Overweight and obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Subjects are randomized to three groups:
Group 1: Receives 4 capsules/day of placebo
Group 2: Receives 4 capsules/day of 75 mg each of EBC extract
Group 3: Receives 4 capsules/day of 150 mg each of EB
Sponsors
Biocentury SLU (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females between 20 and 55 years old without documented cardiovascular disease (ischemic heart disease ? angina or recent or old myocardial infarction or previous or cerebral vascular accident, peripheral vascular disease) and who have a body mass index between 27.5 and 34.9 Kg/m2.
Exclusion criteria
Exclusion criteria: Subjects with a previous history of cardiovascular disease (ischemic heart disease ? angina or recent or old myocardial infarction, cerebral vascular accident, or peripheral vascular disease), any severe chronic disease, alcoholism or other toxic abuse will be excluded, as well as those subjects who had taken drugs or followed dietary interventions with potential effects on body weight in the last three months. Subjects who had changed their weight +/-3 kg in the last 3 months were also excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in body weight and body mass index 2. Changes in waist perimeter 3. Changes in fat body mass and distribution of fat in the body measured by DEXA (Dual-energy X-ray Absorptiometry) | — |
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. Blood pressure and heart rate will be measured with an electronic apparatus Omron HEM-705CP (Netherlands). 2. Nutrition assessment, and general analyses : All participants will complete 7-day dietary register during the week previous to the physical and laboratory assessment. We will assess the total quantity of calories ingested in the previous week as well as the proportion corresponding to carbohydrates, lipids and proteins by using the Food Processor Nutrition & Fitness software (esha RESEARCH, Salem, OR, USA) . Overall nutrition will be determined by percentage of ideal weight, lean body mass and body mass index. Waist Perimeter will be measured. The proteic nutrition will be determined on the basis of the following parameters: hemoglobin, total lymphocyte count, total proteins, albumin, prealbumin, transferrin and retinol-binding protein. Serum and intraerythrocytary folic acid concentrations will be measured, as well as serum vitamin A, B1, B12, C, E, B-carotenes, Zn, Mg and Se concentrations. Moreover, the following measurements will also be obtained: red blood cell count, hematocrit, mean corpuscular volume, leukocyte count, glucose, creatinine, electrolytes, uric acid, transaminases, lactate dehydrogenase, alkaline phosphatase, gammaglutamyl transpeptidase and bilirrubin. Physical activity will be measured using the Minnesota Leisure Time Physical Activity Questionnaire. 3. Plasma glucose and insulin concentration and Homeostasis Model Assessment (HOMA) will be determined. 4. Serum lipoproteins and others: Total cholesterol, triglycerides, cHDL, cLDL, Apo A1, Apo B, and lipoprotein (a) will be determined. 5. Diet and exercise monitoring: All participants will follow an isocaloric diet prepared according to their personal preferences. The diet will be strictly monitored during the study. Diet complianc | — |
Countries
Spain
Outcome results
None listed