An Evaluation of the Effects of a Non-Caffeinated Energy Dietary Supplement

NCT04895800 | Completed

• 1 other identifier: 2019-563
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study tested the effects of a botanical blend to a caffeine and a placebo condition on 1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3) physical performance and 4) stress biomarkers.

Conditions

Health Behavior

Outcome Measures

Primary Outcomes (3)

• Cognition

  Cognitive performance on the NIH Toolbox Cognition Battery and Joggle Psychomotor Vigilance Task. T scores (higher is better) will be reported.

  21 days

• Mood

  Self-reported Mood using the Mood and Physical Sensation Scale (higher scores reflect better mood)

  21 Days

• Physical Performance

  Time to Exhaustion (TTE) Test - running on a treadmill with an increased incline every minute until perceived exhaustion is reached

  21 Days

Study Arms (3)

Herbal Supplement

EXPERIMENTAL

(Phytovive™); comprised of Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins)

Dietary Supplement: Phytovive

Caffeine

ACTIVE COMPARATOR

Green tea caffeine extract (170 mg; to deliver 34 mg caffeine \[20% natural caffeine\]),

Dietary Supplement: Caffeine

Placebo

PLACEBO COMPARATOR

Flavored placebo

Dietary Supplement: Placebo

Interventions

Phytovive DIETARY_SUPPLEMENT

Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins)

Herbal Supplement

Placebo DIETARY_SUPPLEMENT

Natural Flavors \[Chocolate, Caramel, Vanilla Cream\], Silica, Inulin, Sucralose)

Placebo

Caffeine DIETARY_SUPPLEMENT

Caffeine (Green tea caffeine extract (170 mg; to deliver 34 mg caffeine \[20% natural caf-feine\])

Caffeine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult males and females from 18 to 50 years (inclusive) of age who are physically active and have been engaging in athletic and sporting endeavors consistently over a period of 6 months at minimum
• BMI 18.0 (normal) to 34.9 (obese, class I) kg/ m2 inclusive
• Agrees to maintain a stable lifestyle with no change in exercise or diet for the duration of the study
• Current consumer of caffeine either through caffeinated beverages or foods
• Non-smoker
• Able to physically exercise, to run on a treadmill at moderate to high intensity for a brief time (typically less than 20 min)
• Participants with normal blood pressure or participants with hypertension that is controlled (BP \< 160/90 and who are on medication at a stable dose (same dose for ≥90 days)
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, carry out all study-related procedures, communicate effectively with the study staff.
• Females must be using an acceptable method of contraception such as: abstinence, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream), intrauterine device or hormonal contraception (oral, injectable, implantable, transdermal, or vaginal) used consecutively for at least 3 months prior to screening visit, vasectomized partner or use of implants for at least 6 months prior to screening visit; bilateral tubal ligation, hysterectomy, bilateral oophorectomy, or be postmenopausal status with amenorrhea (no menses) for at least 1 year prior to the screening visit.

You may not qualify if:

• Have a known sensitivity or allergy to any of the study products or their ingredients
• Have any medical condition or disease based on the professional judgement and experience of the principal investigator (PI) plus research industry standards that might affect or impact the administration of study products
• Lactating, pregnant or planning to become pregnant during the study
• History of drug or alcohol abuse in the 12 months prior to screening
• History of psychiatric illness requiring hospitalization in the 6 months prior to screening
• History of diabetes (Type I or II) or uncontrolled hypertension (either systolic BP \>160 or diastolic BP \>90)
• Participation in or use of a research IP within 30 days prior to screening (cannot have been in another study within 30 days of screening)

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Nova Southeastern University

Davie, Florida, 33314, United States

Location

Related Publications (3)

• Kongkeaw C, Dilokthornsakul P, Thanarangsarit P, Limpeanchob N, Norman Scholfield C. Meta-analysis of randomized controlled trials on cognitive effects of Bacopa monnieri extract. J Ethnopharmacol. 2014;151(1):528-35. doi: 10.1016/j.jep.2013.11.008. Epub 2013 Nov 16.

  PMID: 24252493 BACKGROUND

• Heaton RK, Akshoomoff N, Tulsky D, Mungas D, Weintraub S, Dikmen S, Beaumont J, Casaletto KB, Conway K, Slotkin J, Gershon R. Reliability and validity of composite scores from the NIH Toolbox Cognition Battery in adults. J Int Neuropsychol Soc. 2014 Jul;20(6):588-98. doi: 10.1017/S1355617714000241. Epub 2014 Jun 24.

  PMID: 24960398 BACKGROUND

• Pickering C, Kiely J. What Should We Do About Habitual Caffeine Use in Athletes? Sports Med. 2019 Jun;49(6):833-842. doi: 10.1007/s40279-018-0980-7.

  PMID: 30173351 BACKGROUND

MeSH Terms

Conditions

Health Behavior

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jaime Tartar, Ph.D.

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A Randomized Double-Blind Placebo-Controlled Study

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: January 3, 2020
• Primary Completion: January 20, 2021
• Study Completion: March 15, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)