NCT02816827

Brief Summary

The current study is design to asses the effect of E-AG-01/ E-AG-02/ E-AG-03 on mental alertness as compared to placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 9, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

March 3, 2016

Last Update Submit

September 8, 2016

Conditions

Mental Fatigue

Outcome Measures

Primary Outcomes (1)

  • Alertness

    To assess the effect on mental alertness by Attention network test after ingestion of single dose of investigational product.

    Five hours

Study Arms (4)

E-AG-01

EXPERIMENTAL

550 mg of 2 capsules having AG-01 and AG-07 will be administered orally twice daily for one day.

Dietary Supplement: AG-01Dietary Supplement: AG-07

E-AG-02

EXPERIMENTAL

550 mg of 2 capsules having AG-05 and AG-06 will be administered orally twice daily for one day.

Dietary Supplement: AG-05Dietary Supplement: AG-06

E-AG-03

EXPERIMENTAL

550 mg of 2 capsules having AG-01 and AG-05 will be administered orally twice daily for one day.

Dietary Supplement: AG-01Dietary Supplement: AG-05

E-AG-04

EXPERIMENTAL

550 mg of 2 capsules having AG-06 and AG-07 will be administered orally twice daily for one day.

Dietary Supplement: AG-06Dietary Supplement: AG-07

Interventions

AG-01DIETARY_SUPPLEMENT

Product to increase mental alertness

E-AG-01E-AG-03
AG-05DIETARY_SUPPLEMENT

Product to increase mental alertness

E-AG-02E-AG-03
AG-06DIETARY_SUPPLEMENT

Product to increase mental alertness

E-AG-02E-AG-04
AG-07DIETARY_SUPPLEMENT

Product to increase mental alertness

E-AG-01E-AG-04

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Male and female computer literate subjects (able to use computers/related technology efficiently)in the age group of 18-40 years of age.
  • Subject should be moderate caffeine consumers.
  • All subjects should be predominantly right handed.
  • Subject has a body mass index (BMI) of ≥18.5 and \<25.00 kg/m2.
  • Subjects with Generalized Anxiety Disorder Screener (GAD-7) score ≤ 7.
  • Subjects screened for depression by Patient Health Questionnaire-9 (PHQ-9) with score ≤ 14.
  • Subjects having score of at least 50 ± 20 two out of three readings on Jin Fan's Attention Network Test (ANT) version 1.3.0 after 24 hrs of caffeine abstinence performed at an interval of 30-60 mins each.
  • Subject is willing to refrain from consuming caffeine and caffeine-containing products 24 hrs prior to enrollment and during the study prior to all visit to site.
  • Subject agrees to refrain from using turmeric, ginger, cardamom, lemon grass , galangal, beetle leave, and beetle nuts containing products like thai food, tea masala, thai sauces, mouth freshener, paan, etc on the day prior to clinic visit.
  • Subject is willing to refrain from vigorous physical activity 12 hrs prior to clinic visit.
  • Subject should complete at least 7-8 hours of sleep on the night prior the clinic visit.
  • Subject is a non-smoker.
  • Female subjects currently in their menstrual period can be included only after the last day of menstrual flow.
  • Female Subjects consuming oral contraceptives can be included in study after a washout period of 7 days and are willing to stop its use during the study and opt for barrier contraceptive method.
  • Subject understands the study procedures and signed informed consent form to participate in the study and authorization for release of relevant protected health information to the study Investigator.

You may not qualify if:

  • Subjects unable to abstain from caffeine containing products for 24 hrs.
  • Subjects suffering from primary or secondary insomnia with/ without active treatment.
  • Subjects with Generalized Anxiety Disorder Screener (GAD-7) score \> 7.
  • Subjects with Personal health Questionnaire Score \> 14.
  • Subjects suffering from type II Diabetes Mellitus.
  • Subject having health conditions that would prevent him/her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results.
  • Subject has uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the average blood pressure measured at screening as well as randomization.
  • Subject has a history or presence of clinically significant cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorders that, in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
  • Subject has a history, in the judgment of the investigator, of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
  • Subject has a history or presence of oncological disorders.
  • Pregnant/ planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period.
  • Use of any psychotropic medication within four weeks of screening and throughout the study.
  • Use of antibiotics or signs of active systemic infection. Treatment visits will be rescheduled to allow the subject to wash off of the antibiotic for at least five days prior to any test visit.
  • Subject has had exposure to any non-registered drug product within 30 days prior to the screening visit.
  • Use of any other dietary supplements or herbal products.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vedic Lifesciences

Mumbai, Maharashtra, 400073, India

Location

Related Publications (1)

  • Brunye TT, Mahoney CR, Lieberman HR, Taylor HA. Caffeine modulates attention network function. Brain Cogn. 2010 Mar;72(2):181-8. doi: 10.1016/j.bandc.2009.07.013. Epub 2009 Sep 5.

    PMID: 19733954RESULT

Related Links

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Shalini Srivastav, M D

    Enovate Biolife Pvt Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

June 29, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 9, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)