Status:
COMPLETED
A Study to Evaluate Efficacy of Dietary Ingredient in Vitality and Metabolic Factors in Healthy Individuals
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
Aging
Eligibility:
All Genders
40-60 years
Phase:
NA
Brief Summary
The present study is a randomized, placebo-controlled, feasibility study to evaluate efficacy of dietary ingredients in vitality \& metabolic factors in healthy individuals. Approximately 54 subjects ...
Eligibility Criteria
Inclusion
- Physically active males and females aged ≥40 and ≤ 60 years
- Individuals with BMI ≥ 24.5 kg/m2 and ≤ 34.9 kg/m2
- Individuals with Fatigue Symptom Severity score ≥36 and ≤45
- Individuals with Perceived Stress score ≥20
- Having at least 2 of the following five metabolic risk factors:
- Waist circumference: Men: ≥ 102 cm (40.15 inches); Women ≥88 cm (34.65 inches)
- Triglycerides \>150 mg/dL
- Systolic Blood pressure (SBP) ≥130 mm Hg and/or Diastolic Blood pressure (DBP) ≥85 mm Hg
- Fasting blood glucose ≥ 125 mg/ dl
- HDL level: Men: \< 40 mg/dL; Women: \< 50 mg/dL
- Individuals willing to provide signed Consent
Exclusion
- Individuals on strict vegetarian diet.
- Individuals with fasting blood sugar ≥160 mg/dl
- Individuals currently hospitalized or planned for admission Individuals
- Individuals currently undergoing treatment with any other drugs such as insulin, corticoids, and non-steroidal anti-inflammatory drugs for more than 15 days.
- Individuals undergoing treatment of chemotherapy and/or suffering from AIDS, hepatitis, pregnancy are precluded from the study.
- Individuals undergoing chemotherapy
- Individuals suffering from AIDS, hepatitis.
- Individuals allergic to components of this nutraceutical formulations.
- Use of medications in the last 2 weeks prior to the pre-baseline period. This does not include birth control pills or standard multi-vitamin/mineral supplements.
- Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
- Abnormal Thyroid Stimulating Hormone (TSH) value which is \< 0.40 or \> 4.50 μIU/mL.
- Diagnosed cases of Type II Diabetes Mellitus with medication
- Hypertensive defined as SBP ≥ 160 mm Hg and/or DBP ≥ 100 mm Hg
- Individuals taking anti-hypertensive
- Individuals with dyslipidemia on medication
- Females in peri-menopausal state (Irregular menstrual period in last 6 months).
- Females on Hormone Replacement Therapy
- Individuals with a history of or complications from inflammatory conditions.
- Use of another investigational product within 3 months of the screening visit
- Individuals with a history of or complications from malignant tumors
- History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
- Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- 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.
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- Any condition that could, in the opinion of the investigator, preclude the individual's ability to successfully and safely complete the study or that may confound study outcomes.
Key Trial Info
Start Date :
February 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06188949
Start Date
February 2 2024
End Date
September 12 2024
Last Update
January 31 2025
Active Locations (2)
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1
Dr. Khare's Clinic
Mumbai, Maharashtra, India, 400053
2
Dr. Preeti Bawaskar's Clinic
Thane, Maharashtra, India, 400607