Eligibility |
Inclusion Criteria:
- 1. Participant of either sex, aged = 30 to = 70 years at the time of screening
(completed). 2. Participants with normal to high normal blood pressure (BP) [systolic
BP = 120 and = 139 mm Hg and/or diastolic BP = 80 and = 89 mm Hg] as defined by "The
Task Force for the management of arterial hypertension of the European Society of
Cardiology (ESC) and the European Society of Hypertension (ESH)". 3. Participants with
normal to mildly deranged 'Left ventricular ejection' as per as per American College
of Cardiology: LVEF = 39 and = 55%. 4. BMI = 25 to = 34.9 kg/m2 5. Normal level of
Aspartate transaminase (AST) and Alanine transaminase (ALT) as specified by reference
range of College of American Pathologists certified laboratory. 6. Normal level of
Creatinine as specified by reference range of College of American Pathologists
certified laboratory. 7. Participants must have demonstrated their willingness to
participate in the study and comply with the study procedures and required visits. 8.
Willing to abstain from caffeine, alcohol and related products consumption 12 hours
prior to study visits. 9. Those having the ability to understand and sign a written
informed consent form, which must be completed prior to study specific requirements
being performed. 10. Must be literate and have the ability to complete the study-based
questionnaires and requirements. 11. Female participants of childbearing age must be
willing to use the accepted methods of contraception during the study.
Exclusion Criteria:
- Systolic BP =140 mm Hg and/ or Diastolic BP = 90 mm Hg. 2. Fasting blood sugar = 126
mg/dL 3. Presence of any unstable, acutely symptomatic, or life-limiting illness. 4.
History or presence of clinically significant renal, hepatic, endocrine, biliary,
gastrointestinal, pancreatic or neurologic disorders that, in the judgment of the
investigator, would interfere with the participant's ability to provide informed
consent, comply with the study protocol (that might confound the interpretation of the
study results), or put the participant at undue risk. 5. Using Omega fish oil
supplements, anticonvulsants, Coenzyme Q10, Vitamin K2, proton pump inhibitors, loop
diuretics, anticoagulants, barbiturates, anti-epileptic medications and any herbal
supplements (e.g. flax seeds, chia seeds). 6. Chronic use of anti-inflammatory
medications (= 5 tablets/20 days in last 3 months). 7. Individuals having a history of
smoking or currently smoking and also using any form of smokeless tobacco. 8.
High-risk drinking as defined by consumption of 4 or more alcohol containing beverages
on any day or 8 or more alcohol containing beverages per week for women and 5 or more
alcohol containing beverages on any day or 15 or more alcohol containing beverages per
week for men. 9. Binge drinkers as defined by consumption of 4 or more alcohol
containing beverages for women and 5 or more alcohol containing beverages for men
within 2 hours. 10. Abnormal thyroid stimulating hormone (TSH) levels beyond the
defined reference range (<0.4 and > 4.0 IU/ml) 11. Participants unable to walk. 12.
Participants with history of chronic caffeine use. 13. Participants who have any other
disease or condition, or are using any medication, that in the judgment of the
investigator would put him/her at unacceptable risk for participation in the study or
may interfere with evaluations in the study or noncompliance with treatment or visits.
14. Females who are pregnant/planning to be pregnant/lactating or taking any oral
contraceptives. 15. Females undergoing hormone replacement treatments. 16. Menopausal
females having less than 3 years of menopausal history 17. Those unwilling to abstain
from other dietary supplements or medication (e.g. Hepatoprotective agents and other
traditional medicines - Ayurveda, Siddhi, Chinese herbal medicine, Naturopathy). 18.
Have participated in a study of an investigational product 90 days prior to the
screening. 19. Participants with known or suspected hypersensitivity or intolerance to
Investigational product. 20. Participants who are unable to comply with study
requirements. 21. Any clinical signs or symptoms that in the opinion of investigator,
can jeopardize the outcome of the study.
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