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

NCT06188949 | Completed

• 1 other identifier: EB/231101/DI/VMF
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• To assess the efficacy of the Investigational Product (IP) on Fat metabolism as assessed by serum lipid profile.

  Day 0 and Day 90

• To assess the efficacy of the Investigational Product (IP) on future assessment of vitality related biomarkers

  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)

  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

  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)

  Day 0, Day 14, Day 30, Day 60 and Day 90

Study Arms (3)

Dolichos biflorus (Horsegram) seed extract

ACTIVE COMPARATOR

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

Dietary Supplement: Dolichos biflorus (Horsegram) seed extract

Carica papaya leaves extract

ACTIVE COMPARATOR

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

Dietary Supplement: Carica papaya leaves extract

Placebo (MCC)

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo (MCC)

Interventions

Dolichos biflorus (Horsegram) seed extract DIETARY_SUPPLEMENT

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

Dolichos biflorus (Horsegram) seed extract

Carica papaya leaves extract DIETARY_SUPPLEMENT

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

Carica papaya leaves extract

Placebo (MCC) DIETARY_SUPPLEMENT

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

Placebo (MCC)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (2)

Dr. Khare's Clinic

Mumbai, Maharashtra, 400053, India

Location

Dr. Preeti Bawaskar's Clinic

Thane, Maharashtra, 400607, India

Location

MeSH Terms

Interventions

Seeds

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blinded study

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: February 2, 2024
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: January 31, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)