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

NCT ID: NCT06188949

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2024-09-12

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Dolichos biflorus (Horsegram) seed extract

1 capsule twice a day (Before breakfast \& dinner)

Group Type: ACTIVE_COMPARATOR

Dolichos biflorus (Horsegram) seed extract

Intervention Type: DIETARY_SUPPLEMENT

1 capsule twice a day (Before breakfast \& dinner)

Carica papaya leaves extract

1 capsule twice a day (Before breakfast \& dinner)

Group Type: ACTIVE_COMPARATOR

Carica papaya leaves extract

Intervention Type: DIETARY_SUPPLEMENT

1 capsule twice a day (Before breakfast \& dinner)

Placebo (MCC)

1 capsule twice a day (Before breakfast \& dinner)

Group Type: PLACEBO_COMPARATOR

Placebo (MCC)

Intervention Type: DIETARY_SUPPLEMENT

1 capsule twice a day (Before breakfast \& dinner)

Interventions

Dolichos biflorus (Horsegram) seed extract

1 capsule twice a day (Before breakfast \& dinner)

Intervention Type: DIETARY_SUPPLEMENT

Carica papaya leaves extract

1 capsule twice a day (Before breakfast \& dinner)

Intervention Type: DIETARY_SUPPLEMENT

Placebo (MCC)

1 capsule twice a day (Before breakfast \& dinner)

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr. Khare's Clinic

Mumbai, Maharashtra, India

Dr. Preeti Bawaskar's Clinic

Thāne, Maharashtra, India

Countries

India

Other Identifiers

EB/231101/DI/VMF

Identifier Type: -

Identifier Source: org_study_id