AgingNCT06188949
A Study to Evaluate Efficacy of Dietary Ingredient in Vitality and Metabolic Factors in Healthy Individuals
A study testing Dolichos biflorus (Horsegram) seed extract and Carica papaya leaves extract in people with Aging, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Dolichos biflorus (Horsegram) seed extract and Carica papaya leaves extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesIndia
- Study dates
- 2 Feb 2024to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Dr. Khare's Clinic
Mumbai, Maharashtra, 400053
Dr. Preeti Bawaskar's Clinic
Thane, Maharashtra, 400607
About this study
Official title: 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.
- Conditions
- Aging
- Being tested
- Dolichos biflorus (Horsegram) seed extract, Carica papaya leaves extract, Placebo (MCC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolichos biflorus (Horsegram) seed extractDietary supplement
1 capsule twice a day (Before breakfast \& dinner)
Carica papaya leaves extractDietary supplement
1 capsule twice a day (Before breakfast \& dinner)
Placebo (MCC)Dietary supplement
1 capsule twice a day (Before breakfast \& dinner)
| Study group | Role | What they receive |
|---|---|---|
| Dolichos biflorus (Horsegram) seed extract | Active comparator | 1 capsule twice a day (Before breakfast \& dinner) Receives: Dietary Supplement: Dolichos biflorus (Horsegram) seed extract |
| Carica papaya leaves extract | Active comparator | 1 capsule twice a day (Before breakfast \& dinner) Receives: Dietary Supplement: Carica papaya leaves extract |
| Placebo (MCC) | Placebo comparator | 1 capsule twice a day (Before breakfast \& dinner) Receives: Dietary Supplement: Placebo (MCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Day 90
Secondary outcomes (7)
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
Measured: 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
Measured: 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.
Measured: 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')
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0, Day 14, Day 30, Day 60 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start2 Feb 2024
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blinded study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188949
- Sponsor's protocol ID
- EB/231101/DI/VMF
- Status last verified
- Apr 2024
- First submitted
- 18 Dec 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Feasibility Study to Evaluate Efficacy of Dietary Ingredient in Vitality & Metabolic Factors in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06188949
- Acronym / sponsor ID
- EB/231101/DI/VMF
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, placebo-controlled, double-blinded study
| Arm | Type | Receives |
|---|---|---|
| Dolichos biflorus (Horsegram) seed extract | Active comparator | Dietary Supplement: Dolichos biflorus (Horsegram) seed extract1 capsule twice a day (Before breakfast \& dinner) |
| Carica papaya leaves extract | Active comparator | Dietary Supplement: Carica papaya leaves extract1 capsule twice a day (Before breakfast \& dinner) |
| Placebo (MCC) | Placebo comparator | Dietary Supplement: Placebo (MCC)1 capsule twice a day (Before breakfast \& dinner) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dolichos biflorus (Horsegram) seed extract1 capsule twice a day (Before breakfast \& dinner) | Dietary supplement | Dolichos biflorus (Horsegram) seed extract |
| Carica papaya leaves extract1 capsule twice a day (Before breakfast \& dinner) | Dietary supplement | Carica papaya leaves extract |
| Placebo (MCC)1 capsule twice a day (Before breakfast \& dinner) | Dietary supplement | Placebo (MCC) |
Primary outcome
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).
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).
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dolichos biflorus (Horsegram) seed extract and Carica papaya leaves extract in people with Aging, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.