A Study to Evaluate Efficacy of Dietary Ingredient in Vitality and Metabolic Factors in Healthy Individuals

A Randomized, Placebo-controlled, Feasibility Study to Evaluate Efficacy of Dietary Ingredient in Vitality & Metabolic Factors in Healthy Individuals

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.

Study Overview

• Status: Recruiting
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Dolichos biflorus (Horsegram) seed extract; Dietary supplement: Carica papaya leaves extract; Dietary supplement: Placebo (MCC)

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Shalini Srivastava, MBBS, MD; Phone Number: 02242172300; Email: shalini.s@vediclifesciences.com
• Study Contact Backup: Name: Dr. Shubhangi Mote, BAMS; Phone Number: 02242172300; Email: shubhangi.m@vediclifesciences.com

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400053
      • Recruiting
      • Dr. Khare's Clinic
      • Contact: Dr. Sunira Khare, BHMS; Phone Number: +919664056580; Email: sunira.khare@gmail.com
    • Thane, Maharashtra, India, 400607
      • Recruiting
      • Dr. Preeti Bawaskar's Clinic
      • Contact: Dr. Preeti Bawaskar, BAMS, MD; Phone Number: +919146680080; Email: preeti.bawaskar10@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dolichos biflorus (Horsegram) seed extract; 1 capsule twice a day (Before breakfast & dinner)	Dietary supplement: Dolichos biflorus (Horsegram) seed extract; 1 capsule twice a day (Before breakfast & dinner)
Active Comparator: Carica papaya leaves extract; 1 capsule twice a day (Before breakfast & dinner)	Dietary supplement: Carica papaya leaves extract; 1 capsule twice a day (Before breakfast & dinner)
Placebo Comparator: Placebo (MCC); 1 capsule twice a day (Before breakfast & dinner)	Dietary supplement: Placebo (MCC); 1 capsule twice a day (Before breakfast & dinner)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the efficacy of the Investigational Product (IP) on Glucose Metabolism as assessed by change in serum fasting glucose levels.	The normal values for normal fasting blood glucose concentration are between 4.11-6.05 mmol/L (74-109 mg/dL).	Day 0
To assess the efficacy of the Investigational Product (IP) on Glucose Metabolism as assessed by change in serum fasting glucose levels.	The normal values for normal fasting blood glucose concentration are between 4.11-6.05 mmol/L (74-109 mg/dL).	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the efficacy of the Investigational Product (IP) on Fat metabolism as assessed by serum lipid profile.	Desirable cholesterol level: < 5.17 mmol/L (< 200 mg/dL); Triglycerides: < 1.70 mmol/L (< 150 mg/dL); HDL Cholesterol - Males: 45 - 65 mg/dL, Females: 35 - 55 mg/dL	Day 0 and Day 90
To assess the efficacy of the Investigational Product (IP) on future assessment of vitality related biomarkers	Blood sample will be collected for post hoc analysis	Day 0, Day 30 and Day 90
To assess the efficacy of the Investigational Product (IP) on perceived immune system as assessed by Immune System Questionnaire (ISQ)	The ISQ has seven questions. The sum score is calculated. Interpretation: 0 = very poor and 10= excellent perceived immune status.	Day 0, Day 30, Day 60 and Day 90
To assess the efficacy of the Investigational Product on Physical energy as assessed by energy VAS	The VAS consists of a 10cm line, with two end points representing 0 ('no energy') and 10 ('most energetic')	Day 0, Day 14, Day 30, Day 60 and Day 90
To assess the efficacy of the Investigational Product on Fatigue level as assessed by Fatigue Severity Scale (FSS)	The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 indicates strong agreement, and the final score represents the mean value of the 9 items.	Day 0, Day 14, Day 30, Day 60 and Day 90
To assess the efficacy of the Investigational Product on Sleep as assessed by Pittsburg Sleep Quality Index	In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.	Day 0, Day 14, Day 30, Day 60 and Day 90
To assess the efficacy of the Investigational product on Stress perception as assessed by the Cohen Perceived Stress score	Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.; Scores ranging from 0-13 would be considered low stress.; Scores ranging from 14-26 would be considered moderate stress.; Scores ranging from 27-40 would be considered high perceived stress.	Day 0, Day 14, Day 30, Day 60 and Day 90

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Estimated): June 13, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EB/231101/DI/VMF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No