Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT04136093
Eligibility Criteria:
Inclusion Criteria:
* postmenopausal women, with the absence of menses of over 12 months or serum follicle stimulating hormone \> 30 IU/mL;
* with central obesity waist circumference (WC) ≥ 80 cm
* with low physical activity (PAL = 1,40);
* who wished to lose weight and weight loss maintenance;
* and have at least one other criterion of metabolic syndrome increased systolic blood pressure ≥ 130 mm Hg or high blood pressure diastolic ≥ 85 mm Hg or ongoing treatment of previously diagnosed hypertension, increased serum triglyceride levels above \>150 mg/dl (1.7 mmol/l) or ongoing therapy hypertriglyceridemia, decreased HDL cholesterol below than \<50 mg/dl (1.3 mmol/l), and fasting blood glucose \> 100 mg/dl (5.6 mmol / l) or ongoing treatment of previously diagnosed type 2 diabetes.
Exclusion Criteria:
* thyroid disease (hypothyroidism, hyperthyroidism, thyroiditis);
* hypercortisolism, Cushing's syndrome;
* kidney diseases;
* type 1 diabetes;
* asthma treated with oral and injectable steroids;
* cancers; mental disorders;
* New York Heart Association (NYHA) Class III heart failure;
* as well as any drug is known to influence liver function;
* endocrine disorders;
* hormonal replacement therapy;
* significant weight change in the six months prior to the current study;
* impaired absorption of nutrients (celiac disease, inflammatory bowel disease);
* intolerance or food allergy to key components of the intervention diets;
* smoking
* excessive alcohol consumption (consumption of more than 2 alcohol units per day - one alcohol unit equals one bottle of beer (340 g) or one glass of wine (140 g) or one glass of spirits (42.5 g of 40% spirit).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
65 Years
Study:
NCT04136093
Study Brief:
Protocol Section:
NCT04136093