Healthy overweight individuals aged 45 and over following normal lifestyle Not Applicable Healthy overweight individuals aged 45 and over following normal lifestyle
Conditions
Sponsors
Cultech Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged between 45 to 65 years at start of study 2. Waist circumference >89 cm (women) or >100 cm (men) at start of study 3. Body mass index (BMI) between 25 and 29.9 at start of study 4. Willing to provide fasting blood samples at days 0, 180 and 270
Exclusion criteria
Exclusion criteria: 1. Immunodeficiency/ immunosuppressive therapy on-going 2. Diagnosed diabetes 3. Pregnant or planning pregnancy 4. Anamnesis of ischemic heart disease, heart failure, prolonged QTc interval, rhythm and conduction disorders – absolute arrhythmia, ventricular extrasystole, atrioventricular block or any other cardiovascular disease deemed by the investigator as a risk for the participation in the study 5. Severe systemic disease (cancer, dementia, advanced organ failure) 6. Weight loss in the last 3 months prior to start of study, which cannot be explained with a dietary regimen or increased physical activity 7. Not on statin therapy nor received any statin therapy in the last 6 months prior to start of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 10/06/2020: Body weight (kg) measured on scales at days 0, 90, 180 and 270 Previous primary outcome measure: 1. Body weight (kg) measured on scales at days 0, 90, 180 and 270 2. Waist circumference (cm) measured by tape at days 0, 90, 180 and 270 3. Hip circumference (cm) measured by tape at days 0, 90, 180 and 270 4. Blood pressure (mmHg) measured by a blood pressure monitor at days 0, 90, 180 and 270 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 10/06/2020: 1. Waist circumference (cm) measured by tape at days 0, 90, 180 and 270 2. Hip circumference (cm) measured by tape at days 0, 90, 180 and 270 3. Blood pressure (mmHg) measured by a blood pressure monitor at days 0, 90, 180 and 270 4. Plasma HDL-cholesterol at baseline days 0,180 and 270 5. Plasma LDL-cholesterol at baseline days 0,180 and 270 6. Plasma triacylglycerol at baseline days 0,180 and 270 7. General well-being assessed using a quality of life questionnaire at days 0, 90, 180 and 270 8. Measurement of cognitive performance using Stroop test at days 0, 90, 180 and 270 Previous secondary outcome measures: 1. Plasma HDL-cholesterol at baseline days 0,180 and 270 2. Plasma LDL-cholesterol at baseline days 0,180 and 270 3. Plasma triacylglycerol at baseline days 0,180 and 270 4. General well-being assessed using a quality of life questionnaire at days 0, 90, 180 and 270 5. Measurement of cognitive performance using Stroop test at days 0, 90, 180 and 270 | — |
Countries
Bulgaria
Outcome results
None listed