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| Name | Class |
|---|---|
| Hospital General Universitario Elche | OTHER |
| Monteloeder SL | UNKNOWN |
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Determine if a double-blind, randomized, placebo-controlled clinical intervention, based on a dietetic intervention and physical exercise, supplemented with a polyphenolic extract, decreases blood pressure in hypertensive volunteers.
Slightly hypertensive individuals, before diagnosed with type 1 hypertension, are generally monitored by their physician and given dietetic and physical activity guidelines. The objective of this intervention is to prevent onset of a hypertensive pathologic condition. However, in many cases, this intervention is unsuccessful, and therefore the patient must follow-up with anti-hypertensive drugs.
Here, in the current study, the objective is to include a nutritional supplement in the intervention in order to increase the probability of success of the diet/exercise intervention. Previous studies with the supplement Metabolaid has shown the product to significantly decrease the blood pressure of slightly hypertensive individuals. It is estimated, based on the results of previous clinical studies, that the polyphenolic content of the nutritional supplement will reduce at least an additional 10% of the blood pressure of the patients undergoing a diet and exercise intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control | Placebo Comparator | 2 capsules per day, each with 400 mg Cellulose microcrystalline, for 6 weeks. |
|
| Dietetic Supplement Group | Experimental | 2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metabolaid® | Dietary Supplement | 500 mg per day, in fasting conditions. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Blood Pressure Measurement with respect to baseline | Using a continuous blood pressure monitor (BPro continuous blood pressure monitor, HealthStats) | Continuous measurements for 24 hours, 1 day per week, total 6 weeks |
| Changes in Blood Pressure Measurement with respect to baseline | Single Blood Pressure measurements, using the Omron M6 Comfort device | One measurement per day, 1 day per week, total 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol | Blood Sampling in Fasting conditions, in mg/dl | At the beginning and end of the intervention, total 6 weeks |
| HDL Cholesterol | Blood Sampling in Fasting conditions, in mg/dl |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Miguel Hernandez de Elche | Elche | Alicante | 03202 | Spain |
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| Placebo |
| Dietary Supplement |
500 mg per day, in fasting conditions. |
|
| At the beginning and end of the intervention, total 6 weeks |
| LDL Cholesterol | Blood Sampling in Fasting conditions, in mg/dl | At the beginning and end of the intervention, total 6 weeks |
| Triglycerides | Blood Sampling in Fasting conditions, in mg/dl | At the beginning and end of the intervention, total 6 weeks |
| Glucose | Blood Sampling in Fasting conditions, in mg/dl | At the beginning and end of the intervention, total 6 weeks |
| Weight, using a weight scale | In kg | Once a week, for 6 weeks |
| Height, using measuring tape | in cm | Once a week, for 6 weeks |
| BMI, calculated based on Weight and Height | in kg/m^2 | Once a week, for 6 weeks |
| Waist Circumference, using a measuring tape | in cm | Once a week, for 6 weeks |
| Hip Circumference, using a measuring tape | in cm | Once a week, for 6 weeks |
| Waist/Hip Ratio | Calculated as indicator of obesity, based on Waist and Hip Circumference measurements | Once a week, for 6 weeks |
| Physical Activity Assessment using the Stanford 7-days physical activity recall questionnaire | Subjective assessment of physical activity using a validated questionnaire | At baseline, 3 and 6 weeks |