Status:
UNKNOWN
Diet for the Maintenance of Weight Loss and Metabolic Health in Obese Postmenopausal Women
Lead Sponsor:
Poznan University of Life Sciences
Conditions:
Metabolic Syndrome
Diet Modification
Eligibility:
FEMALE
50-65 years
Phase:
NA
Brief Summary
The aim of the study will be comparing the effectiveness of two diets: moderate in fat with a high proportion of monounsaturated fatty acids (MUFAs) - the Mediterranean diet (MED) and 2) the low in fa...
Detailed Description
The treatment of obesity can present a challenge because of the difficulty in maintaining body weight loss beyond one year. The aim of the study will be comparing the effectiveness of two energy-unres...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04136093
Start Date
February 29 2020
End Date
September 1 2022
Last Update
April 9 2020
Active Locations (1)
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1
Poznan University of Life Science
Poznan, Poland, 60-624