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

Not Applicable

Completed

• Conditions: Health Behavior
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Phytovive; Dietary Supplement: Caffeine

• Registration Number: NCT04895800
• Lead Sponsor: Nova Southeastern University

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.

Detailed Description

This study aimed to build on this work by investigating the possibility that a specific botanical blend (Phytovive™); comprised of Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins) could improve cognitive and physical performance. To this end, this study was a randomized, double-blind, placebo-controlled 21-day parallel study on 36 healthy adults. The study compared the effects of the botanical blend at baseline 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.

Study Timeline

• Study Start: 2020-01-03
• Primary Completion: 2021-01-20
• Study Completion: 2021-03-15
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-20
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Flavored placebo
Herbal Supplement	Phytovive	(Phytovive™); comprised of Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins)
Caffeine	Caffeine	Green tea caffeine extract (170 mg; to deliver 34 mg caffeine \[20% natural caffeine\]),

Primary Outcome Measures

Name	Time	Method
Mood	21 Days	Self-reported Mood using the Mood and Physical Sensation Scale (higher scores reflect better mood)
Cognition	21 days	Cognitive performance on the NIH Toolbox Cognition Battery and Joggle Psychomotor Vigilance Task. T scores (higher is better) will be reported.
Physical Performance	21 Days	Time to Exhaustion (TTE) Test - running on a treadmill with an increased incline every minute until perceived exhaustion is reached

Trial Locations

Locations (1)

Nova Southeastern University; 🇺🇸 Davie, Florida, United States