A randomized, double-blind, placebo-controlled trial to evaluate the acute and sub-chronicimprovement of endothelial function in LI89034F2-supplemented overweight adults with slightlyelevated blood pressure

aila Nutraceuticals0 sites75 target enrollmentTBD

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: aila Nutraceuticals
Enrollment: 75
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 26, 2019

Last Updated

4 years ago

Study Type

Interventional

Investigators

Sponsor

aila Nutraceuticals

Eligibility Criteria

Inclusion Criteria

•Healthy male and female subjects aged between 30 and 65 years with a Body Mass Index (BMI) between 25 and 29 kg/m2\.
•Subjects with fasting blood glucose level below 100 mg/dL.
•Subjects with slightly elevated blood pressure (systolic blood pressure 120 to 129 mm Hg and diastolic blood pressure less than 80 mm Hg). (A total of four blood pressure screenings can be taken, with the first reading being discarded and calculating the average of the next three readings).
•Subjects willing to be physically active and score International Physical Activity Questionnaire\-Short Form (IPAQ\-SF).
•Subjects have to maintain or limit polyphenol intake throughout the study (i.e. intake of teas, red grapes, dark chocolate, red wine). Need to avoid extreme intakes of foods and drinks that are high in polyphenols (i.e. Not More Than 2 to 3 cup of coffee or tea per day, 1 standard drink of red wine per day, etc.).
•Subjects agree to maintain typical diet and salt intake throughout the study.
•Female subjects who are post\-menopausal or on oral contraceptive or any other birth control methods to avoid pregnancy.
•Subject should provide written informed consent and agree to be available for regular follow up throughout the study duration.
•Subjects who are willing to abstain from nitrate rich foods (eg. beetroot, watermelon, etc) for greater than or equal to 48\-h before each visit.
•Subject considered generally healthy as per health history and routine clinical investigations.

Exclusion Criteria

•Subjects with COPD, asthma, any respiratory or breathing related disorders.
•Women who are pregnant, lactating or planning to become pregnant during the study duration.
•Subjects currently taking prescription medications or natural products that could influence blood pressure (i.e. green tea, resveratrol, sexual health products, etc.)
•Subjects who are participating in another clinical trial or have received any investigational product within 30 days prior to Visit 1 (Screening).
•Subjects with a history of alcohol and/or other drug abuse in the past year.
•Subjects who are currently suffering from a sleep disorder and/or have a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s) that might put the subjects at risk and/or confound the results of the study.
•Subjects with a significant history of medical and/or surgical events that may affect the study outcome or place the subject at risk, including bleeding disorder, cardiovascular disease, diabetes mellitus, thyroid disease, gastrointestinal problems, and metabolic, renal, hepatic, neurological or active musculoskeletal disorders.
•Subjects with a history of being diagnosed with phenylketonuria or any other disease affecting amino acid metabolism (i.e., maple syrup urine disease, etc.).
•Subject who are currently consuming nutritional supplements or medications known to improve hypertension, cardiorespiratory endurance, muscle strength and/or muscle mass (i.e., ribose, protein drinks, amino acids, creatine, HMB, androstenedione, DHEA, shilajit, fenugreek, ashwagandha, etc.), or nitric oxide donors (such as L\-citrulline, L\-arginine), corticosteroids, anabolic drugs and thermogenics within 3 months prior to the start of the study.
•Subject, currently or during the study period, needs to fast as a religious practice.