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

January 29, 2025 updated by: Vedic Lifesciences Pvt. Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400053
        • Dr. Khare's Clinic
      • Thane, Maharashtra, India, 400607
        • Dr. Preeti Bawaskar's Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: Day 0
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.
Time Frame: Day 90
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the efficacy of the Investigational Product (IP) on Fat metabolism as assessed by serum lipid profile.
Time Frame: Day 0 and Day 90
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
Time Frame: Day 0, Day 30 and Day 90
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)
Time Frame: Day 0, Day 30, Day 60 and Day 90
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
Time Frame: Day 0, Day 14, Day 30, Day 60 and Day 90
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)
Time Frame: Day 0, Day 14, Day 30, Day 60 and Day 90
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
Time Frame: Day 0, Day 14, Day 30, Day 60 and Day 90
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
Time Frame: Day 0, Day 14, Day 30, Day 60 and Day 90

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vedic Lifesciences Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EB/231101/DI/VMF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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