A clinical study to evaluate the acute and sub-chronic improvement of endothelial function inLI89034F2-supplemented overweight adults with slightly elevated blood pressure
- Registration Number
- CTRI/2019/06/019925
- Lead Sponsor
- aila Nutraceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
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.
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.
Subjects with a known allergy or sensitivity to herbs/spices/plant products in general and/or allergic to botanical ingredients contained in the study products such as Cissus quadrangularis and Trachyspermum ammi Linn.
Subjects with an abnormal resting ECG and elevated resting heart rate (greater than 100 beats per min).
Subjects consuming alcohol (greater than 1 standard drink per day) and smokers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method