondary causes, including endocrine disorders (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, adrenal disorders)
4. Previous history or current getting with any cancer
5. History of type 2 diabetes
6. Intrauterine Insemination (IUI) or In Vitro Fertilization( IVF)
7. Special diets or low-calorie diets in the past three months, including vegetarian diets
-
Intervention groups
-
legume-based DASH diet recipient group
-
Main outcome variables
-
Anthropometric factors, glucose & lipid profiles and testosterone
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20120913010826N33
Registration date:
2023-06-12, 1402/03/22
Registration timing:
prospective
Last update:
2024-08-22, 1403/06/01
Update count:
1
-
Registration date
-
2023-06-12, 1402/03/22
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2023-06-20, 1402/03/30
-
Expected recruitment end date
-
2023-07-21, 1402/04/30
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effects of legume-based DASH diet on anthropometric factors, glucose & lipid profiles and testosterone level in women with polycystic ovary syndrome (PCOS): A randomized clinical trial
-
Public title
-
Effect of legume-based DASH diet in patients with polycystic ovary syndrome
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Women of reproductive age and before menopause (20-50 years)
Women with PCOS according to the Rotterdam criteria
Oligomenorrhea or amenorrhea
Clinical or laboratory hyperandrogenism
Exclusion criteria:
Pregnancy, miscarriage or breastfeeding in the last 6 months
Oligomenorrhea caused by secondary causes, including endocrine disorders (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, adrenal disorders)
Previous history or current getting with any cancer
History of type 2 diabetes
Intrauterine Insemination (IUI) or In Vitro Fertilization) IVF(
Special diets or low-calorie diets in the past three months, including vegetarian diets
-
Age
-
From 20 years old to 50 years old
-
Gender
-
Female
-
Phase
-
3
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
54
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The stratified randomization method is used for random allocation. Therefore, we first classify BMI into three groups: standard, overweight, and obese, and then use a simple random assignment method in each group.
First, eligible people are classified into BMI groups, and then in each BMI group, the first eligible person is number 1 and the next person is number 2, and so on until the 27th person. Random Allocation software version 1 is used to prepare the random allocation list.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
The term "legumes" includes legumes, soybeans, peas, beans, etc.
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2023-05-28, 1402/03/07
-
Ethics committee reference number
-
IR.SSU.SPH.REC.1402.018
Health conditions studied
1
-
Description of health condition studied
-
polycystic ovary syndrome
-
ICD-10 code
-
E28.2
-
ICD-10 code description
-
Polycystic ovarian syndrome
Primary outcomes
1
-
Description
-
HOMA-IR index
-
Timepoint
-
Before intervention and 16 weeks after intervention
-
Method of measurement
-
HOMA-IR = (Glu ×Insulin)/405
2
-
Description
-
Low density lipoprotein cholesterol (LDL)
-
Timepoint
-
Before intervention and 16 weeks after intervention
-
Method of measurement
-
Special kit
3
-
Description
-
High density lipoprotein cholesterol (HDL)
-
Timepoint
-
Before intervention and 16 weeks after intervention
-
Method of measurement
-
Special kit
4
-
Description
-
Triglyceride
-
Timepoint
-
Before intervention and 16 weeks after intervention
-
Method of measurement
-
Special kit
5
-
Description
-
Total cholesterol
-
Timepoint
-
Before intervention and 16 weeks after intervention
-
Method of measurement
-
Special kit
6
-
Description
-
FBS
-
Timepoint
-
Before intervention and 16 weeks after intervention
-
Method of measurement
-
Special kit
7
-
Description
-
Serum insulin
-
Timepoint
-
Before intervention and 16 weeks after intervention
-
Method of measurement
-
Special kit
8
-
Description
-
Free testosterone
-
Timepoint
-
Before intervention and 16 weeks after intervention
-
Method of measurement
-
Special kit
Secondary outcomes
1
-
Description
-
Weight, fat mass, fat free mass, RMR, body mass index and visceral fat
-
Timepoint
-
Before intervention and 16 weeks after the intervention
-
Method of measurement
-
Omron digital Scale
2
-
Description
-
Waist,Hip circumference
-
Timepoint
-
Before intervention and 16 weeks after the intervention
-
Method of measurement
-
Meter
3
-
Description
-
Total energy intake, total nutrients intake
-
Timepoint
-
Before intervention and 16 weeks after the intervention
-
Method of measurement
-
24 hour recall
4
-
Description
-
The length of the menstrual cycle
-
Timepoint
-
Before intervention and 16 weeks after the intervention
-
Method of measurement
-
questionnaire
Intervention groups
1
-
Description
-
Intervention group: Legume-based DASH diet. DASH diet (Dietary Approaches to Stop High Blood Pressure) that contains 50-55% carbohydrates, 15-20% protein and 25-30% fat. The DASH diet is high in fruits, vegetables, whole grains, and low-fat dairy, and low in saturated fat, cholesterol, and refined grains. In the legume-based DASH diet, we replace up to 1 to 3 units of meat and grains with more legumes and soybeans. The calories needed by each patient are estimated based on the basal metabolic rate (using the Harris-Benedict equation) and the levels of physical activity and energy resulting from food metabolism. For people who are overweight or obese, a caloric restriction of 500 to 700 kcal less than the calculated energy requirement for each person is considered. 500 kcal for those whose BMI is in the range of 25-31 kg/m2 and 700 kcal for those with a BMI greater than 31 kg/m2 will be deducted from the total energy needed by each person, and weight loss is intended for these people. The replacement list is provided to the patient while educating the patient to make it easier to choose foods and comply with the principle of diversity between the components of each food group.
-
Category
-
Lifestyle
2
-
Description
-
Control group: A standard diet that contains 50-55% carbohydrates, 15-20% protein and 25-30% fat. The calories needed by each patient are estimated based on the basal metabolic rate (using the Harris-Benedict equation) and the levels of physical activity and energy resulting from food metabolism. For people who are overweight or obese, a caloric restriction of 500 to 700 kcal less than the energy requirement calculated for each person is considered. 500 kcal for people whose BMI is in the range of 25-31 kg/m2 and for people whose BMI is more than 31 kg/m2, 700 kcal is deducted from the total energy requirement of each person, and weight loss for These people are considered. The replacement list is provided to the patient while educating the patient to make it easier to choose foods and comply with the principle of variety between the components of each food group.
-
Category
-
Lifestyle
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Research Assistant, Yazd 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available