Clinical trial NCT06188949: A Study to Evaluate Efficacy of Dietary Ingredient in Vitality and Metabolic Factors in Healthy Individuals
Official title: A Randomized, Placebo-controlled, Feasibility Study to Evaluate Efficacy of Dietary Ingredient in Vitality & Metabolic Factors in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-03
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, double-blinded study
Primary purpose: OTHER

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 aged between ≥ 40 and ≤ 60 years will be screened and 36 participants (12 in each arm) are to be randomized. Both the IP and placebo study arms will have 10 completed subjects in each arm after accounting for the screening failure and dropout/withdrawal rate of 30% and 17% respectively (Total 30 completers). The treatment duration for all the study subjects will be 90 days.


Eligibility criteria: Inclusion Criteria:

* 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:

  1. Waist circumference: Men: ≥ 102 cm (40.15 inches); Women ≥88 cm (34.65 inches)
  2. Triglycerides \>150 mg/dL
  3. Systolic Blood pressure (SBP) ≥130 mm Hg and/or Diastolic Blood pressure (DBP) ≥85 mm Hg
  4. Fasting blood glucose ≥ 125 mg/ dl
  5. HDL level: Men: \< 40 mg/dL; Women: \< 50 mg/dL
* Individuals willing to provide signed Consent

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To assess the efficacy of the Investigational Product (IP) on Glucose Metabolism as assessed by change in serum fasting glucose levels.
timeFrame: Day 0
measure: To assess the efficacy of the Investigational Product (IP) on Glucose Metabolism as assessed by change in serum fasting glucose levels.
timeFrame: Day 90
Secondary outcomes:
measure: To assess the efficacy of the Investigational Product (IP) on Fat metabolism as assessed by serum lipid profile.
timeFrame: Day 0 and Day 90
measure: To assess the efficacy of the Investigational Product (IP) on future assessment of vitality related biomarkers
timeFrame: Day 0, Day 30 and Day 90
measure: To assess the efficacy of the Investigational Product (IP) on perceived immune system as assessed by Immune System Questionnaire (ISQ)
timeFrame: Day 0, Day 30, Day 60 and Day 90
measure: To assess the efficacy of the Investigational Product on Physical energy as assessed by energy VAS
timeFrame: Day 0, Day 14, Day 30, Day 60 and Day 90
measure: To assess the efficacy of the Investigational Product on Fatigue level as assessed by Fatigue Severity Scale (FSS)
timeFrame: Day 0, Day 14, Day 30, Day 60 and Day 90
measure: To assess the efficacy of the Investigational Product on Sleep as assessed by Pittsburg Sleep Quality Index
timeFrame: Day 0, Day 14, Day 30, Day 60 and Day 90
measure: To assess the efficacy of the Investigational product on Stress perception as assessed by the Cohen Perceived Stress score
timeFrame: Day 0, Day 14, Day 30, Day 60 and Day 90
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Dr. Khare's Clinic
state: Maharashtra
city: Thane
country: India
facility: Dr. Preeti Bawaskar's Clinic
state: Maharashtra
Study officials:
References: