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NCT Number: NCT03507023

Effect of Hibiscus and Lippia Extract on Blood Pressure

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.

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Key information

Conditions

Blood Pressure

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Miguel Hernandez de Elche

Elche, Alicante, 03202, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Slight or type 1 hypertension with no pharmacological treatment, but with annual controls of the blood pressure

Exclusion criteria

  • Minors (under 18 years of age)
  • volunteers with high cardiovascular disease risk
  • pharmacological treatment for blood pressure
  • presence of any chronic disease/condition
  • known allergies regarding the supplement and/or placebo

Treatment and study plan

Metabolaid®

Dietary Supplement

500 mg per day, in fasting conditions.

Placebo

Dietary Supplement

500 mg per day, in fasting conditions.

Primary outcomes

  1. Changes in Blood Pressure Measurement with respect to baseline

    Time frame: Continuous measurements for 24 hours, 1 day per week, total 6 weeks

    Using a continuous blood pressure monitor (BPro continuous blood pressure monitor, HealthStats)

  2. Changes in Blood Pressure Measurement with respect to baseline

    Time frame: One measurement per day, 1 day per week, total 6 weeks

    Single Blood Pressure measurements, using the Omron M6 Comfort device

Secondary outcomes

  1. Total Cholesterol

    Time frame: At the beginning and end of the intervention, total 6 weeks

    Blood Sampling in Fasting conditions, in mg/dl

  2. HDL Cholesterol

    Time frame: At the beginning and end of the intervention, total 6 weeks

    Blood Sampling in Fasting conditions, in mg/dl

  3. LDL Cholesterol

    Time frame: At the beginning and end of the intervention, total 6 weeks

    Blood Sampling in Fasting conditions, in mg/dl

  4. Triglycerides

    Time frame: At the beginning and end of the intervention, total 6 weeks

    Blood Sampling in Fasting conditions, in mg/dl

  5. Glucose

    Time frame: At the beginning and end of the intervention, total 6 weeks

    Blood Sampling in Fasting conditions, in mg/dl

  6. Weight, using a weight scale

    Time frame: Once a week, for 6 weeks

    In kg

  7. Height, using measuring tape

    Time frame: Once a week, for 6 weeks

    in cm

  8. BMI, calculated based on Weight and Height

    Time frame: Once a week, for 6 weeks

    in kg/m^2

  9. Waist Circumference, using a measuring tape

    Time frame: Once a week, for 6 weeks

    in cm

  10. Hip Circumference, using a measuring tape

    Time frame: Once a week, for 6 weeks

    in cm

  11. Waist/Hip Ratio

    Time frame: Once a week, for 6 weeks

    Calculated as indicator of obesity, based on Waist and Hip Circumference measurements

  12. Physical Activity Assessment using the Stanford 7-days physical activity recall questionnaire

    Time frame: At baseline, 3 and 6 weeks

    Subjective assessment of physical activity using a validated questionnaire

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Collaborators

  • Hospital General Universitario Elche
  • Monteloeder SL

Registry information

Official study title

Effect of the Combination of Polyphenols Derived From the Hibiscus Sabdariffa and Lippia Citriodora on Slightly Hypertensive or Type 1 Hypertensive Volunteers

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2018
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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