Overweight and obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
Subjects are randomized to six groups:
Group 1: Menopausal women who receive 4 capsules/day of placebo
Group 2: Menopausal women who receive 4 capsules/day of 150 mg ea
Sponsors
Biocentury SLU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females (50% menopausal and 50% fertile) 2. Aged between 20 and 55 years old 3. No documented cardiovascular disease (ischemic heart disease ? angina or recent or old myocardial infarction or previous or cerebral vascular accident, peripheral vascular disease) 4. Body mass index between 27.5 and 34.9 Kg/m2
Exclusion criteria
Exclusion criteria: 1. Previous history of cardiovascular disease (ischemic heart disease ? angina or recent or old myocardial infarction, cerebral vascular accident, or peripheral vascular disease) 2. Any severe chronic disease, alcoholism or other toxic abuse 3. Subjects who had taken drugs or followed dietary interventions with potential effects on body weight in the last 3 months 4. Subjects who had changed their weight +/-3 kg in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in body weight measured using a weigh scale, Roman type, Brand Atlantis with an accuracy of 100 grams, at baseline, 1, 2, 3, 4, 5 and 6 months after intervention 2. Changes in body mass index measured applying the Quetelet index (weight/(height)^2), at baseline, 1, 2, 3, 4, 5 and 6 months after intervention 3. Changes in waist perimeter measured using a SECA201 (CBA04) measuring tape, at baseline, 1, 2, 3, 4, 5 and 6 months after intervention 4. Changes in fat body mass and distribution of fat in the body measured by DEXA (Dual-energy X-ray Absorptiometry), at baseline, 3 and 6 months after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Medical record: A complete medical record will be obtained from all participants, which included data on alcohol intake, smoking and dietary habits, at abseline, 3 and 6 months 2. Blood pressure and heart rate will be measured with an electronic apparatus Omron HEM-705CP (Netherlands), at baseline, 3 and 6 months after intervention 3. Nutrition assessment, and general analyses: 3.1. Data collected as part of a 7 day dietary register, including total quantity of calories and proportion corresponding to carbohydrates, lipids and proteins, assessed by Food Processor Nutrition & Fitness software during the week previous to the physical and laboratory assessment, at at baseline, 1, 2, 3, 4, 5 and 6 months after intervention 3.2. Protein nutrition, determined on the basis of the following parameters: hemoglobin, total lymphocyte count, total proteins, albumin, prealbumin, transferrin and retinol-binding protein, measured in central laboratory, at baseline, 3 and 6 months after intervention after intervention 3.3. Serum and intraerythrocytary folic acid concentrations, serum vitamin A, B1, B12, C, E, Zn and Mg concentrations, measured in central laboratory, at baseline, 3 and 6 months after intervention after intervention 3.4. Red blood cell count, hematocrit, mean corpuscular volume, leukocyte count, glucose, creatinine, electrolytes, uric acid, transaminases, lactate dehydrogenase, alkaline phosphatase, gammaglutamyl transpeptidase and bilirrubin, measured in central laboratory, at baseline, 3 and 6 months after intervention after intervention 3.5. Physical activity will be measured using the Minnesota Leisure Time Physical Activity Questionnaire, which has also been validated in Spain, at baseline, 3 and 6 months after intervention 4. Plasma glucose and insulin concentration and Homeostasis Model Assessment (HOMA) will be determined by the | — |
Countries
Spain
Outcome results
None listed